0A4F4F9BD490A749D5437F821CF06DF1
Resolution – RDC No. 20 of 10 April 2014
http://www.saude.pr.gov.br/arquivos/File/RDC_20_de_10_de_abril_2014_Transporte_de_material_Biologico.pdf
http://leaux.net/URLS/ConvertAPI Text Files/727AFA4BED85160098B7C36B92728D9B.en.txt
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / criminal
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p.(None): protection of the population and the environment, when applicable;
p.(None): IV- document, register and file the measures adopted.
p.(None): CHAPTER VI
p.(None): OF THE FINAL AND TRANSITIONAL PROVISIONS
p.(None): Art. 42. The documentation related to the sending, transport and receipt of human biological material must be
p.(None): filed for at least 5 (five) years or according to specific legislation for each type of material
p.(None): human biological.
p.(None): Art. 43. In addition to the provisions of this Resolution, the transport of human biological material must be
p.(None): carried out in accordance with the applicable legislation of other bodies and entities, including:
p.(None): I- Ministries of Transport (MT);
p.(None): II - National Land Transport Agency (ANTT), in the case of land transport; III - National Agency for
p.(None): Civil Aviation (ANAC), in the case of air transport;
p.(None): IV - National Waterway Transportation Agency (ANTAQ), in the case of waterway transportation.
p.(None): Art. 44. The health services and carriers of biological material covered by this Resolution will have
p.(None): the period of 30 (thirty) days from the date of its publication to promote the adjustments
p.(None): necessary for its fulfillment.
p.(None): Art. 45. New carriers of biological material and those who intend to restart their activities must attend
p.(None): to the requirements of this Resolution, from its publication, prior to its beginning of operation.
p.(None): Art. 46. Failure to comply with the provisions contained in this Resolution constitutes a sanitary infraction, in
p.(None): terms of Law No. 6,437, of August 20, 1977, without prejudice to civil liabilities,
p.(None): administrative and criminal penalties.
p.(None): Art. 47. The omitted or exceptional cases verified in the application of this norm will be considered by the
p.(None): competent health surveillance authority under current legislation.
p.(None): Art. 48. This Resolution of the Collegiate Board takes effect on the date of its publication.
p.(None): IVO BUCARESKY
p.(None): ATTACHMENT
p.(None): RISK CLASSIFICATION APPLIED TO THE TRANSPORT OF HUMAN BIOLOGICAL MATERIAL
p.(None): Human biological sample
p.(None): 1- Is it known that the sample does not contain infectious agents?
p.(None): 2- Has the biological material been subjected to processes of neutralization or inactivation of infectious agents?
p.(None): 3- Does biological material contain only microorganisms not pathogenic to humans?
p.(None): 4- Is it a dry blood sample in absorbent material or similar?
p.(None): 5- Is it biological material for therapeutic purposes in transfusion / transplantation?
p.(None): They are not subject to the transportation regulations for dangerous articles in force. Exempt biological material.
p.(None): Check specific regulations according to each material and transport purpose
p.(None): YES NO or NO KNOWS
p.(None): Can it be classified as Category A Biological Material?
p.(None): Yes or no
p.(None): DO NOT KNOW
p.(None): Infectious Substance Category A
p.(None): Biological sample with MINIMUM probability of the presence of infectious agents
p.(None): YES NO or NO
p.(None): IF YOU KNOW
p.(None): Minimum Risk Human Specimen
p.(None): Biological Substance Category B
p.(None): Adapted:
p.(None): 1) WHO - World Health Organization
...
Political / political affiliation
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p.(None): technical and legal requirements established in this Resolution, without prejudice to the provisions of other rules in force
p.(None): peculiar to each biological material and mode of transport.
p.(None): §3 ° The written instrument that proves the outsourcing must be kept at the disposal of the authorities of
p.(None): competent health surveillance by the parties involved in the respective bilateral instrument.
p.(None): §4 ° Outsourcing of biological material transport activity does not exempt the health service
p.(None): sender of compliance with the technical and legal requirements established in the current legislation, responding
p.(None): jointly with the contractor before the health authorities regarding technical, operational and legal aspects
p.(None): inherent to the activities that they are responsible for.
p.(None): §5 ° In the event of transportation of human biological material, carried out by carriers or institutions
p.(None): government agencies, through authorized or established agreements between the Ministry of Health or a body or entity
p.(None): related, such as public security bodies and the Armed Forces, where licensing is not required
p.(None): health, the transport process can be assessed by the local health surveillance authorities
p.(None): competent if necessary.
p.(None): Article 8 - All documents and records of activities related to the transport of biological material
p.(None): they must be available for supply to the health surveillance bodies, whenever requested.
p.(None): Single paragraph. In the case of outsourced activity, it must be expressly stated in the written instrument that proves the
p.(None): outsourcing which documents and records should be kept by each party involved.
p.(None): Art. 9 The personnel directly involved in each stage of the transport process must receive regular training
p.(None): specific, compatible with the function performed and the nature of the material transported, and whenever it occurs
p.(None): change in procedures, and the effectiveness of this training should be periodically assessed.
p.(None): §1 ° The responsibilities for the preparation, execution and evaluation of the training must be defined in the instrument
p.(None): written document that proves outsourcing, according to the technical guidelines defined by the contractor,
p.(None): maintaining documentary records.
p.(None): §2 ° Whenever there is a change in the procedures, it must be ensured that the team is able to carry out the
p.(None): defined guidelines.
p.(None): §3 ° The provisions of the caput and in §§ 1 and 2 do not apply to the transport of tissues, cells and organs for the purpose of
p.(None): transplantation by transporters or government institutions, through an authorized or established agreement with the
p.(None): Ministry of Health or organ or institution that is part of the National Transplantation System, the sender being responsible, in this
p.(None): case, comply with the provisions of art. 29 of this Resolution.
p.(None): CHAPTER III
p.(None): PACKAGING AND PACKAGING
p.(None): Art. 10. The human biological material to be transported must be packaged in such a way as to preserve its
p.(None): integrity and stability, as well as the safety of the personnel involved, during the transport process.
p.(None): Art. 11 The biological material conditioning step must be validated, considering the
p.(None): type of biological material and the purpose of transport, with approval by the responsible technical supervisor
p.(None): by conditioning the biological material to be transported.
