0A4F4F9BD490A749D5437F821CF06DF1

Regulation on Tissue Banks (2014)

https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=20005848

http://leaux.net/URLS/ConvertAPI Text Files/EE48B0337B8AE50BFE2BA713734672DC.en.txt

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This file was generated: 2020-07-14 06:32:49

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

Vulnerability Type	Vulnerability	Indicator	# Matches
Health	Motherhood/Family	family	1
Social	Access to Social Goods	access	2
Social	Age	age	1
Social	Marital Status	single	3
Social	Occupation	job	1
Social	Property Ownership	home	1
Social	Trade Union Membership	union	1
Social	Youth/Minors	youth	1
Social	employees	employees	2
Social	gender	gender	1
General/Other	Natural Hazards	hazard	2
General/Other	Public Emergency	emergency	1

Health / Motherhood/Family

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p.(None): Home Contact Sitemap Imprint Deutsch
p.(None): [Federal law] State law Municipal law Judiciary Other announcements, decrees Total query
p.(None): Federal law consolidated: Entire legal provision for tissue banking regulation, version dated February 19, 2020 Print view
p.(None): Other formats:
p.(None): long Title
p.(None): Ordinance of the Federal Minister for Health, Family and Youth, with which more detailed regulations for the operation of tissue banks are made
p.(None): (Tissue Bank Ordinance - GBVO)
p.(None): StF: BGBl. II No. 192/2008 [CELEX-No .: 32006L0017, 32006L0086]
p.(None): modification
p.(None): BGBl. II No. 87/2014 [CELEX-No .: 32012L0039]
p.(None): BGBl. II No. 18/2017 [CELEX-No .: 32015L0565]
p.(None): Preamble / Promulgatory
p.(None): On the basis of Section 30 of the Tissue Safety Act, Federal Law Gazette I No. 49/2008, the following is prescribed:
p.(None): text
p.(None): scope
p.(None): Section 1. (1) This Ordinance applies to the operation of tissue banks in accordance with Section 2 (15) of the Tissue Security Act (GSG), Federal Law Gazette I No. 49/2008.
p.(None): (2) The General Employee Protection Ordinance, BGBl. № 218/1983, last amended by the Ordinance BGBl. II № 77/2007, and the Ordinance
p.(None): biological agents, Federal Law Gazette II No. 237/1998, are not affected by this regulation.
p.(None): (3) The initial provisions of Section 2 of the Tissue Safety Act (GSG), Federal Law Gazette I No. 49/2008, and Section 1 of the Tissue Removal Equipment Ordinance,
p.(None): BGBl. II No. 191/2008, each in the current version, also apply to this regulation.
p.(None): quality system
p.(None): § 2. (1) The quality management of tissue banks includes all coordinated activities related to the management and control of a tissue bank
p.(None): Quality at all levels.
p.(None): (2) Quality is to be striven for by everyone involved in the work processes of the tissue bank, with the management and the responsible
p.(None): Ensure a systematic quality standard and the introduction and maintenance of a quality system according to § 9 GSG
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p.(None): a bacterial or fungal infection on the recipient than in cell or tissue transplantation, or
p.(None): 3. It is not technically possible to carry out the required process in a level A environment.
p.(None): The environmental conditions must be specified. It must be demonstrated and documented that the required quality and the required environment
p.(None): Safety of the cells or tissues can be achieved, this taking into account the intended purpose, the type of use and
p.(None): if applicable, the immune status of the recipient.
p.(None): (5) Written hygiene and clothing regulations must be laid down for all work rooms and warehouses.
p.(None): (6) Suitable clothing and equipment for personal protection and hygiene must be provided in all work and storage rooms of the tissue bank.
p.(None): (7) For the storage of cells and tissues, the storage conditions including relevant parameters such as temperature, humidity or
p.(None): Air quality, which are necessary to maintain the required properties of the cells and tissues. Critical parameters are too
p.(None): inspect, monitor and record to demonstrate that the specified storage conditions are met.
p.(None): (8) Storage facilities shall be provided which clearly separate cells and tissues which have not yet been released or
p.(None): distinguish between those that have been released and those that have been rejected to avoid confusion and cross-contamination. Spatially separated areas or
p.(None): Storage devices or the safe separation within the storage device are both in the quarantine and in the release storage area for
p.(None): to maintain certain tissues and cells according to specific criteria.
p.(None): (9) Tissue banks must have written instructions and procedures for access controls, cleaning and maintenance, waste disposal and
p.(None): the behavior in an emergency.
p.(None): equipment
p.(None): Section 5
p.(None): be available in sufficient numbers to ensure processing, storage and distribution that is state of the art. The
p.(None): Equipment must be selected in such a way that a hazard to the cells or tissues, the recipient and / or the personnel is excluded as far as possible or
p.(None): is reduced to the non-excluded minimum.
p.(None): (2) The equipment, which is critical with regard to the product quality, must be identified and qualified according to the intended use,
p.(None): undergo regular inspections and maintain according to the manufacturer's instructions. New and repaired equipment must be closed before commissioning
p.(None): testing. The test results must be documented.
p.(None): (3) If critical processing or storage parameters are affected by the equipment, these are to be determined and must be more appropriate
p.(None): Monitoring, warning, alarm or corrective measures, so that malfunctions and defects are identified and thus it is ensured that the
p.(None): critical parameters are kept within defined limits at all times. Maintenance, repair, cleaning, disinfection and decontamination
p.(None): All critical equipment must be carried out regularly and documented accordingly. There must be procedures for operating each part of the critical
p.(None): Equipment is available that details what action to take in the event of malfunction or failure.
p.(None): (4) Scales, weights and other measuring devices are last changed by the according to the measure and calibration law, Federal Law Gazette № 152/1950
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p.(None): § 7. (1) Tissue banks must have set up a system that ensures comprehensive and correct documentation for all activities. The system
p.(None): must ensure that all work steps are standardized and that all work steps, in particular with regard to acceptance, processing, storage,
p.(None): Transport, distribution or disposal, including aspects of quality control and quality assurance are comprehensible. The documents must be clear
p.(None): be clear, error-free and up to date and checked regularly.
p.(None): (2) For each critical activity, the appropriate materials and equipment, as well as the personnel involved, must be defined and documented.
p.(None): (3) All changes to documents must be checked, dated, approved, documented and immediately authorized personnel
p.(None): to implement. A document control procedure for the chronology of document reviews and changes must be set up, which ensures
p.(None): that only the current versions of the documents are used.
p.(None): (4) If documents are not recorded in writing, but with electronic, photographic or other data processing systems, the
p.(None): Tissue bank validate the system beforehand by demonstrating that the data is correct during the expected retention period
