Title: RDC Resolution No. 20, of April 10, 2014
Menu: Provides for health regulations for the transport of human biological material.
Publication: D.O.U - Federal Official Gazette; Executive Branch, of April 11, 2014
Issuing Agency: Anvisa - National Health Surveillance Agency
Scope of the act: Federal - Brazil
Practice Area: Blood, other Tissues, Cells and Organs
Resolution of the Collegiate Board - RDC nº 20, of April 10, 2014
Provides for health regulations for the transport of human biological material.
The Collegiate Directorate of the National Health Surveillance Agency, in the use of the powers conferred on it by the items
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
Internal Regulation approved pursuant to Annex I of ANVISA Ordinance No. 354, of August 11, 2006,
republished in the DOU of August 21, 2006, and its updates, in view of the provisions of items III, of art. 2nd,
III and IV, of article 7 of Law 9.782, of 1999, and the Program for Improvement of the Regulatory Process of the
Agency, established through Ordinance No. 422, of April 16, 2008, in a meeting held in
March 25, 2014, adopts the following Resolution of the Collegiate Board and I, the Chief Executive Officer
Substitute, I determine its publication:
CHAPTER I
INITIAL PROVISIONS
Section I Purpose
Art. 1 This Resolution has the objective of defining and establishing sanitary standards for the transportation of
biological material of human origin in its different modalities and forms, without prejudice to the provisions of other
current rules peculiar to each material and mode of transport, to ensure safety, minimize risks
sanitary conditions and preserve the integrity of the material transported.
Section II Scope
Art. 2 This Resolution applies to all sender, carrier, recipient and others involved in the
transport process of human biological material, without prejudice to the provisions of other current norms peculiar to
each material and mode of transport.
Single paragraph. The provisions of this Resolution apply as applicable, to import and export procedures
export of human biological material, without prejudice to the provisions of other current norms peculiar to each
material and mode of transport.
Section III Definitions
Art. 3 For the purposes of this Resolution, the following definitions are adopted:
I - packaging of human biological material: procedure for packaging human biological material with the
purpose of transportation, aiming at the protection of material, people and the environment during all stages of the
transportation to its final destination;
II - Category A: infectious biological material whose exposure may cause disability
permanent or deadly disease, endangering human or other animal life flagged as UN 2814 or UN 2900
if it affects only animals.
III - Category B: infectious biological material not included in category A, classified as "substance
biological test "Category B" UN 3373, inserting into this group samples of patients that are suspected or
know how to contain infectious agents that cause disease in humans;
IV - Minimum Specimen Human Specimen Category: adapted from English "Exempt Human Specimen", includes
biological materials from healthy individuals who have been subjected to professional judgment based on
clinical history, symptoms and individual characteristics, as well as local endemic conditions that
ensure the minimum likelihood of biological material containing pathogenic microorganisms, even if these
materials have not previously been tested for markers of communicable disease by the
blood, following the guidelines of the World Health Organization (WHO);
V - biological risk classification: level of risk in relation to exposure to biological agents, determined
by pathogenesis, mode, relative ease of transmission through biological materials and
reversibility of the disease due to the availability of known and effective treatments and preventives;
VI - recipient: any legal person, public or private, responsible for receiving
the human biological material transported;
VII - primary packaging: packaging that is in direct contact with the biological material to be transported,
constituting a container, wrap or any other form of protection, removable or not, which is intended
to fill, maintain, contain, cover or package the biological material to be transported, also called
inner packaging;
VIII - secondary packaging: intermediate packaging, placed between the primary packaging and the tertiary packaging, with
purposes of containing primary packaging;
IX - tertiary packaging: external packaging, used exclusively for cargo protection in operations
handling (loading, unloading and transportation) and storage;
X - label: identification affixed to the label, without erasures and that does not compromise the information
label originals;
XI - absorbent material: material placed between the primary and secondary packaging in quantity
enough to contain the entire content of biological material in the primary packaging ensuring the integrity of the
tertiary packaging;
XII - human biological material: tissue or fluid constituting the human organism, such as excrement, fluids
bodily, cells, tissues, organs or other fluids of human origin or isolated from them;
XIII - refrigerant material: material or substance capable of conserving biological material in a range of
temperature, previously specified, during the transport process;
XIV - mode of transport: mechanism, alternative or type of transport vehicle used to move the material
human biological;
XV - sender: any legal person, of a public or private nature, also called a sender or
shipper, responsible for preparing and sending human biological material to a recipient,
transport;
XVI - labeling: procedure for labeling, marking and labeling packages intended for the transport of
human biological material;
XVII - label: corresponds to the printed or lithographed identification and the words painted or engraved on
fire, pressure or self-adhesive, applied directly on containers, packaging, wrappers, wraps,
cartridges and any other packaging protector and cannot be removed or altered during transportation and
storage;
XVIII - technical supervisor: trained and designated professional to perform the activities of implementation, execution
and monitoring of biological material transport processes;
XIX - transporter: natural or legal person who transports human biological material
from a sender to a specified recipient including commercial, public or
private and self-loading;
XX - validation: set of actions used to prove that operational procedures, processes,
activities or systems produce the expected result with exercises conducted according to protocols previously
defined and approved, with description of tests and acceptance criteria.
