GB/T 16886.2-2011Biological evaluation of medical devices -- Part 2: Animal welfare requirements (English PDF)
医疗器械生物学评价 第 2 部分：动物福利要求
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Issued by
General Administration of Quality Supervision, Inspection and Quarantine
Level / Type
National · Recommended
Issue date
December 30, 2011
Implementation date
May 1, 2012
Scope
GB/T 16886.2-2011 is the English-translated version of 医疗器械生物学评价 第 2 部分：动物福利要求.
GB/T 16886.2-2011 is the Chinese standard "Biological evaluation of medical devices -- Part 2: Animal welfare requirements".
Its scope clause reads: This part of GB/T 16886 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves.
It specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices, and form the relevant documents.
It also makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.
It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.
It does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized. Its clauses include terms and definitions.
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Document preview — GB/T 16886.2-2011
National Standard of the People's Republic of China
- ICS
- 11.040.01
- Classification
- C 30
Issued by: General Administration of Quality Supervision, Inspection and Quarantine
Contents
- Foreword3
- Introduction5
- 1 Scope6
- 2 Normative References6
- 3 Terms and Definitions6
- 4 Requirements8
- Annex A (Informative) Rationale for the Development of this Part16
- Refining Animal Tests21
- Bibliography23
1 Scope
This part of GB/T 16886 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves. It specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices, and form the relevant documents.
It also makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.
It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.
It does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and
Testing within a Risk Management Process
3 Terms and Definitions
For the purposes of this document, the definitions given in ISO 10993-1 and the
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
ISO 10993
Cited by
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- GB/T 16886.10-2024Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- GB/T 44353.1-2024Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
- YY/T 0870.8-2024Test for genotoxicity of medical devices - Part 8: In vivo mammalian liver cell unscheduled DNA synthesis test
- YY/T 1754.4-2024Preclinical animal study of medical devices - Part 4: Acute trauma model for evaluating the healing promoting performance of dressings
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Related Standards
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.10-2024 — Biological evaluation of medical devices - Part 10: Tests for skin sensitization
GB/T 16886.11-2021 — Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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