p.(None): be secured. These data stored with such systems must be made available in a legible form at all times and are therefore
p.(None): Submit to the Federal Office for Safety in Health Care on request. Electronically stored data must take appropriate measures such as duplication
p.(None): or backup and transfer to another storage system can be protected against data loss or damage. These measures must
p.(None): be understandable.
p.(None): (5) Without prejudice to Paragraph 6, all records, including raw data that are critical for the safety and quality of the tissues and cells, are subject to this condition
p.(None): document that access to this data is ensured at least ten years after the expiry date, clinical use or disposal
p.(None): is.
p.(None): (6) Tissue banks must store the data in accordance with the system in a suitable and readable data archive for at least 30 years.
p.(None): quality assurance
p.(None): § 8. (1) Tissue banks are obliged to carry out an audit at least every two years with regard to all activities for which the tissue bank has been approved
p.(None): to have independent, competent and appropriately trained persons carried out. These have to check whether the regulations of the GSG and these
p.(None): Ordinance and the provisions of the operating license are complied with and all activities in accordance with the state of the art in science and technology
p.(None): be carried out. The results of the audit and proposed corrective measures must be documented.
p.(None): (2) Deviations from the required quality or safety standards are to be examined and evaluated and it is based on the evaluation
p.(None): Make a decision about necessary corrective and preventive measures.
p.(None): (3) Corrective measures are to be implemented without unnecessary delay. The implementation must be documented. Preventive and corrective measures are post
p.(None): check their effectiveness for their introduction.
p.(None): Receiving cells and tissues
p.(None): § 9. (1) All inputs of cells or tissues are to be checked upon acceptance to determine whether the delivery including the transport conditions
p.(None): Packaging, labeling including the associated documents and reserve samples of the donors comply with the regulations of
p.(None): Tissue Removal Equipment Ordinance (GEEVO), Federal Law Gazette II № 191/2008, and corresponds to the speci ﬁ cations of the tissue bank. Inputs that meet these requirements
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p.(None): Packaging, labeling including the associated documents and reserve samples of the donors comply with the regulations of
p.(None): Tissue Removal Equipment Ordinance (GEEVO), Federal Law Gazette II № 191/2008, and corresponds to the speci ﬁ cations of the tissue bank. Inputs that meet these requirements
p.(None): do not correspond, must be segregated. They are to be discarded if, based on the deviations, it can be assumed that according to the state of the art and
p.(None): Technology that cells or tissues are not suitable for use in humans.
p.(None): (2) Tissue banks must have written standard operating instructions (SOPs) against which each individual receipt is checked; further about
p.(None): SOPs for handling and segregating inputs that do not meet the requirements or whose test results are incomplete, for each
p.(None): Avoid risk of contamination.
p.(None): (3) This review, including the decision on release for further processing or storage for distribution, must be carried out by one
p.(None): qualified and named person. Until the result of this test is available, the entrances must be stored under quarantine conditions
p.(None): become.
p.(None): (4) tissue banks must
p.(None): 1. Document the following data regarding germ cells intended for partner donation:
p.(None): a) the consent, also with regard to the purpose or purposes for which the tissues or cells may be used as well as other speci ﬁ c
p.(None): Disposal instructions if the tissues or cells are not used for the purpose for which consent has been given
p.(None): b) Donor identity and characteristics: type of donor, age, gender, presence of risk factors,
p.(None): c) partner identity,
p.(None): d) place of extraction and
p.(None): e) Tissues and cells removed and relevant characteristics.
p.(None): 2. With regard to all other inputs, the data in accordance with Section 6 (3)
p.(None): document the GEEVO.
p.(None): (5) Donor samples should be kept for the period based on a risk assessment from the tissue bank
p.(None): was set.
p.(None): processing
p.(None): § 10. (1) Critical processing steps that affect quality and safety are to be specified and validated in manufacturing regulations, they may
p.(None): Do not allow cells or tissues to become clinically ineffective or harmful to the recipient. The validation can be based
p.(None): 1. on studies carried out by the tissue bank itself,
p.(None): 2. on data from publications, or
p.(None): 3. In the case of established processing methods, subsequent evaluation of the clinical results for the cells or tissues distributed by the tissue bank.
p.(None): (2) The processing steps are to be defined in SOPs that correspond to the validated method and are documented in accordance with § 7.
p.(None): (3) It must be ensured that all processing steps in accordance with the approved processing methods, in accordance with the manufacturing regulations and the SOPs
p.(None): be performed. The staff must be trained accordingly.
p.(None): (4) If the cells or tissues are subjected to an inactivation or sterilization process, this must be specified, documented and validated.
p.(None): (5) Significant changes to critical processing steps must be validated and documented before they are introduced.
p.(None): (6) The processing steps are to be evaluated regularly to ensure that they continue to achieve the specified results.
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p.(None): The primary packaging must be attached in such a way that the clear assignment is retained.
p.(None): (2) The following information must be provided either on the primary packaging or in the accompanying documents:
p.(None): 1. Description (definition) and, if applicable, dimensions of the tissue or cell product,
p.(None): 2. if applicable, morphology and functional data,
p.(None): 3. Date of tissue / cell distribution,
p.(None): 4. results of biological tests on the donor,
p.(None): 5. Storage recommendations,
p.(None): 6. Instructions for opening the container, the packaging and any necessary handling / reconstitution,
p.(None): 7. expiry dates after opening / handling,
p.(None): 8. Instructions for reporting serious undesirable reactions or incidents in accordance with the Tissue Vigilance Ordinance, Federal Law Gazette II No. 190/2008,
p.(None): 9. Presence of potentially harmful residues and
p.(None): 10. in the case of imported cells and tissues from third countries, the country in which they were obtained and the exporting country (if different from the country of
p.(None): Recovery).
p.(None): (3) The primary packaging must be transported in an outer packaging, which must contain the following information:
p.(None): 1. the identification of the tissue bank, including address and telephone number,
p.(None): 2. the identifier of the destination responsible for human use, including address and telephone number,
p.(None): 3. the inscription "CAUTION TISSUE AND CELLS",
p.(None): 4. If living cells are required for the transplantation, the inscription: "DO NOT IRRADIATE" must be added
p.(None): 5. Recommended transport conditions (eg "KEEP COOL", "KEEP STORED"), and
p.(None): 6. Safety instructions / cooling procedures, if applicable.
p.(None): Use of the Single European Code