CHAPTER II
INITIAL PROVISIONS
Art. 4 The transportation of human biological material is subject to the established rules and procedures
in this Resolution, without prejudice to the provisions of other current rules specific to each material and mode of transport.
Art. 5 The transport operations must be registered and standardized through updated written instructions.
Single paragraph. Standardized written instructions should be available to all personnel involved in the
transportation process and be reviewed annually and / or whenever changes in procedures occur.
Art. 6 Any non-conformities during the transportation process must be investigated and registered,
including, where applicable, the corrective and preventive measures adopted.
Art. 7 The transport of human biological material can be carried out on an outsourced basis, through
written instrument that proves the outsourcing, obeying the specifications of the human biological material to
be transported.
§1 ° The outsourced service provider must be legally constituted and licensed by the supervisory body
competent local health authority, pursuant to this Resolution and the federal, state and federal health surveillance rules
relevant municipalities.
§2 ° The outsourced service provider must have infrastructure, knowledge and adequate training of personnel,
under the technical supervision of a professional proven to be able to perform the service satisfactorily
requested by the contractor and meet the requirements
technical and legal requirements established in this Resolution, without prejudice to the provisions of other rules in force
peculiar to each biological material and mode of transport.
§3 ° The written instrument that proves the outsourcing must be kept at the disposal of the authorities of
competent health surveillance by the parties involved in the respective bilateral instrument.
§4 ° Outsourcing of biological material transport activity does not exempt the health service
sender of compliance with the technical and legal requirements established in the current legislation, responding
jointly with the contractor before the health authorities regarding technical, operational and legal aspects
inherent to the activities that they are responsible for.
§5 ° In the event of transportation of human biological material, carried out by carriers or institutions
government agencies, through authorized or established agreements between the Ministry of Health or a body or entity
related, such as public security bodies and the Armed Forces, where licensing is not required
health, the transport process can be assessed by the local health surveillance authorities
competent if necessary.
Article 8 - All documents and records of activities related to the transport of biological material
they must be available for supply to the health surveillance bodies, whenever requested.
Single paragraph. In the case of outsourced activity, it must be expressly stated in the written instrument that proves the
outsourcing which documents and records should be kept by each party involved.
Art. 9 The personnel directly involved in each stage of the transport process must receive regular training
specific, compatible with the function performed and the nature of the material transported, and whenever it occurs
change in procedures, and the effectiveness of this training should be periodically assessed.
§1 ° The responsibilities for the preparation, execution and evaluation of the training must be defined in the instrument
written document that proves outsourcing, according to the technical guidelines defined by the contractor,
maintaining documentary records.
§2 ° Whenever there is a change in the procedures, it must be ensured that the team is able to carry out the
defined guidelines.
§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
transplantation by transporters or government institutions, through an authorized or established agreement with the
Ministry of Health or organ or institution that is part of the National Transplantation System, the sender being responsible, in this
case, comply with the provisions of art. 29 of this Resolution.