...
p.(None): and;
p.(None): VII- telephone contacts, available 24 (twenty four) hours, for cases of accidents and incidents.
p.(None): §1 ° The infectious human biological material classified as Category A or Category B must be
p.(None): transported in packaging labeled according to specific rules for air, land and
p.(None): waterway regulations.
p.(None): §2 ° All human biological material classified as Category A must contain in the tertiary transport packaging, the
p.(None): biohazard label according to specific rules for air, land and water transport
p.(None): in force.
p.(None): Art. 24. For transportation that contains dry ice, liquid nitrogen, cryogenic liquid, non-flammable gas
p.(None): or other conservation and preservation material that poses risks during the transportation process, the
p.(None): packaging and signage must be in accordance with current regulations peculiar to the transportation of material considered
p.(None): dangerous.
p.(None): Art. 25. When dealing with human biological material that cannot be subjected to radiation (X-rays), as
p.(None): characteristic must be clearly indicated on the tertiary packaging.
p.(None): CHAPTER V
p.(None): RESPONSIBILITIES
p.(None): Art. 26. The responsibilities of the sender, carrier and recipient must be defined and documented
p.(None): written instrument covering, at the stage of the transport process that is appropriate:
p.(None): I - measures related to the shipping documentation required to transport biological material;
p.(None): II - adoption of biosafety measures;
p.(None): III - guarantee of the necessary conditions for the conservation and stability of biological material;
p.(None): IV - preparation of written instructions according to the activities developed by each party; and
p.(None): V - the definition of the logistics to be used and the communication mechanism between the parties involved.
p.(None): Single paragraph. For the international transport of human biological material, the
p.(None): responsibility for the documentation to be obtained rests with the importer / exporter.
p.(None): Sender Section I
p.(None): Art. 27. The sender must ensure compliance with the requirements provided for in this Resolution, without
p.(None): prejudice to the provisions of other current norms peculiar to each material and mode of transport, for the
p.(None): transport of human biological material, with due advance in relation to the respective air, land or
p.(None): waterway.
p.(None): Art. 28. The sender is responsible for the safe packaging of the material to be transported according to its type
p.(None): and classification.
p.(None): Single paragraph. The identification of the professional who stored the biological material for
p.(None): transport.
p.(None): Art. 29. The sender must provide those involved in the transportation process with technical information regarding the
p.(None): transported material, including procedures and care for the material, biological risk and
p.(None): emergency to be adopted in the event of an accident or fact that exposes the carrier, the population or the environment to
p.(None): human biological material.
p.(None): § 1 In the event that the sender uses the transport company service in his transport process
p.(None): road, rail, waterway or air operator passengers and cargo, which are not subject to the
p.(None): health licensing, the sender will be responsible for verifying the technical conditions under which
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Health / Drug Usage
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p.(None): biological material of human origin in its different modalities and forms, without prejudice to the provisions of other
p.(None): current rules peculiar to each material and mode of transport, to ensure safety, minimize risks
p.(None): sanitary conditions and preserve the integrity of the material transported.
p.(None): Section II Scope
p.(None): Art. 2 This Resolution applies to all sender, carrier, recipient and others involved in the
p.(None): transport process of human biological material, without prejudice to the provisions of other current norms peculiar to
p.(None): each material and mode of transport.
p.(None): Single paragraph. The provisions of this Resolution apply as applicable, to import and export procedures
p.(None): export of human biological material, without prejudice to the provisions of other current norms peculiar to each
p.(None): material and mode of transport.
p.(None): Section III Definitions
p.(None): Art. 3 For the purposes of this Resolution, the following definitions are adopted:
p.(None): I - packaging of human biological material: procedure for packaging human biological material with the
p.(None): purpose of transportation, aiming at the protection of material, people and the environment during all stages of the
p.(None): transportation to its final destination;
p.(None): II - Category A: infectious biological material whose exposure may cause disability
p.(None): permanent or deadly disease, endangering human or other animal life flagged as UN 2814 or UN 2900
p.(None): if it affects only animals.
p.(None): III - Category B: infectious biological material not included in category A, classified as "substance
p.(None): biological test "Category B" UN 3373, inserting into this group samples of patients that are suspected or
p.(None): know how to contain infectious agents that cause disease in humans;
p.(None): IV - Minimum Specimen Human Specimen Category: adapted from English "Exempt Human Specimen", includes
p.(None): biological materials from healthy individuals who have been subjected to professional judgment based on
p.(None): clinical history, symptoms and individual characteristics, as well as local endemic conditions that
p.(None): ensure the minimum likelihood of biological material containing pathogenic microorganisms, even if these
p.(None): materials have not previously been tested for markers of communicable disease by the
p.(None): blood, following the guidelines of the World Health Organization (WHO);
p.(None): V - biological risk classification: level of risk in relation to exposure to biological agents, determined
p.(None): by pathogenesis, mode, relative ease of transmission through biological materials and
p.(None): reversibility of the disease due to the availability of known and effective treatments and preventives;
p.(None): VI - recipient: any legal person, public or private, responsible for receiving
p.(None): the human biological material transported;
p.(None): VII - primary packaging: packaging that is in direct contact with the biological material to be transported,
p.(None): constituting a container, wrap or any other form of protection, removable or not, which is intended
p.(None): to fill, maintain, contain, cover or package the biological material to be transported, also called
p.(None): inner packaging;
p.(None): VIII - secondary packaging: intermediate packaging, placed between the primary packaging and the tertiary packaging, with
p.(None): purposes of containing primary packaging;
p.(None): IX - tertiary packaging: external packaging, used exclusively for cargo protection in operations
p.(None): handling (loading, unloading and transportation) and storage;
p.(None): X - label: identification affixed to the label, without erasures and that does not compromise the information
p.(None): label originals;
p.(None): XI - absorbent material: material placed between the primary and secondary packaging in quantity
p.(None): enough to contain the entire content of biological material in the primary packaging ensuring the integrity of the
p.(None): tertiary packaging;
p.(None): XII - human biological material: tissue or fluid constituting the human organism, such as excrement, fluids
p.(None): bodily, cells, tissues, organs or other fluids of human origin or isolated from them;
p.(None): XIII - refrigerant material: material or substance capable of conserving biological material in a range of
p.(None): temperature, previously specified, during the transport process;
p.(None): XIV - mode of transport: mechanism, alternative or type of transport vehicle used to move the material
p.(None): human biological;
p.(None): XV - sender: any legal person, of a public or private nature, also called a sender or
p.(None): shipper, responsible for preparing and sending human biological material to a recipient,
p.(None): transport;
p.(None): XVI - labeling: procedure for labeling, marking and labeling packages intended for the transport of
p.(None): human biological material;
p.(None): XVII - label: corresponds to the printed or lithographed identification and the words painted or engraved on
p.(None): fire, pressure or self-adhesive, applied directly on containers, packaging, wrappers, wraps,
p.(None): cartridges and any other packaging protector and cannot be removed or altered during transportation and
p.(None): storage;
p.(None): XVIII - technical supervisor: trained and designated professional to perform the activities of implementation, execution
p.(None): and monitoring of biological material transport processes;
p.(None): XIX - transporter: natural or legal person who transports human biological material
p.(None): from a sender to a specified recipient including commercial, public or
p.(None): private and self-loading;
p.(None): XX - validation: set of actions used to prove that operational procedures, processes,
p.(None): activities or systems produce the expected result with exercises conducted according to protocols previously
p.(None): defined and approved, with description of tests and acceptance criteria.
p.(None): CHAPTER II
p.(None): INITIAL PROVISIONS
p.(None): Art. 4 The transportation of human biological material is subject to the established rules and procedures
...
p.(None): case, comply with the provisions of art. 29 of this Resolution.
p.(None): CHAPTER III
p.(None): PACKAGING AND PACKAGING
p.(None): Art. 10. The human biological material to be transported must be packaged in such a way as to preserve its
p.(None): integrity and stability, as well as the safety of the personnel involved, during the transport process.
p.(None): Art. 11 The biological material conditioning step must be validated, considering the
p.(None): type of biological material and the purpose of transport, with approval by the responsible technical supervisor
p.(None): by conditioning the biological material to be transported.