p.(None): § 13a. (1) Tissue banks have after receiving the cells and tissues in accordance with § 12 para. 3 GSG, Federal Law Gazette I No. 49/2008, or when importing
p.(None): Allocate a donation identification sequence to a third country supplier.
p.(None): (2) Tissue banks have to assign a new donation identification number to the final product for pooled cells and tissues and the
p.(None): Ensure traceability to individual donations.
p.(None): (3) The donation identification sequence may no longer be changed if it has been allocated to cells and tissues released for traffic.
p.(None): Coding errors must be corrected and every correction must be fully documented.
p.(None): (4) Tissue banks must have one of the permitted product coding systems and the latest before distribution for use in humans
p.(None): to apply corresponding product numbers for the tissues and cells from the EU Compendium of Cell and Tissue Products.
p.(None): (5) Tissue banks must use a suitable split number and an expiry date.
p.(None): recall
p.(None): § 14. (1) Quali ﬁ ed personnel within the tissue bank must be instructed to assess the need for a recall and the necessary ones
p.(None): Initiate and coordinate measures.
p.(None): (2) There must be an effective recall procedure, including a description of the responsibilities and the measures to be taken.
p.(None): These also include reporting to the Federal Office for Safety in Health Care in accordance with section 17 (3) GSG.
p.(None): (3) Measures such as the tracking and, if necessary, tracing of all relevant tissues and cells are to be carried out within predetermined periods
p.(None): take. These measures identify those donors who may have contributed to causing the recipient's response to available ones
p.(None): Identify tissues and cells from these donors and inform supplied facilities about the potential risk.
p.(None): Reference to European Union legal acts
p.(None): § 15. By this ordinance
p.(None): 1. Directive 2006/86 / EC implementing Directive 2004/23 / EC with regard to traceability requirements, reporting more serious
p.(None): Incidents and undesirable reactions as well as certain technical requirements for coding, processing, preservation, storage and
p.(None): Distribution of human tissues and cells, OJ. L 294, 25.10.2006 p. 32,
p.(None): 2. Directive 2006/17 / EC for the implementation of Directive 2004/23 / EC with regard to technical regulations for the donation, procurement and testing of
p.(None): human tissues and cells, OJ. No.L 35 from 02/09/2006 p. 40 and
p.(None): 3. Directive (EU) 2015/565 amending Directive 2006/86 / EC with regard to certain technical regulations for the coding of human beings
p.(None): Tissues and cells, OJ. No.L 93 from 04/09/2015 p. 43
p.(None): implemented.
p.(None): Come into effect
p.(None): Section 16. Section 7 (6), Section 13 (1) and (2) 8, 9 and 10, Section 13a including the heading, Section 15 including the heading and the annex in the version of the Ordinance BGBl. II
p.(None): No. 18/2017 take effect on April 29, 2017.
p.(None): investment
p.(None): Information from the tissue bank
p.(None): 1. Donor identification
p.(None): 2. Donation ID, which includes at least the following:
p.(None): - Identification of the removal device (with contact details) or tissue bank
p.(None): - Unique donation number
p.(None): - date of procurement
p.(None): - place of procurement
p.(None): - Type of donation (e.g. single vs. multiple tissue donation, autologous vs. allogeneic; living donation vs. postmortem donation)
p.(None): 3. Product identifier, which includes at least the following:
p.(None): - Identification of the tissue bank
p.(None): - Type of tissues and cells / product (basic nomenclature)
p.(None): - Pool number (with pooled material)
p.(None): - split number (if available)
p.(None): - expiry date (if available)
p.(None): - Tissue / cell status (i.e. quarantined, ready to use, etc.)
p.(None): - Description and origin of the products, processing steps, material and additives that come into contact with the tissues and cells and
p.(None): affect their quality and / or safety
p.(None): - Identifier of the organization that will carry out the final identification
p.(None): 4. Single European Code (if available)
p.(None): 5. Human use identifier, which includes at least the following:
p.(None): - Date of distribution / disposal
p.(None): - User ID
p.(None): to the top
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p.(None): Relevant documents in connection with the receipt, processing, testing, storage and distribution of cells and tissues are from the
p.(None): approve the responsible person by signature.
p.(None): staff
p.(None): § 3. (1) Tissue banks must have sufficient qualified personnel to carry out the activities for which they have been authorized.
p.(None): (2) The staff must be trained before starting work and when procedures or new scientific knowledge change
p.(None): receive sufficient opportunities for appropriate professional development. The training programs must ensure that all employees are involved
p.(None): have performed the tasks assigned to them as knowledgeable, have sufficient knowledge and understanding of the
p.(None): scientific / technical procedures and principles that are relevant to the tasks assigned to them, the organizational framework that
p.(None): Understand the quality system as well as the health and safety regulations of the institution in which they work and are sufficiently aware of the other ethical ones
p.(None): and the legal context of their work. Records must be kept of the training measures, in which in particular the date, duration,
p.(None): Place and content as well as all lecturers and participants are listed. The implementation of each training event is by the signature of the
p.(None): To confirm the lecturer and the participants. The specialist knowledge of the staff is to be assessed regularly as part of the quality system.
p.(None): (3) The tasks and areas of responsibility are to be defined in an organizational chart.
p.(None): (4) The tasks and responsibilities of the staff in tissue banks must be set out in job descriptions that are added regularly
p.(None): are updating.
p.(None): (5) The functional descriptions and organizational diagrams must be approved in accordance with internal company procedures.
p.(None): (6) The responsible person is in addition to the tasks according to § 11 and the tasks within the framework of the tissue vigilance regulation, BGBl. II No. 190/2008
p.(None): responsible for ensuring that the tissue bank fulfills its obligations in accordance with paragraphs 1 and 2 within the framework of the documentation, quality assurance, and acceptance,
p.(None): Processing, storage, labeling, packaging and distribution of cells and tissues, as well as in connection with relationships with third parties.
p.(None): (7) The responsible person and all employees in a managerial or responsible position are to be granted sufficient powers to ensure that they have their
p.(None): Can perform tasks.
p.(None): premises
p.(None): § 4. (1) The premises are to be set up and maintained in such a way that they are suitable for the activities for which the tissue bank has been approved. You need to
p.(None): offer the possibility of a logical sequence of the work steps to minimize the risk of errors, as well as effective cleaning and maintenance
p.(None): allow to minimize the risk of contamination.
p.(None): (2) A suitable level of air cleanliness must be maintained for the individual work processes. Cells or tissues are processed at
p.(None): Environmental exposure, this must be done in an environment with speci ﬁ ed air quality and cleanliness to avoid the risk of contamination, including the risk
...