CHAPTER III
PACKAGING AND PACKAGING
Art. 10. The human biological material to be transported must be packaged in such a way as to preserve its
integrity and stability, as well as the safety of the personnel involved, during the transport process.
Art. 11 The biological material conditioning step must be validated, considering the
type of biological material and the purpose of transport, with approval by the responsible technical supervisor
by conditioning the biological material to be transported.
§1 ° If temperature control is necessary, this parameter must be considered in the process of
transport validation, in order to guarantee conservation of biological characteristics for the duration of
planned transport, with estimated delay margin.
§2 ° Any changes in packaging and packaging operations and technical characteristics defined in
validation will be evaluated by the technical supervisor as to the need for revalidation, keeping the records
documentary.
Art. 12. The packaging system must be used according to the specificities of the biological material transported.
Single paragraph. The packaging referred to in the caput must be used exclusively for transportation purposes
and made up of appropriate material, in accordance with the provisions of this Resolution, without prejudice to the
other current norms peculiar to each material and mode of transport and, in the alternative, in the instructions of the
packaging manufacturer.
Art. 13. For human biological material classified as an infectious substance Category A UN 2814 must be
the current normative provisions regarding the PI 620 packaging instruction are applied, without prejudice to the
other regulations in force specific to each material and mode of transport.
Art. 14. For human biological material classified as Category B UN 3373 biological substance, the following must be
the current normative provisions regarding the PI 650 packaging instruction are applied, without prejudice to the
other regulations in force specific to each material and mode of transport.
Art. 15. For the Human Specimen Category of Minimum Risk, the following minimum requirements must be applied
without prejudice to the provisions of other current norms peculiar to each material and method of
transport:
I - primary packaging, equipped with a device that guarantees leak-proof and impermeable sealing for
liquid samples, and in the case of solid or semi-solid samples, resistant container with
closure that prevents the material from overflowing.
II - rigid, resistant tertiary packaging, of adequate size to the biological material transported, and
equipped with a closing device, observing that washable and resistant to disinfectant materials can
be reusable.
III - secondary packaging of resistant material in order to contain the primary packaging, leak-proof.
Single paragraph. For biological samples transported in fragile, breakable inner packaging,
hole or crack, it is necessary to observe the following aspects:
a) the primary packaging (s) must be arranged in such a way as to avoid shocks between them and / or
with the packaging that
(s) involves, in order to maintain the integrity of the material transported; and
b) for liquid samples, absorbent material must be used as part of the packaging system.
in order to absorb the entire contents of the primary packaging (s) in the event of material overflow.
Art. 16. For human biological material that does not fall under the classifications of articles 13, 14 and 15 and that
are known to be free of infectious agents, or have undergone
neutralization / inactivation, which are dry biological materials
collected in specific devices, blood and components for transfusion, cells, tissues and organs for
transplantation, the provisions of article 15 shall apply for packaging procedures, without prejudice to the
other regulations in force specific to each material and mode of transport.
Art. 17. To classify the human biological material to be transported, use the diagram of
risk classification applied to the transport of human biological material according to the guidelines of the
World Health Organization (WHO), in accordance with the Annex to this Resolution, without prejudice to the provisions of other
current norms peculiar to each material and mode of transport.
Art. 18. In the case of the use of overpacking mechanisms for packaging of packages, it must be ensured
that each package is correctly labeled and signaled, in accordance with the provisions of this Resolution, without
prejudice to the provisions of other current rules peculiar to each material and mode of transport.
Art. 19. Only packages made of materials that can be cleaned, dried and disinfected or
sterilization, if technically justified, can be reused, through defined protocols and
maintaining records of procedures performed.
CHAPTER IV LABELING
Art. 20. The labeling must be in accordance with the type, risk classification and
conservation of human biological material transported.
Art. 21. The information contained in the label and the label must be legible, understandable, expressed in language
Portuguese with indelible ink, waterproof and on a background of contrasting color, with proportional dimensions to the
size of the packaging, without prejudice to the provisions of other current norms peculiar to each material and method of
transport.