p.(None): §1 ° If temperature control is necessary, this parameter must be considered in the process of
p.(None): transport validation, in order to guarantee conservation of biological characteristics for the duration of
p.(None): planned transport, with estimated delay margin.
p.(None): §2 ° Any changes in packaging and packaging operations and technical characteristics defined in
p.(None): validation will be evaluated by the technical supervisor as to the need for revalidation, keeping the records
p.(None): documentary.
p.(None): Art. 12. The packaging system must be used according to the specificities of the biological material transported.
p.(None): Single paragraph. The packaging referred to in the caput must be used exclusively for transportation purposes
p.(None): and made up of appropriate material, in accordance with the provisions of this Resolution, without prejudice to the
p.(None): other current norms peculiar to each material and mode of transport and, in the alternative, in the instructions of the
p.(None): packaging manufacturer.
p.(None): Art. 13. For human biological material classified as an infectious substance Category A UN 2814 must be
p.(None): the current normative provisions regarding the PI 620 packaging instruction are applied, without prejudice to the
p.(None): other regulations in force specific to each material and mode of transport.
p.(None): Art. 14. For human biological material classified as Category B UN 3373 biological substance, the following must be
p.(None): the current normative provisions regarding the PI 650 packaging instruction are applied, without prejudice to the
p.(None): other regulations in force specific to each material and mode of transport.
p.(None): Art. 15. For the Human Specimen Category of Minimum Risk, the following minimum requirements must be applied
p.(None): without prejudice to the provisions of other current norms peculiar to each material and method of
p.(None): transport:
p.(None): I - primary packaging, equipped with a device that guarantees leak-proof and impermeable sealing for
p.(None): liquid samples, and in the case of solid or semi-solid samples, resistant container with
p.(None): closure that prevents the material from overflowing.
p.(None): II - rigid, resistant tertiary packaging, of adequate size to the biological material transported, and
p.(None): equipped with a closing device, observing that washable and resistant to disinfectant materials can
p.(None): be reusable.
p.(None): III - secondary packaging of resistant material in order to contain the primary packaging, leak-proof.
p.(None): Single paragraph. For biological samples transported in fragile, breakable inner packaging,
p.(None): hole or crack, it is necessary to observe the following aspects:
p.(None): a) the primary packaging (s) must be arranged in such a way as to avoid shocks between them and / or
p.(None): with the packaging that
p.(None): (s) involves, in order to maintain the integrity of the material transported; and
p.(None): b) for liquid samples, absorbent material must be used as part of the packaging system.
p.(None): in order to absorb the entire contents of the primary packaging (s) in the event of material overflow.
...
p.(None): to the requirements of this Resolution, from its publication, prior to its beginning of operation.
p.(None): Art. 46. Failure to comply with the provisions contained in this Resolution constitutes a sanitary infraction, in
p.(None): terms of Law No. 6,437, of August 20, 1977, without prejudice to civil liabilities,
p.(None): administrative and criminal penalties.
p.(None): Art. 47. The omitted or exceptional cases verified in the application of this norm will be considered by the
p.(None): competent health surveillance authority under current legislation.
p.(None): Art. 48. This Resolution of the Collegiate Board takes effect on the date of its publication.
p.(None): IVO BUCARESKY
p.(None): ATTACHMENT
p.(None): RISK CLASSIFICATION APPLIED TO THE TRANSPORT OF HUMAN BIOLOGICAL MATERIAL
p.(None): Human biological sample
p.(None): 1- Is it known that the sample does not contain infectious agents?
p.(None): 2- Has the biological material been subjected to processes of neutralization or inactivation of infectious agents?
p.(None): 3- Does biological material contain only microorganisms not pathogenic to humans?
p.(None): 4- Is it a dry blood sample in absorbent material or similar?
p.(None): 5- Is it biological material for therapeutic purposes in transfusion / transplantation?
p.(None): They are not subject to the transportation regulations for dangerous articles in force. Exempt biological material.
p.(None): Check specific regulations according to each material and transport purpose
p.(None): YES NO or NO KNOWS
p.(None): Can it be classified as Category A Biological Material?
p.(None): Yes or no
p.(None): DO NOT KNOW
p.(None): Infectious Substance Category A
p.(None): Biological sample with MINIMUM probability of the presence of infectious agents
p.(None): YES NO or NO
p.(None): IF YOU KNOW
p.(None): Minimum Risk Human Specimen
p.(None): Biological Substance Category B
p.(None): Adapted:
p.(None): 1) WHO - World Health Organization
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.(None): neutralization / inactivation, which are dry biological materials
p.(None): collected in specific devices, blood and components for transfusion, cells, tissues and organs for
p.(None): transplantation, the provisions of article 15 shall apply for packaging procedures, without prejudice to the
p.(None): other regulations in force specific to each material and mode of transport.
p.(None): Art. 17. To classify the human biological material to be transported, use the diagram of
p.(None): risk classification applied to the transport of human biological material according to the guidelines of the
p.(None): World Health Organization (WHO), in accordance with the Annex to this Resolution, without prejudice to the provisions of other
p.(None): current norms peculiar to each material and mode of transport.
p.(None): Art. 18. In the case of the use of overpacking mechanisms for packaging of packages, it must be ensured
p.(None): that each package is correctly labeled and signaled, in accordance with the provisions of this Resolution, without
p.(None): prejudice to the provisions of other current rules peculiar to each material and mode of transport.
p.(None): Art. 19. Only packages made of materials that can be cleaned, dried and disinfected or
p.(None): sterilization, if technically justified, can be reused, through defined protocols and
p.(None): maintaining records of procedures performed.
p.(None): CHAPTER IV LABELING
p.(None): Art. 20. The labeling must be in accordance with the type, risk classification and
p.(None): conservation of human biological material transported.
p.(None): Art. 21. The information contained in the label and the label must be legible, understandable, expressed in language
p.(None): Portuguese with indelible ink, waterproof and on a background of contrasting color, with proportional dimensions to the
p.(None): size of the packaging, without prejudice to the provisions of other current norms peculiar to each material and method of
p.(None): transport.
p.(None): Sole paragraph: In the case of importation of biological material, the information expressed in Portuguese
p.(None): or English language.
p.(None): Art. 22. The label and the label must remain firmly adhered to the packaging, and cannot be
p.(None): streaked, tampered with or covered by labels, marks or packaging parts.
p.(None): Art. 23. The tertiary packaging must contain, at least, without prejudice to the provisions of other current rules
p.(None): peculiar to each material and mode of transport:
p.(None): I - identification of the sender and recipient, in addition to full addresses and contact telephone numbers;
p.(None): II - appropriate identification of biological material;
p.(None): III- label and marking referring to the type of biological material transported, when applicable; IV- phrases of
p.(None): warnings, when applicable;
p.(None): V- signaling of the mode and direction of opening, when applicable; VI- marking of approved packaging, when applicable
p.(None): and;
p.(None): VII- telephone contacts, available 24 (twenty four) hours, for cases of accidents and incidents.
p.(None): §1 ° The infectious human biological material classified as Category A or Category B must be
p.(None): transported in packaging labeled according to specific rules for air, land and
p.(None): waterway regulations.
p.(None): §2 ° All human biological material classified as Category A must contain in the tertiary transport packaging, the
p.(None): biohazard label according to specific rules for air, land and water transport
p.(None): in force.
p.(None): Art. 24. For transportation that contains dry ice, liquid nitrogen, cryogenic liquid, non-flammable gas
p.(None): or other conservation and preservation material that poses risks during the transportation process, the
p.(None): packaging and signage must be in accordance with current regulations peculiar to the transportation of material considered
p.(None): dangerous.
p.(None): Art. 25. When dealing with human biological material that cannot be subjected to radiation (X-rays), as
...
