GB/T 16886.3-1997Biological evaluation of medical devices--Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (English PDF)
医疗器械生物学评价 第3部分:遗传毒性、致癌性和生殖毒性试验
GB/T 16886.3 | Evolution and historical versions
| Std ID | Title | Status |
|---|---|---|
| GB/T 16886.3-2019 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | Valid |
| GB/T 16886.3-2008 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | Obsolete |
| GB/T 16886.3-1997 | Biological evaluation of medical devices--Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | Obsolete |
GB/T 16886.3-1997 is obsolete. It has been replaced by GB/T 16886.3-2008. This page sells the obsolete edition, for projects and contracts that still cite it.
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Issued by
State Bureau of Technical Supervision
Level / Type
National · Recommended
Issue date
June 26, 1997
Implementation date
December 1, 1997
Scope
GB/T 16886.3-1997 is the English-translated version of 医疗器械生物学评价 第3部分:遗传毒性、致癌性和生殖毒性试验.
GB/T 16886.3-1997 is the Chinese national standard "Biological evaluation of medical devices--Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity".
It was issued on June 26, 1997 by the State Bureau of Technical Supervision, and took effect on December 1, 1997. It is obsolete: it has been replaced by GB/T 16886.3-2008.
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Document preview — GB/T 16886.3-1997
National Standard of the People's Republic of China
Issued by: State Bureau of Technical Supervision
Contents
- Document data
1 Document data
Sector: National standard (Recommended).
Issuing body: State Bureau of Technical Supervision.
Date of issue: 1997-06-26.
Date of implementation: 1997-12-01.
Status: obsolete, replaced by GB/T 16886.3-2008.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — all pages — is available in the English PDF.
Referenced standards
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- YY/T 1431-2026Implants for surgery. Medical-grade ultra-high molecular weight polyethylene yarns
- GB/T 14233.2-2025Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
- YY/T 1567-2025Female condoms - Requirements and test methods
- GB/T 44875-2024Fallopian rings - Requirements and test methods
- YY/T 0870.8-2024Test for genotoxicity of medical devices - Part 8: In vivo mammalian liver cell unscheduled DNA synthesis test
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Related Standards
GB/T 16886.4-2022 — Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
GB/T 16886.2-2000 — Biological evaluation of medical devices--Part 2: Animal welfare requirements
GB/T 16886.4-2003 — Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
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GB/T 16886.3-1997
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