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p.(None): Allocate a donation identification sequence to a third country supplier.
p.(None): (2) Tissue banks have to assign a new donation identification number to the final product for pooled cells and tissues and the
p.(None): Ensure traceability to individual donations.
p.(None): (3) The donation identification sequence may no longer be changed if it has been allocated to cells and tissues released for traffic.
p.(None): Coding errors must be corrected and every correction must be fully documented.
p.(None): (4) Tissue banks must have one of the permitted product coding systems and the latest before distribution for use in humans
p.(None): to apply corresponding product numbers for the tissues and cells from the EU Compendium of Cell and Tissue Products.
p.(None): (5) Tissue banks must use a suitable split number and an expiry date.
p.(None): recall
p.(None): § 14. (1) Quali ﬁ ed personnel within the tissue bank must be instructed to assess the need for a recall and the necessary ones
p.(None): Initiate and coordinate measures.
p.(None): (2) There must be an effective recall procedure, including a description of the responsibilities and the measures to be taken.
p.(None): These also include reporting to the Federal Office for Safety in Health Care in accordance with section 17 (3) GSG.
p.(None): (3) Measures such as the tracking and, if necessary, tracing of all relevant tissues and cells are to be carried out within predetermined periods
p.(None): take. These measures identify those donors who may have contributed to causing the recipient's response to available ones
p.(None): Identify tissues and cells from these donors and inform supplied facilities about the potential risk.
p.(None): Reference to European Union legal acts
p.(None): § 15. By this ordinance
p.(None): 1. Directive 2006/86 / EC implementing Directive 2004/23 / EC with regard to traceability requirements, reporting more serious
p.(None): Incidents and undesirable reactions as well as certain technical requirements for coding, processing, preservation, storage and
p.(None): Distribution of human tissues and cells, OJ. L 294, 25.10.2006 p. 32,
p.(None): 2. Directive 2006/17 / EC for the implementation of Directive 2004/23 / EC with regard to technical regulations for the donation, procurement and testing of
p.(None): human tissues and cells, OJ. No.L 35 from 02/09/2006 p. 40 and
p.(None): 3. Directive (EU) 2015/565 amending Directive 2006/86 / EC with regard to certain technical regulations for the coding of human beings
p.(None): Tissues and cells, OJ. No.L 93 from 04/09/2015 p. 43
p.(None): implemented.
p.(None): Come into effect
p.(None): Section 16. Section 7 (6), Section 13 (1) and (2) 8, 9 and 10, Section 13a including the heading, Section 15 including the heading and the annex in the version of the Ordinance BGBl. II
p.(None): No. 18/2017 take effect on April 29, 2017.
p.(None): investment
p.(None): Information from the tissue bank
p.(None): 1. Donor identification
p.(None): 2. Donation ID, which includes at least the following:
p.(None): - Identification of the removal device (with contact details) or tissue bank
p.(None): - Unique donation number
p.(None): - date of procurement
p.(None): - place of procurement
p.(None): - Type of donation (e.g. single vs. multiple tissue donation, autologous vs. allogeneic; living donation vs. postmortem donation)
p.(None): 3. Product identifier, which includes at least the following:
p.(None): - Identification of the tissue bank
p.(None): - Type of tissues and cells / product (basic nomenclature)
p.(None): - Pool number (with pooled material)
...