Social / Marital Status
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p.(None): Resolution of the Collegiate Board - RDC nº 20, of April 10, 2014
p.(None): Provides for health regulations for the transport of human biological material.
p.(None): The Collegiate Directorate of the National Health Surveillance Agency, in the use of the powers conferred on it by the items
p.(None): III and IV, of art. 15 of Law No. 9,782, of January 26, 1999, item II, and §§ 1 and 3 of art. 54 of
p.(None): Internal Regulation approved pursuant to Annex I of ANVISA Ordinance No. 354, of August 11, 2006,
p.(None): republished in the DOU of August 21, 2006, and its updates, in view of the provisions of items III, of art. 2nd,
p.(None): III and IV, of article 7 of Law 9.782, of 1999, and the Program for Improvement of the Regulatory Process of the
p.(None): Agency, established through Ordinance No. 422, of April 16, 2008, in a meeting held in
p.(None): March 25, 2014, adopts the following Resolution of the Collegiate Board and I, the Chief Executive Officer
p.(None): Substitute, I determine its publication:
p.(None): CHAPTER I
p.(None): INITIAL PROVISIONS
p.(None): Section I Purpose
p.(None): Art. 1 This Resolution has the objective of defining and establishing sanitary standards for the transportation of
p.(None): biological material of human origin in its different modalities and forms, without prejudice to the provisions of other
p.(None): current rules peculiar to each material and mode of transport, to ensure safety, minimize risks
p.(None): sanitary conditions and preserve the integrity of the material transported.
p.(None): Section II Scope
p.(None): Art. 2 This Resolution applies to all sender, carrier, recipient and others involved in the
p.(None): transport process of human biological material, without prejudice to the provisions of other current norms peculiar to
p.(None): each material and mode of transport.
p.(None): Single paragraph. The provisions of this Resolution apply as applicable, to import and export procedures
p.(None): export of human biological material, without prejudice to the provisions of other current norms peculiar to each
p.(None): material and mode of transport.
p.(None): Section III Definitions
p.(None): Art. 3 For the purposes of this Resolution, the following definitions are adopted:
p.(None): I - packaging of human biological material: procedure for packaging human biological material with the
p.(None): purpose of transportation, aiming at the protection of material, people and the environment during all stages of the
p.(None): transportation to its final destination;
p.(None): II - Category A: infectious biological material whose exposure may cause disability
p.(None): permanent or deadly disease, endangering human or other animal life flagged as UN 2814 or UN 2900
p.(None): if it affects only animals.
p.(None): III - Category B: infectious biological material not included in category A, classified as "substance
p.(None): biological test "Category B" UN 3373, inserting into this group samples of patients that are suspected or
p.(None): know how to contain infectious agents that cause disease in humans;
p.(None): IV - Minimum Specimen Human Specimen Category: adapted from English "Exempt Human Specimen", includes
p.(None): biological materials from healthy individuals who have been subjected to professional judgment based on
p.(None): clinical history, symptoms and individual characteristics, as well as local endemic conditions that
p.(None): ensure the minimum likelihood of biological material containing pathogenic microorganisms, even if these
p.(None): materials have not previously been tested for markers of communicable disease by the
...
p.(None): human biological;
p.(None): XV - sender: any legal person, of a public or private nature, also called a sender or
p.(None): shipper, responsible for preparing and sending human biological material to a recipient,
p.(None): transport;
p.(None): XVI - labeling: procedure for labeling, marking and labeling packages intended for the transport of
p.(None): human biological material;
p.(None): XVII - label: corresponds to the printed or lithographed identification and the words painted or engraved on
p.(None): fire, pressure or self-adhesive, applied directly on containers, packaging, wrappers, wraps,
p.(None): cartridges and any other packaging protector and cannot be removed or altered during transportation and
p.(None): storage;
p.(None): XVIII - technical supervisor: trained and designated professional to perform the activities of implementation, execution
p.(None): and monitoring of biological material transport processes;
p.(None): XIX - transporter: natural or legal person who transports human biological material
p.(None): from a sender to a specified recipient including commercial, public or
p.(None): private and self-loading;
p.(None): XX - validation: set of actions used to prove that operational procedures, processes,
p.(None): activities or systems produce the expected result with exercises conducted according to protocols previously
p.(None): defined and approved, with description of tests and acceptance criteria.
p.(None): CHAPTER II
p.(None): INITIAL PROVISIONS
p.(None): Art. 4 The transportation of human biological material is subject to the established rules and procedures
p.(None): in this Resolution, without prejudice to the provisions of other current rules specific to each material and mode of transport.
p.(None): Art. 5 The transport operations must be registered and standardized through updated written instructions.
p.(None): Single paragraph. Standardized written instructions should be available to all personnel involved in the
p.(None): transportation process and be reviewed annually and / or whenever changes in procedures occur.
p.(None): Art. 6 Any non-conformities during the transportation process must be investigated and registered,
p.(None): including, where applicable, the corrective and preventive measures adopted.
p.(None): Art. 7 The transport of human biological material can be carried out on an outsourced basis, through
p.(None): written instrument that proves the outsourcing, obeying the specifications of the human biological material to
p.(None): be transported.
p.(None): §1 ° The outsourced service provider must be legally constituted and licensed by the supervisory body
p.(None): competent local health authority, pursuant to this Resolution and the federal, state and federal health surveillance rules
p.(None): relevant municipalities.
p.(None): §2 ° The outsourced service provider must have infrastructure, knowledge and adequate training of personnel,
p.(None): under the technical supervision of a professional proven to be able to perform the service satisfactorily
p.(None): requested by the contractor and meet the requirements
p.(None): technical and legal requirements established in this Resolution, without prejudice to the provisions of other rules in force
p.(None): peculiar to each biological material and mode of transport.
p.(None): §3 ° The written instrument that proves the outsourcing must be kept at the disposal of the authorities of
p.(None): competent health surveillance by the parties involved in the respective bilateral instrument.
p.(None): §4 ° Outsourcing of biological material transport activity does not exempt the health service
p.(None): sender of compliance with the technical and legal requirements established in the current legislation, responding
p.(None): jointly with the contractor before the health authorities regarding technical, operational and legal aspects
p.(None): inherent to the activities that they are responsible for.
p.(None): §5 ° In the event of transportation of human biological material, carried out by carriers or institutions
p.(None): government agencies, through authorized or established agreements between the Ministry of Health or a body or entity
p.(None): related, such as public security bodies and the Armed Forces, where licensing is not required
p.(None): health, the transport process can be assessed by the local health surveillance authorities
p.(None): competent if necessary.