Sole paragraph: In the case of importation of biological material, the information expressed in Portuguese
or English language.
Art. 22. The label and the label must remain firmly adhered to the packaging, and cannot be
streaked, tampered with or covered by labels, marks or packaging parts.
Art. 23. The tertiary packaging must contain, at least, without prejudice to the provisions of other current rules
peculiar to each material and mode of transport:
I - identification of the sender and recipient, in addition to full addresses and contact telephone numbers;
II - appropriate identification of biological material;
III- label and marking referring to the type of biological material transported, when applicable; IV- phrases of
warnings, when applicable;
V- signaling of the mode and direction of opening, when applicable; VI- marking of approved packaging, when applicable
and;
VII- telephone contacts, available 24 (twenty four) hours, for cases of accidents and incidents.
§1 ° The infectious human biological material classified as Category A or Category B must be
transported in packaging labeled according to specific rules for air, land and
waterway regulations.
§2 ° All human biological material classified as Category A must contain in the tertiary transport packaging, the
biohazard label according to specific rules for air, land and water transport
in force.
Art. 24. For transportation that contains dry ice, liquid nitrogen, cryogenic liquid, non-flammable gas
or other conservation and preservation material that poses risks during the transportation process, the
packaging and signage must be in accordance with current regulations peculiar to the transportation of material considered
dangerous.
Art. 25. When dealing with human biological material that cannot be subjected to radiation (X-rays), as
characteristic must be clearly indicated on the tertiary packaging.
CHAPTER V
RESPONSIBILITIES
Art. 26. The responsibilities of the sender, carrier and recipient must be defined and documented
written instrument covering, at the stage of the transport process that is appropriate:
I - measures related to the shipping documentation required to transport biological material;
II - adoption of biosafety measures;
III - guarantee of the necessary conditions for the conservation and stability of biological material;
IV - preparation of written instructions according to the activities developed by each party; and
V - the definition of the logistics to be used and the communication mechanism between the parties involved.
Single paragraph. For the international transport of human biological material, the
responsibility for the documentation to be obtained rests with the importer / exporter.
Sender Section I
Art. 27. The sender must ensure compliance with the requirements provided for in this Resolution, without
prejudice to the provisions of other current norms peculiar to each material and mode of transport, for the
transport of human biological material, with due advance in relation to the respective air, land or
waterway.
Art. 28. The sender is responsible for the safe packaging of the material to be transported according to its type
and classification.
Single paragraph. The identification of the professional who stored the biological material for
transport.
Art. 29. The sender must provide those involved in the transportation process with technical information regarding the
transported material, including procedures and care for the material, biological risk and
emergency to be adopted in the event of an accident or fact that exposes the carrier, the population or the environment to
human biological material.
§ 1 In the event that the sender uses the transport company service in his transport process
road, rail, waterway or air operator passengers and cargo, which are not subject to the
health licensing, the sender will be responsible for verifying the technical conditions under which
this part of the process will be carried out and monitoring the delivery and arrival of the material at its destination
by means of a written instrument proving outsourcing, without prejudice to the provisions of other
current rules peculiar to each material and mode of transport.
§ 2 The competent health authority may assess, when deemed necessary, the technical health conditions of the
transport of human biological material referred to in § 1 °.
Art. 30. The sender must inform the recipient about specific information regarding the
transportation, the date and the estimated time of arrival at the destination, when applicable, as established in
written instrument that proves the relationship between the parties, so that the cargo can be received promptly.
Section II
From Carrier
Art. 31. The carrier must guarantee the necessary infrastructure for the process of transporting biological material
considering the respective type and risk classification.
Art. 32. During the transportation of human biological material, the carrier must carry a document that
allow the traceability of the shipment / cargo transported.
Art. 33. The carrier must check the packaging and documentation conditions upon receipt of the material
for the transport of human biological material and contact the sender, in case of finding
any non-conformity in the packaging and / or documentation, for taking corrective measures applicable in time
skilled for transportation.
Art. 34. The transport vehicle must have adequate hygiene and cleaning conditions, as well as have
mechanism that ensures the integrity of the tertiary packaging and the biological material transported.