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p.(None): biological agents, Federal Law Gazette II No. 237/1998, are not affected by this regulation.
p.(None): (3) The initial provisions of Section 2 of the Tissue Safety Act (GSG), Federal Law Gazette I No. 49/2008, and Section 1 of the Tissue Removal Equipment Ordinance,
p.(None): BGBl. II No. 191/2008, each in the current version, also apply to this regulation.
p.(None): quality system
p.(None): § 2. (1) The quality management of tissue banks includes all coordinated activities related to the management and control of a tissue bank
p.(None): Quality at all levels.
p.(None): (2) Quality is to be striven for by everyone involved in the work processes of the tissue bank, with the management and the responsible
p.(None): Ensure a systematic quality standard and the introduction and maintenance of a quality system according to § 9 GSG
p.(None): (3) The function of the quality management system must be checked regularly to enable continuous and systematic improvements.
p.(None): (4) All written instructions, procedural instructions, speci ﬁ cations, manufacturing instructions, standard operating instructions (SOPs) and others
p.(None): Relevant documents in connection with the receipt, processing, testing, storage and distribution of cells and tissues are from the
p.(None): approve the responsible person by signature.
p.(None): staff
p.(None): § 3. (1) Tissue banks must have sufficient qualified personnel to carry out the activities for which they have been authorized.
p.(None): (2) The staff must be trained before starting work and when procedures or new scientific knowledge change
p.(None): receive sufficient opportunities for appropriate professional development. The training programs must ensure that all employees are involved
p.(None): have performed the tasks assigned to them as knowledgeable, have sufficient knowledge and understanding of the
p.(None): scientific / technical procedures and principles that are relevant to the tasks assigned to them, the organizational framework that
p.(None): Understand the quality system as well as the health and safety regulations of the institution in which they work and are sufficiently aware of the other ethical ones
p.(None): and the legal context of their work. Records must be kept of the training measures, in which in particular the date, duration,
p.(None): Place and content as well as all lecturers and participants are listed. The implementation of each training event is by the signature of the
p.(None): To confirm the lecturer and the participants. The specialist knowledge of the staff is to be assessed regularly as part of the quality system.
p.(None): (3) The tasks and areas of responsibility are to be defined in an organizational chart.
p.(None): (4) The tasks and responsibilities of the staff in tissue banks must be set out in job descriptions that are added regularly
p.(None): are updating.
p.(None): (5) The functional descriptions and organizational diagrams must be approved in accordance with internal company procedures.
p.(None): (6) The responsible person is in addition to the tasks according to § 11 and the tasks within the framework of the tissue vigilance regulation, BGBl. II No. 190/2008
p.(None): responsible for ensuring that the tissue bank fulfills its obligations in accordance with paragraphs 1 and 2 within the framework of the documentation, quality assurance, and acceptance,
p.(None): Processing, storage, labeling, packaging and distribution of cells and tissues, as well as in connection with relationships with third parties.
p.(None): (7) The responsible person and all employees in a managerial or responsible position are to be granted sufficient powers to ensure that they have their
p.(None): Can perform tasks.
p.(None): premises
p.(None): § 4. (1) The premises are to be set up and maintained in such a way that they are suitable for the activities for which the tissue bank has been approved. You need to
p.(None): offer the possibility of a logical sequence of the work steps to minimize the risk of errors, as well as effective cleaning and maintenance
p.(None): allow to minimize the risk of contamination.
p.(None): (2) A suitable level of air cleanliness must be maintained for the individual work processes. Cells or tissues are processed at
p.(None): Environmental exposure, this must be done in an environment with speci ﬁ ed air quality and cleanliness to avoid the risk of contamination, including the risk
p.(None): the cross contamination between individual donations to keep as low as possible. The effectiveness of these measures must be validated and monitored.
p.(None): (3) Unless otherwise provided for in paragraph 4, exposure of cells or tissues to the environment during processing is without
p.(None): subsequent inactivation or sterilization process an air quality with a germ count and particle number according to level A of the definition of the current one
p.(None): Guide to Good Manufacturing Practice, Appendix 1 to Directive 2003/94 / EC establishing the principles and guidelines of Good Manufacturing Practice for
p.(None): Medicinal products for human use and for test preparations intended for use in humans, with one for the processing of the relevant cells or
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General/Other / Natural Hazards