p.(None): Article 8 - All documents and records of activities related to the transport of biological material
p.(None): they must be available for supply to the health surveillance bodies, whenever requested.
p.(None): Single paragraph. In the case of outsourced activity, it must be expressly stated in the written instrument that proves the
p.(None): outsourcing which documents and records should be kept by each party involved.
p.(None): Art. 9 The personnel directly involved in each stage of the transport process must receive regular training
p.(None): specific, compatible with the function performed and the nature of the material transported, and whenever it occurs
p.(None): change in procedures, and the effectiveness of this training should be periodically assessed.
p.(None): §1 ° The responsibilities for the preparation, execution and evaluation of the training must be defined in the instrument
p.(None): written document that proves outsourcing, according to the technical guidelines defined by the contractor,
p.(None): maintaining documentary records.
p.(None): §2 ° Whenever there is a change in the procedures, it must be ensured that the team is able to carry out the
p.(None): defined guidelines.
p.(None): §3 ° The provisions of the caput and in §§ 1 and 2 do not apply to the transport of tissues, cells and organs for the purpose of
p.(None): transplantation by transporters or government institutions, through an authorized or established agreement with the
p.(None): Ministry of Health or organ or institution that is part of the National Transplantation System, the sender being responsible, in this
p.(None): case, comply with the provisions of art. 29 of this Resolution.
p.(None): CHAPTER III
p.(None): PACKAGING AND PACKAGING
p.(None): Art. 10. The human biological material to be transported must be packaged in such a way as to preserve its
p.(None): integrity and stability, as well as the safety of the personnel involved, during the transport process.
p.(None): Art. 11 The biological material conditioning step must be validated, considering the
p.(None): type of biological material and the purpose of transport, with approval by the responsible technical supervisor
p.(None): by conditioning the biological material to be transported.
p.(None): §1 ° If temperature control is necessary, this parameter must be considered in the process of
p.(None): transport validation, in order to guarantee conservation of biological characteristics for the duration of
p.(None): planned transport, with estimated delay margin.
p.(None): §2 ° Any changes in packaging and packaging operations and technical characteristics defined in
p.(None): validation will be evaluated by the technical supervisor as to the need for revalidation, keeping the records
p.(None): documentary.
p.(None): Art. 12. The packaging system must be used according to the specificities of the biological material transported.
p.(None): Single paragraph. The packaging referred to in the caput must be used exclusively for transportation purposes
p.(None): and made up of appropriate material, in accordance with the provisions of this Resolution, without prejudice to the
p.(None): other current norms peculiar to each material and mode of transport and, in the alternative, in the instructions of the
p.(None): packaging manufacturer.
p.(None): Art. 13. For human biological material classified as an infectious substance Category A UN 2814 must be
p.(None): the current normative provisions regarding the PI 620 packaging instruction are applied, without prejudice to the
p.(None): other regulations in force specific to each material and mode of transport.
p.(None): Art. 14. For human biological material classified as Category B UN 3373 biological substance, the following must be
p.(None): the current normative provisions regarding the PI 650 packaging instruction are applied, without prejudice to the
p.(None): other regulations in force specific to each material and mode of transport.
p.(None): Art. 15. For the Human Specimen Category of Minimum Risk, the following minimum requirements must be applied
p.(None): without prejudice to the provisions of other current norms peculiar to each material and method of
p.(None): transport:
p.(None): I - primary packaging, equipped with a device that guarantees leak-proof and impermeable sealing for
p.(None): liquid samples, and in the case of solid or semi-solid samples, resistant container with
p.(None): closure that prevents the material from overflowing.
p.(None): II - rigid, resistant tertiary packaging, of adequate size to the biological material transported, and
p.(None): equipped with a closing device, observing that washable and resistant to disinfectant materials can
p.(None): be reusable.
p.(None): III - secondary packaging of resistant material in order to contain the primary packaging, leak-proof.
p.(None): Single paragraph. For biological samples transported in fragile, breakable inner packaging,
p.(None): hole or crack, it is necessary to observe the following aspects:
p.(None): a) the primary packaging (s) must be arranged in such a way as to avoid shocks between them and / or
p.(None): with the packaging that
p.(None): (s) involves, in order to maintain the integrity of the material transported; and
p.(None): b) for liquid samples, absorbent material must be used as part of the packaging system.
p.(None): in order to absorb the entire contents of the primary packaging (s) in the event of material overflow.
p.(None): Art. 16. For human biological material that does not fall under the classifications of articles 13, 14 and 15 and that
p.(None): are known to be free of infectious agents, or have undergone
p.(None): neutralization / inactivation, which are dry biological materials
p.(None): collected in specific devices, blood and components for transfusion, cells, tissues and organs for
p.(None): transplantation, the provisions of article 15 shall apply for packaging procedures, without prejudice to the
p.(None): other regulations in force specific to each material and mode of transport.
p.(None): Art. 17. To classify the human biological material to be transported, use the diagram of
p.(None): risk classification applied to the transport of human biological material according to the guidelines of the
p.(None): World Health Organization (WHO), in accordance with the Annex to this Resolution, without prejudice to the provisions of other
p.(None): current norms peculiar to each material and mode of transport.
p.(None): Art. 18. In the case of the use of overpacking mechanisms for packaging of packages, it must be ensured
p.(None): that each package is correctly labeled and signaled, in accordance with the provisions of this Resolution, without
...
p.(None): §1 ° The infectious human biological material classified as Category A or Category B must be
p.(None): transported in packaging labeled according to specific rules for air, land and
p.(None): waterway regulations.
p.(None): §2 ° All human biological material classified as Category A must contain in the tertiary transport packaging, the
p.(None): biohazard label according to specific rules for air, land and water transport
p.(None): in force.
p.(None): Art. 24. For transportation that contains dry ice, liquid nitrogen, cryogenic liquid, non-flammable gas
p.(None): or other conservation and preservation material that poses risks during the transportation process, the
p.(None): packaging and signage must be in accordance with current regulations peculiar to the transportation of material considered
p.(None): dangerous.
p.(None): Art. 25. When dealing with human biological material that cannot be subjected to radiation (X-rays), as
p.(None): characteristic must be clearly indicated on the tertiary packaging.
p.(None): CHAPTER V
p.(None): RESPONSIBILITIES
p.(None): Art. 26. The responsibilities of the sender, carrier and recipient must be defined and documented
p.(None): written instrument covering, at the stage of the transport process that is appropriate:
p.(None): I - measures related to the shipping documentation required to transport biological material;
p.(None): II - adoption of biosafety measures;
p.(None): III - guarantee of the necessary conditions for the conservation and stability of biological material;
p.(None): IV - preparation of written instructions according to the activities developed by each party; and
p.(None): V - the definition of the logistics to be used and the communication mechanism between the parties involved.
p.(None): Single paragraph. For the international transport of human biological material, the
p.(None): responsibility for the documentation to be obtained rests with the importer / exporter.
p.(None): Sender Section I
p.(None): Art. 27. The sender must ensure compliance with the requirements provided for in this Resolution, without
p.(None): prejudice to the provisions of other current norms peculiar to each material and mode of transport, for the
p.(None): transport of human biological material, with due advance in relation to the respective air, land or
p.(None): waterway.
