GB/T 16886.2-2026Biological 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
Also coversGB/T16886.2-2026 + GBT16886.2-2026
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
January 28, 2026
Implementation date
February 1, 2027
Scope
GB/T 16886.2-2026 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.
Biological safety testing of medical devices sometimes involves animals, and this standard, Part 2 of the biological evaluation series, deals with animal welfare requirements. It addresses the ethical conduct of such work and sits alongside the other parts of the series that cover the evaluation process and individual tests. It is a recommended national standard.
Medical device manufacturers, contract research and testing organisations, animal facility managers, regulatory affairs specialists and ethics committees are the principal readers. Companies preparing biocompatibility evidence for registration in China will need to know how animal use is expected to be managed.
The standard was issued on 28 January 2026 and takes effect on 1 February 2027. It replaces GB/T 16886.2-2011. Test facilities and sponsors that have built their procedures on the earlier edition should plan to review them before the new one applies.
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Document preview — GB/T 16886.2-2026
National Standard of the People's Republic of China
- ICS
- 11.100.20
- Classification
- C30
- Replacing
- GB/T 16886.2-2011
Issued by: State Administration for Market Regulation; Standardization Administration of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
Foreword
GB/T 16886.2-2026 is a recommended national standard (GB/T) of the People's Republic of China, issued on 28 January 2026 by the State Administration for Market Regulation and the Standardization Administration of China, with effect from 1 February 2027.
This edition replaces GB/T 16886.2-2011.
The document adopts an international standard (ISO or IEC).
It is under the responsibility of the National Medical Products Administration.
Classification: ICS 11.100.20; CCS C30.
1 Scope
Biological safety testing of medical devices sometimes involves animals, and this standard, Part 2 of the biological evaluation series, deals with animal welfare requirements. It addresses the ethical conduct of such work and sits alongside the other parts of the series that cover the evaluation process and individual tests. It is a recommended national standard.
Medical device manufacturers, contract research and testing organisations, animal facility managers, regulatory affairs specialists and ethics committees are the principal readers. Companies preparing biocompatibility evidence for registration in China will need to know how animal use is expected to be managed.
The standard was issued on 28 January 2026 and takes effect on 1 February 2027. It replaces GB/T 16886.2-2011. Test facilities and sponsors that have built their procedures on the earlier edition should plan to review them before the new one applies.
Remaining clauses in the full document
- 2 Normative references
- 3 Terms and definitions
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.
Referenced standards
Cited by
- YY/T 0942-2026Ophthalmic optics. Injection system of intraocular lenses
- YY/T 1431-2026Implants for surgery. Medical-grade ultra-high molecular weight polyethylene yarns
- GB/T 12279.3-2025Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
- GB/T 12279.2-2024Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
- 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
Similar standards
Editions of GB/T 16886.2
| Edition | Title | Revision | Status |
|---|---|---|---|
| GB/T 16886.2-2026 | Biological evaluation of medical devices - Part 2: Animal welfare requirements | current edition | Current |
| GB/T 16886.2-2011 | Biological evaluation of medical devices - Part 2: Animal welfare requirements | previous edition | In force until 1 February 2027 |
This page sells the current edition, GB/T 16886.2-2026. Earlier editions are listed for reference only.
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Related Standards
GB/T 16886.3-2019 — Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.4-2022 — Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
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