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p.(None): if applicable, the immune status of the recipient.
p.(None): (5) Written hygiene and clothing regulations must be laid down for all work rooms and warehouses.
p.(None): (6) Suitable clothing and equipment for personal protection and hygiene must be provided in all work and storage rooms of the tissue bank.
p.(None): (7) For the storage of cells and tissues, the storage conditions including relevant parameters such as temperature, humidity or
p.(None): Air quality, which are necessary to maintain the required properties of the cells and tissues. Critical parameters are too
p.(None): inspect, monitor and record to demonstrate that the specified storage conditions are met.
p.(None): (8) Storage facilities shall be provided which clearly separate cells and tissues which have not yet been released or
p.(None): distinguish between those that have been released and those that have been rejected to avoid confusion and cross-contamination. Spatially separated areas or
p.(None): Storage devices or the safe separation within the storage device are both in the quarantine and in the release storage area for
p.(None): to maintain certain tissues and cells according to specific criteria.
p.(None): (9) Tissue banks must have written instructions and procedures for access controls, cleaning and maintenance, waste disposal and
p.(None): the behavior in an emergency.
p.(None): equipment
p.(None): Section 5
p.(None): be available in sufficient numbers to ensure processing, storage and distribution that is state of the art. The
p.(None): Equipment must be selected in such a way that a hazard to the cells or tissues, the recipient and / or the personnel is excluded as far as possible or
p.(None): is reduced to the non-excluded minimum.
p.(None): (2) The equipment, which is critical with regard to the product quality, must be identified and qualified according to the intended use,
p.(None): undergo regular inspections and maintain according to the manufacturer's instructions. New and repaired equipment must be closed before commissioning
p.(None): testing. The test results must be documented.
p.(None): (3) If critical processing or storage parameters are affected by the equipment, these are to be determined and must be more appropriate
p.(None): Monitoring, warning, alarm or corrective measures, so that malfunctions and defects are identified and thus it is ensured that the
p.(None): critical parameters are kept within defined limits at all times. Maintenance, repair, cleaning, disinfection and decontamination
p.(None): All critical equipment must be carried out regularly and documented accordingly. There must be procedures for operating each part of the critical
p.(None): Equipment is available that details what action to take in the event of malfunction or failure.
p.(None): (4) Scales, weights and other measuring devices are last changed by the according to the measure and calibration law, Federal Law Gazette № 152/1950
p.(None): Federal Laws BGBl. I № 137/2004 and BGBl. I № 6/2007. According to the result of a risk analysis as critically de ﬁ ned measuring devices that
p.(None): do not fall under the measurement and calibration law, must be appropriately qualified and calibrated.
p.(None): (5) For all activities, the speci ﬁ cations of all critical equipment and reagents as well as speci ﬁ cations for the packaging material must be specified
...