Section III Of the Recipient
Art. 35. The recipient must guarantee the opening of the packages in an appropriate place and in a safe manner, in accordance with
the risk classification of human biological material, as well as maintaining the integrity of this material
according to their specificities.
Art. 36. The recipient must check and record the conditions for receiving biological material,
communicating to the sender your arrival and the observed non-conformities.
Single paragraph. The identification of the professional responsible for receiving must be recorded
of the packaging containing the transported human biological material.
Section IV
Biosafety
Art. 37. The transport of human biological material must comply with the rules of biosafety and health of the
in order to prevent risks of direct exposure of the professionals involved,
transporters, the population and the environment to human biological material.
Art. 38. The personnel involved in the transportation process must have Collective Protection Equipment
(EPC) and Personal Protective Equipment (PPE), according to the risk involved in handling activities
Biological material.
Art. 39. The carrier must carry out and maintain updated records of the training of the personnel involved in the process
of transport for the correct use of the necessary equipment in situations of emergency, accident or breakdown.
Art. 40. All personnel involved in the transport process at risk of direct exposure to human biological material
must be vaccinated in accordance with worker health standards.
Single paragraph. For the purposes of this Resolution, a professional is considered at risk of direct exposure to
human biological material is one that has among its attributions the possibility of manipulating the internal content of the
cargo transported.
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
human biological material during transit, the carrier must take the following measures:
I- inform the competent local authorities about the fact; II- inform the sender and the recipient of the event;
III - dispose of the waste generated according to the information provided by the sender and other
protection of the population and the environment, when applicable;
IV- document, register and file the measures adopted.
CHAPTER VI
OF THE FINAL AND TRANSITIONAL PROVISIONS
Art. 42. The documentation related to the sending, transport and receipt of human biological material must be
filed for at least 5 (five) years or according to specific legislation for each type of material
human biological.
Art. 43. In addition to the provisions of this Resolution, the transport of human biological material must be
carried out in accordance with the applicable legislation of other bodies and entities, including:
I- Ministries of Transport (MT);
II - National Land Transport Agency (ANTT), in the case of land transport; III - National Agency for
Civil Aviation (ANAC), in the case of air transport;
IV - National Waterway Transportation Agency (ANTAQ), in the case of waterway transportation.
Art. 44. The health services and carriers of biological material covered by this Resolution will have
the period of 30 (thirty) days from the date of its publication to promote the adjustments
necessary for its fulfillment.
Art. 45. New carriers of biological material and those who intend to restart their activities must attend
to the requirements of this Resolution, from its publication, prior to its beginning of operation.
Art. 46. Failure to comply with the provisions contained in this Resolution constitutes a sanitary infraction, in
terms of Law No. 6,437, of August 20, 1977, without prejudice to civil liabilities,
administrative and criminal penalties.
Art. 47. The omitted or exceptional cases verified in the application of this norm will be considered by the
competent health surveillance authority under current legislation.
Art. 48. This Resolution of the Collegiate Board takes effect on the date of its publication.
IVO BUCARESKY
ATTACHMENT
RISK CLASSIFICATION APPLIED TO THE TRANSPORT OF HUMAN BIOLOGICAL MATERIAL
Human biological sample
1- Is it known that the sample does not contain infectious agents?
2- Has the biological material been subjected to processes of neutralization or inactivation of infectious agents?
3- Does biological material contain only microorganisms not pathogenic to humans?
4- Is it a dry blood sample in absorbent material or similar?
5- Is it biological material for therapeutic purposes in transfusion / transplantation?
They are not subject to the transportation regulations for dangerous articles in force. Exempt biological material.
Check specific regulations according to each material and transport purpose
YES NO or NO KNOWS
Can it be classified as Category A Biological Material?
Yes or no
DO NOT KNOW
Infectious Substance Category A
Biological sample with MINIMUM probability of the presence of infectious agents
YES NO or NO
IF YOU KNOW
Minimum Risk Human Specimen
Biological Substance Category B
Adapted:
1) WHO - World Health Organization
Regulatory Guide for the Transport of Infectious Substances 2013 - 2014.