p.(None): Art. 28. The sender is responsible for the safe packaging of the material to be transported according to its type
p.(None): and classification.
p.(None): Single paragraph. The identification of the professional who stored the biological material for
p.(None): transport.
p.(None): Art. 29. The sender must provide those involved in the transportation process with technical information regarding the
p.(None): transported material, including procedures and care for the material, biological risk and
p.(None): emergency to be adopted in the event of an accident or fact that exposes the carrier, the population or the environment to
p.(None): human biological material.
p.(None): § 1 In the event that the sender uses the transport company service in his transport process
p.(None): road, rail, waterway or air operator passengers and cargo, which are not subject to the
p.(None): health licensing, the sender will be responsible for verifying the technical conditions under which
p.(None): this part of the process will be carried out and monitoring the delivery and arrival of the material at its destination
p.(None): by means of a written instrument proving outsourcing, without prejudice to the provisions of other
p.(None): current rules peculiar to each material and mode of transport.
p.(None): § 2 The competent health authority may assess, when deemed necessary, the technical health conditions of the
p.(None): transport of human biological material referred to in § 1 °.
p.(None): Art. 30. The sender must inform the recipient about specific information regarding the
p.(None): transportation, the date and the estimated time of arrival at the destination, when applicable, as established in
p.(None): written instrument that proves the relationship between the parties, so that the cargo can be received promptly.
p.(None): Section II
p.(None): From Carrier
p.(None): Art. 31. The carrier must guarantee the necessary infrastructure for the process of transporting biological material
p.(None): considering the respective type and risk classification.
p.(None): Art. 32. During the transportation of human biological material, the carrier must carry a document that
p.(None): allow the traceability of the shipment / cargo transported.
p.(None): Art. 33. The carrier must check the packaging and documentation conditions upon receipt of the material
p.(None): for the transport of human biological material and contact the sender, in case of finding
p.(None): any non-conformity in the packaging and / or documentation, for taking corrective measures applicable in time
p.(None): skilled for transportation.
p.(None): Art. 34. The transport vehicle must have adequate hygiene and cleaning conditions, as well as have
p.(None): mechanism that ensures the integrity of the tertiary packaging and the biological material transported.
p.(None): Section III Of the Recipient
p.(None): Art. 35. The recipient must guarantee the opening of the packages in an appropriate place and in a safe manner, in accordance with
p.(None): the risk classification of human biological material, as well as maintaining the integrity of this material
p.(None): according to their specificities.
p.(None): Art. 36. The recipient must check and record the conditions for receiving biological material,
p.(None): communicating to the sender your arrival and the observed non-conformities.
p.(None): Single paragraph. The identification of the professional responsible for receiving must be recorded
p.(None): of the packaging containing the transported human biological material.
p.(None): Section IV
p.(None): Biosafety
p.(None): Art. 37. The transport of human biological material must comply with the rules of biosafety and health of the
p.(None): in order to prevent risks of direct exposure of the professionals involved,
p.(None): transporters, the population and the environment to human biological material.
p.(None): Art. 38. The personnel involved in the transportation process must have Collective Protection Equipment
p.(None): (EPC) and Personal Protective Equipment (PPE), according to the risk involved in handling activities
p.(None): Biological material.
p.(None): Art. 39. The carrier must carry out and maintain updated records of the training of the personnel involved in the process
p.(None): of transport for the correct use of the necessary equipment in situations of emergency, accident or breakdown.
p.(None): Art. 40. All personnel involved in the transport process at risk of direct exposure to human biological material
p.(None): must be vaccinated in accordance with worker health standards.
p.(None): Single paragraph. For the purposes of this Resolution, a professional is considered at risk of direct exposure to
p.(None): human biological material is one that has among its attributions the possibility of manipulating the internal content of the
p.(None): cargo transported.
p.(None): Art. 41. In the event of an accident, breakdown or other fact that exposes the carrier, the population or the environment to the risk of
p.(None): human biological material during transit, the carrier must take the following measures:
p.(None): I- inform the competent local authorities about the fact; II- inform the sender and the recipient of the event;
p.(None): III - dispose of the waste generated according to the information provided by the sender and other
p.(None): protection of the population and the environment, when applicable;
p.(None): IV- document, register and file the measures adopted.
p.(None): CHAPTER VI
p.(None): OF THE FINAL AND TRANSITIONAL PROVISIONS
p.(None): Art. 42. The documentation related to the sending, transport and receipt of human biological material must be
p.(None): filed for at least 5 (five) years or according to specific legislation for each type of material
p.(None): human biological.
p.(None): Art. 43. In addition to the provisions of this Resolution, the transport of human biological material must be
p.(None): carried out in accordance with the applicable legislation of other bodies and entities, including:
p.(None): I- Ministries of Transport (MT);
p.(None): II - National Land Transport Agency (ANTT), in the case of land transport; III - National Agency for
p.(None): Civil Aviation (ANAC), in the case of air transport;
p.(None): IV - National Waterway Transportation Agency (ANTAQ), in the case of waterway transportation.
...
Social / Soldier
Searching for indicator armedXforces:
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p.(None): be transported.
p.(None): §1 ° The outsourced service provider must be legally constituted and licensed by the supervisory body
p.(None): competent local health authority, pursuant to this Resolution and the federal, state and federal health surveillance rules
p.(None): relevant municipalities.
p.(None): §2 ° The outsourced service provider must have infrastructure, knowledge and adequate training of personnel,
p.(None): under the technical supervision of a professional proven to be able to perform the service satisfactorily
p.(None): requested by the contractor and meet the requirements
p.(None): technical and legal requirements established in this Resolution, without prejudice to the provisions of other rules in force
p.(None): peculiar to each biological material and mode of transport.
p.(None): §3 ° The written instrument that proves the outsourcing must be kept at the disposal of the authorities of
p.(None): competent health surveillance by the parties involved in the respective bilateral instrument.
p.(None): §4 ° Outsourcing of biological material transport activity does not exempt the health service
p.(None): sender of compliance with the technical and legal requirements established in the current legislation, responding
p.(None): jointly with the contractor before the health authorities regarding technical, operational and legal aspects
p.(None): inherent to the activities that they are responsible for.
p.(None): §5 ° In the event of transportation of human biological material, carried out by carriers or institutions
p.(None): government agencies, through authorized or established agreements between the Ministry of Health or a body or entity
p.(None): related, such as public security bodies and the Armed Forces, where licensing is not required
p.(None): health, the transport process can be assessed by the local health surveillance authorities
p.(None): competent if necessary.
p.(None): Article 8 - All documents and records of activities related to the transport of biological material
p.(None): they must be available for supply to the health surveillance bodies, whenever requested.
p.(None): Single paragraph. In the case of outsourced activity, it must be expressly stated in the written instrument that proves the
p.(None): outsourcing which documents and records should be kept by each party involved.
p.(None): Art. 9 The personnel directly involved in each stage of the transport process must receive regular training
p.(None): specific, compatible with the function performed and the nature of the material transported, and whenever it occurs
p.(None): change in procedures, and the effectiveness of this training should be periodically assessed.