p.(None): Processing steps a documented risk assessment regarding the quality or safety of all already stored tissues and cells and regarding their
p.(None): carry out further use.
p.(None): distribution
p.(None): § 12. (1) Critical transport conditions such as temperature and maximum duration to maintain the required tissue and cell properties are to be specified.
p.(None): (2) The container for the final packaging must be secure and ensure that the quality of the tissues and cells corresponds to the specified
p.(None): Conditions. The safety and practicality of all containers must be validated.
p.(None): (3) If the transport is carried out by third parties, the tissue bank must conclude a written agreement with them to ensure that the
p.(None): necessary conditions are met.
p.(None): (4) Procedures for dealing with requests for tissues and cells must be in place. The rules for the allocation of tissues and cells
p.(None): certain patients or healthcare facilities are to be documented and made available on request.
p.(None): (5) There must be SPOs for handling returned products, including any criteria for their resumption in
p.(None): the stock.
p.(None): Label for distribution
p.(None): § 13. (1) The primary packaging for cells or tissues must contain the following information:
p.(None): 1. type of cells and tissues and, if applicable, lot or batch number,
p.(None): 2. identification of the tissue bank,
p.(None): 3. the Uniform European Code of cells and tissues distributed for use in humans or the donation recognition sequence of the for
p.(None): Traffic-released cells and tissues that are not distributed for use in humans
p.(None): 4. for autologous donation: "ONLY FOR AUTOLOGICAL USE", and details of donor / recipient and
p.(None): 5. the indication "BIOLOGICAL HAZARD" if a product is known to have a positive test result for a marker of a relevant one
p.(None): Infectious disease.
p.(None): If one of the information according to Z 3 and 4 can not be given on the primary packaging, it must be stated on a separate sheet that the
p.(None): The primary packaging must be attached in such a way that the clear assignment is retained.
p.(None): (2) The following information must be provided either on the primary packaging or in the accompanying documents:
p.(None): 1. Description (definition) and, if applicable, dimensions of the tissue or cell product,
p.(None): 2. if applicable, morphology and functional data,
p.(None): 3. Date of tissue / cell distribution,
p.(None): 4. results of biological tests on the donor,
p.(None): 5. Storage recommendations,
p.(None): 6. Instructions for opening the container, the packaging and any necessary handling / reconstitution,
p.(None): 7. expiry dates after opening / handling,
p.(None): 8. Instructions for reporting serious undesirable reactions or incidents in accordance with the Tissue Vigilance Ordinance, Federal Law Gazette II No. 190/2008,
p.(None): 9. Presence of potentially harmful residues and
p.(None): 10. in the case of imported cells and tissues from third countries, the country in which they were obtained and the exporting country (if different from the country of
p.(None): Recovery).
p.(None): (3) The primary packaging must be transported in an outer packaging, which must contain the following information:
p.(None): 1. the identification of the tissue bank, including address and telephone number,
p.(None): 2. the identifier of the destination responsible for human use, including address and telephone number,
p.(None): 3. the inscription "CAUTION TISSUE AND CELLS",
p.(None): 4. If living cells are required for the transplantation, the inscription: "DO NOT IRRADIATE" must be added
...