p.(None): §1 ° The responsibilities for the preparation, execution and evaluation of the training must be defined in the instrument
p.(None): written document that proves outsourcing, according to the technical guidelines defined by the contractor,
p.(None): maintaining documentary records.
p.(None): §2 ° Whenever there is a change in the procedures, it must be ensured that the team is able to carry out the
p.(None): defined guidelines.
p.(None): §3 ° The provisions of the caput and in §§ 1 and 2 do not apply to the transport of tissues, cells and organs for the purpose of
p.(None): transplantation by transporters or government institutions, through an authorized or established agreement with the
p.(None): Ministry of Health or organ or institution that is part of the National Transplantation System, the sender being responsible, in this
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.(None): I - measures related to the shipping documentation required to transport biological material;
p.(None): II - adoption of biosafety measures;
p.(None): III - guarantee of the necessary conditions for the conservation and stability of biological material;
p.(None): IV - preparation of written instructions according to the activities developed by each party; and
p.(None): V - the definition of the logistics to be used and the communication mechanism between the parties involved.
p.(None): Single paragraph. For the international transport of human biological material, the
p.(None): responsibility for the documentation to be obtained rests with the importer / exporter.
p.(None): Sender Section I
p.(None): Art. 27. The sender must ensure compliance with the requirements provided for in this Resolution, without
p.(None): prejudice to the provisions of other current norms peculiar to each material and mode of transport, for the
p.(None): transport of human biological material, with due advance in relation to the respective air, land or
p.(None): waterway.
p.(None): Art. 28. The sender is responsible for the safe packaging of the material to be transported according to its type
p.(None): and classification.
p.(None): Single paragraph. The identification of the professional who stored the biological material for
p.(None): transport.
p.(None): Art. 29. The sender must provide those involved in the transportation process with technical information regarding the
p.(None): transported material, including procedures and care for the material, biological risk and
p.(None): emergency to be adopted in the event of an accident or fact that exposes the carrier, the population or the environment to
p.(None): human biological material.
p.(None): § 1 In the event that the sender uses the transport company service in his transport process
p.(None): road, rail, waterway or air operator passengers and cargo, which are not subject to the
p.(None): health licensing, the sender will be responsible for verifying the technical conditions under which
p.(None): this part of the process will be carried out and monitoring the delivery and arrival of the material at its destination
p.(None): by means of a written instrument proving outsourcing, without prejudice to the provisions of other
p.(None): current rules peculiar to each material and mode of transport.
p.(None): § 2 The competent health authority may assess, when deemed necessary, the technical health conditions of the
p.(None): transport of human biological material referred to in § 1 °.
p.(None): Art. 30. The sender must inform the recipient about specific information regarding the
p.(None): transportation, the date and the estimated time of arrival at the destination, when applicable, as established in
p.(None): written instrument that proves the relationship between the parties, so that the cargo can be received promptly.
p.(None): Section II
p.(None): From Carrier
p.(None): Art. 31. The carrier must guarantee the necessary infrastructure for the process of transporting biological material
p.(None): considering the respective type and risk classification.
p.(None): Art. 32. During the transportation of human biological material, the carrier must carry a document that
p.(None): allow the traceability of the shipment / cargo transported.
...
p.(None): mechanism that ensures the integrity of the tertiary packaging and the biological material transported.
p.(None): Section III Of the Recipient
p.(None): Art. 35. The recipient must guarantee the opening of the packages in an appropriate place and in a safe manner, in accordance with
p.(None): the risk classification of human biological material, as well as maintaining the integrity of this material
p.(None): according to their specificities.
p.(None): Art. 36. The recipient must check and record the conditions for receiving biological material,
p.(None): communicating to the sender your arrival and the observed non-conformities.
p.(None): Single paragraph. The identification of the professional responsible for receiving must be recorded
p.(None): of the packaging containing the transported human biological material.
p.(None): Section IV
p.(None): Biosafety
p.(None): Art. 37. The transport of human biological material must comply with the rules of biosafety and health of the
p.(None): in order to prevent risks of direct exposure of the professionals involved,
p.(None): transporters, the population and the environment to human biological material.
p.(None): Art. 38. The personnel involved in the transportation process must have Collective Protection Equipment
p.(None): (EPC) and Personal Protective Equipment (PPE), according to the risk involved in handling activities
p.(None): Biological material.
p.(None): Art. 39. The carrier must carry out and maintain updated records of the training of the personnel involved in the process
p.(None): of transport for the correct use of the necessary equipment in situations of emergency, accident or breakdown.
p.(None): Art. 40. All personnel involved in the transport process at risk of direct exposure to human biological material
p.(None): must be vaccinated in accordance with worker health standards.
p.(None): Single paragraph. For the purposes of this Resolution, a professional is considered at risk of direct exposure to
p.(None): human biological material is one that has among its attributions the possibility of manipulating the internal content of the
p.(None): cargo transported.
p.(None): Art. 41. In the event of an accident, breakdown or other fact that exposes the carrier, the population or the environment to the risk of
p.(None): human biological material during transit, the carrier must take the following measures:
p.(None): I- inform the competent local authorities about the fact; II- inform the sender and the recipient of the event;
p.(None): III - dispose of the waste generated according to the information provided by the sender and other
p.(None): protection of the population and the environment, when applicable;
p.(None): IV- document, register and file the measures adopted.
p.(None): CHAPTER VI
p.(None): OF THE FINAL AND TRANSITIONAL PROVISIONS
p.(None): Art. 42. The documentation related to the sending, transport and receipt of human biological material must be
p.(None): filed for at least 5 (five) years or according to specific legislation for each type of material
p.(None): human biological.
p.(None): Art. 43. In addition to the provisions of this Resolution, the transport of human biological material must be
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): and monitoring of biological material transport processes;
p.(None): XIX - transporter: natural or legal person who transports human biological material
p.(None): from a sender to a specified recipient including commercial, public or
p.(None): private and self-loading;
p.(None): XX - validation: set of actions used to prove that operational procedures, processes,
p.(None): activities or systems produce the expected result with exercises conducted according to protocols previously
p.(None): defined and approved, with description of tests and acceptance criteria.
p.(None): CHAPTER II
p.(None): INITIAL PROVISIONS
p.(None): Art. 4 The transportation of human biological material is subject to the established rules and procedures
p.(None): in this Resolution, without prejudice to the provisions of other current rules specific to each material and mode of transport.
p.(None): Art. 5 The transport operations must be registered and standardized through updated written instructions.
p.(None): Single paragraph. Standardized written instructions should be available to all personnel involved in the
p.(None): transportation process and be reviewed annually and / or whenever changes in procedures occur.
p.(None): Art. 6 Any non-conformities during the transportation process must be investigated and registered,
p.(None): including, where applicable, the corrective and preventive measures adopted.
p.(None): Art. 7 The transport of human biological material can be carried out on an outsourced basis, through
p.(None): written instrument that proves the outsourcing, obeying the specifications of the human biological material to
p.(None): be transported.
p.(None): §1 ° The outsourced service provider must be legally constituted and licensed by the supervisory body
p.(None): competent local health authority, pursuant to this Resolution and the federal, state and federal health surveillance rules
p.(None): relevant municipalities.
p.(None): §2 ° The outsourced service provider must have infrastructure, knowledge and adequate training of personnel,
p.(None): under the technical supervision of a professional proven to be able to perform the service satisfactorily
p.(None): requested by the contractor and meet the requirements
p.(None): technical and legal requirements established in this Resolution, without prejudice to the provisions of other rules in force
p.(None): peculiar to each biological material and mode of transport.
p.(None): §3 ° The written instrument that proves the outsourcing must be kept at the disposal of the authorities of
p.(None): competent health surveillance by the parties involved in the respective bilateral instrument.
p.(None): §4 ° Outsourcing of biological material transport activity does not exempt the health service
p.(None): sender of compliance with the technical and legal requirements established in the current legislation, responding
p.(None): jointly with the contractor before the health authorities regarding technical, operational and legal aspects
p.(None): inherent to the activities that they are responsible for.
p.(None): §5 ° In the event of transportation of human biological material, carried out by carriers or institutions
p.(None): government agencies, through authorized or established agreements between the Ministry of Health or a body or entity
p.(None): related, such as public security bodies and the Armed Forces, where licensing is not required
p.(None): health, the transport process can be assessed by the local health surveillance authorities
p.(None): competent if necessary.
p.(None): Article 8 - All documents and records of activities related to the transport of biological material
...
p.(None): Art. 27. The sender must ensure compliance with the requirements provided for in this Resolution, without
p.(None): prejudice to the provisions of other current norms peculiar to each material and mode of transport, for the
p.(None): transport of human biological material, with due advance in relation to the respective air, land or
p.(None): waterway.
p.(None): Art. 28. The sender is responsible for the safe packaging of the material to be transported according to its type
p.(None): and classification.
p.(None): Single paragraph. The identification of the professional who stored the biological material for
p.(None): transport.
p.(None): Art. 29. The sender must provide those involved in the transportation process with technical information regarding the
p.(None): transported material, including procedures and care for the material, biological risk and
p.(None): emergency to be adopted in the event of an accident or fact that exposes the carrier, the population or the environment to
p.(None): human biological material.
p.(None): § 1 In the event that the sender uses the transport company service in his transport process
p.(None): road, rail, waterway or air operator passengers and cargo, which are not subject to the
p.(None): health licensing, the sender will be responsible for verifying the technical conditions under which
p.(None): this part of the process will be carried out and monitoring the delivery and arrival of the material at its destination
p.(None): by means of a written instrument proving outsourcing, without prejudice to the provisions of other
p.(None): current rules peculiar to each material and mode of transport.
p.(None): § 2 The competent health authority may assess, when deemed necessary, the technical health conditions of the
p.(None): transport of human biological material referred to in § 1 °.
p.(None): Art. 30. The sender must inform the recipient about specific information regarding the
p.(None): transportation, the date and the estimated time of arrival at the destination, when applicable, as established in
p.(None): written instrument that proves the relationship between the parties, so that the cargo can be received promptly.
p.(None): Section II
p.(None): From Carrier
p.(None): Art. 31. The carrier must guarantee the necessary infrastructure for the process of transporting biological material
p.(None): considering the respective type and risk classification.
p.(None): Art. 32. During the transportation of human biological material, the carrier must carry a document that
p.(None): allow the traceability of the shipment / cargo transported.
p.(None): Art. 33. The carrier must check the packaging and documentation conditions upon receipt of the material
p.(None): for the transport of human biological material and contact the sender, in case of finding
p.(None): any non-conformity in the packaging and / or documentation, for taking corrective measures applicable in time
p.(None): skilled for transportation.
p.(None): Art. 34. The transport vehicle must have adequate hygiene and cleaning conditions, as well as have
p.(None): mechanism that ensures the integrity of the tertiary packaging and the biological material transported.
p.(None): Section III Of the Recipient
p.(None): Art. 35. The recipient must guarantee the opening of the packages in an appropriate place and in a safe manner, in accordance with
p.(None): the risk classification of human biological material, as well as maintaining the integrity of this material
...
p.(None): CHAPTER VI
p.(None): OF THE FINAL AND TRANSITIONAL PROVISIONS
p.(None): Art. 42. The documentation related to the sending, transport and receipt of human biological material must be
p.(None): filed for at least 5 (five) years or according to specific legislation for each type of material
p.(None): human biological.
p.(None): Art. 43. In addition to the provisions of this Resolution, the transport of human biological material must be
p.(None): carried out in accordance with the applicable legislation of other bodies and entities, including:
p.(None): I- Ministries of Transport (MT);
p.(None): II - National Land Transport Agency (ANTT), in the case of land transport; III - National Agency for
p.(None): Civil Aviation (ANAC), in the case of air transport;
p.(None): IV - National Waterway Transportation Agency (ANTAQ), in the case of waterway transportation.
p.(None): Art. 44. The health services and carriers of biological material covered by this Resolution will have
p.(None): the period of 30 (thirty) days from the date of its publication to promote the adjustments
p.(None): necessary for its fulfillment.
p.(None): Art. 45. New carriers of biological material and those who intend to restart their activities must attend
p.(None): to the requirements of this Resolution, from its publication, prior to its beginning of operation.
p.(None): Art. 46. Failure to comply with the provisions contained in this Resolution constitutes a sanitary infraction, in
p.(None): terms of Law No. 6,437, of August 20, 1977, without prejudice to civil liabilities,
p.(None): administrative and criminal penalties.
p.(None): Art. 47. The omitted or exceptional cases verified in the application of this norm will be considered by the
p.(None): competent health surveillance authority under current legislation.
p.(None): Art. 48. This Resolution of the Collegiate Board takes effect on the date of its publication.
p.(None): IVO BUCARESKY
p.(None): ATTACHMENT
p.(None): RISK CLASSIFICATION APPLIED TO THE TRANSPORT OF HUMAN BIOLOGICAL MATERIAL
p.(None): Human biological sample
p.(None): 1- Is it known that the sample does not contain infectious agents?
p.(None): 2- Has the biological material been subjected to processes of neutralization or inactivation of infectious agents?
p.(None): 3- Does biological material contain only microorganisms not pathogenic to humans?
p.(None): 4- Is it a dry blood sample in absorbent material or similar?
p.(None): 5- Is it biological material for therapeutic purposes in transfusion / transplantation?
p.(None): They are not subject to the transportation regulations for dangerous articles in force. Exempt biological material.
p.(None): Check specific regulations according to each material and transport purpose
p.(None): YES NO or NO KNOWS
p.(None): Can it be classified as Category A Biological Material?
p.(None): Yes or no
p.(None): DO NOT KNOW
p.(None): Infectious Substance Category A
p.(None): Biological sample with MINIMUM probability of the presence of infectious agents
p.(None): YES NO or NO
p.(None): IF YOU KNOW
p.(None): Minimum Risk Human Specimen
p.(None): Biological Substance Category B
p.(None): Adapted:
p.(None): 1) WHO - World Health Organization
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| armedXforces | Soldier |
| authority | Relationship to Authority |
| criminal | criminal |
| emergency | Public Emergency |
| language | Linguistic Proficiency |
| party | political affiliation |
| single | Marital Status |
| substance | Drug Usage |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input