General/Other / Public Emergency

Searching for indicator emergency:

(return to top)
p.(None): 3. It is not technically possible to carry out the required process in a level A environment.
p.(None): The environmental conditions must be specified. It must be demonstrated and documented that the required quality and the required environment
p.(None): Safety of the cells or tissues can be achieved, this taking into account the intended purpose, the type of use and
p.(None): if applicable, the immune status of the recipient.
p.(None): (5) Written hygiene and clothing regulations must be laid down for all work rooms and warehouses.
p.(None): (6) Suitable clothing and equipment for personal protection and hygiene must be provided in all work and storage rooms of the tissue bank.
p.(None): (7) For the storage of cells and tissues, the storage conditions including relevant parameters such as temperature, humidity or
p.(None): Air quality, which are necessary to maintain the required properties of the cells and tissues. Critical parameters are too
p.(None): inspect, monitor and record to demonstrate that the specified storage conditions are met.
p.(None): (8) Storage facilities shall be provided which clearly separate cells and tissues which have not yet been released or
p.(None): distinguish between those that have been released and those that have been rejected to avoid confusion and cross-contamination. Spatially separated areas or
p.(None): Storage devices or the safe separation within the storage device are both in the quarantine and in the release storage area for
p.(None): to maintain certain tissues and cells according to specific criteria.
p.(None): (9) Tissue banks must have written instructions and procedures for access controls, cleaning and maintenance, waste disposal and
p.(None): the behavior in an emergency.
p.(None): equipment
p.(None): Section 5
p.(None): be available in sufficient numbers to ensure processing, storage and distribution that is state of the art. The
p.(None): Equipment must be selected in such a way that a hazard to the cells or tissues, the recipient and / or the personnel is excluded as far as possible or
p.(None): is reduced to the non-excluded minimum.
p.(None): (2) The equipment, which is critical with regard to the product quality, must be identified and qualified according to the intended use,
p.(None): undergo regular inspections and maintain according to the manufacturer's instructions. New and repaired equipment must be closed before commissioning
p.(None): testing. The test results must be documented.
p.(None): (3) If critical processing or storage parameters are affected by the equipment, these are to be determined and must be more appropriate
p.(None): Monitoring, warning, alarm or corrective measures, so that malfunctions and defects are identified and thus it is ensured that the
p.(None): critical parameters are kept within defined limits at all times. Maintenance, repair, cleaning, disinfection and decontamination
p.(None): All critical equipment must be carried out regularly and documented accordingly. There must be procedures for operating each part of the critical
p.(None): Equipment is available that details what action to take in the event of malfunction or failure.
p.(None): (4) Scales, weights and other measuring devices are last changed by the according to the measure and calibration law, Federal Law Gazette № 152/1950
p.(None): Federal Laws BGBl. I № 137/2004 and BGBl. I № 6/2007. According to the result of a risk analysis as critically de ﬁ ned measuring devices that
...

Orphaned Trigger Words

Appendix

Indicator List

Indicator	Vulnerability
access	Access to Social Goods
age	Age
emergency	Public Emergency
employees	employees
family	Motherhood/Family
gender	gender
hazard	Natural Hazards
home	Property Ownership
job	Occupation
single	Marital Status
union	Trade Union Membership
youth	Youth/Minors

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers

Trigger Words

consent

protection

risk

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Health	Motherhood/Family	family	1
Social	Access to Social Goods	access	2
Social	Age	age	1
Social	Marital Status	single	3
Social	Occupation	job	1
Social	Property Ownership	home	1
Social	Trade Union Membership	union	1
Social	Youth/Minors	youth	1
Social	employees	employees	2
Social	gender	gender	1
General/Other	Natural Hazards	hazard	2
General/Other	Public Emergency	emergency	1

Regulation on Tissue Banks (2014)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Health / Motherhood/Family

Social / Access to Social Goods

Social / Age

Social / Marital Status

Social / Occupation

Social / Property Ownership

Social / Trade Union Membership

Social / Youth/Minors

Social / employees

Social / gender

General/Other / Natural Hazards

General/Other / Public Emergency

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input