GB/T 16886.9-2017Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (English PDF)
医疗器械生物学评价 第9部分：潜在降解产物的定性和定量框架
GB/T 16886.9 | Evolution and historical versions
| Std ID | Title | Status |
|---|---|---|
| GB/T 16886.9-2022 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products | Valid |
| GB/T 16886.9-2017 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products | Obsolete |
GB/T 16886.9-2017 is obsolete. It has been replaced by GB/T 16886.9-2022. This page sells the obsolete edition, for projects and contracts that still cite it.
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Issued by
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China; Standardization Administration of China
Level / Type
National · Recommended
Issue date
December 29, 2017
Implementation date
July 1, 2018
Scope
GB/T 16886.9-2017 is the English-translated version of 医疗器械生物学评价 第9部分：潜在降解产物的定性和定量框架.
GB/T 16886.9-2017 is the Chinese national standard "Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products".
It was issued on December 29, 2017 by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China and the Standardization Administration of China, and took effect on July 1, 2018. It is obsolete: it has been replaced by GB/T 16886.9-2022.
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Document preview — GB/T 16886.9-2017
National Standard of the People's Republic of China
Issued by: General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China; Standardization Administration of China
Contents
- Document data
1 Document data
Sector: National standard (Recommended).
Issuing body: General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China; Standardization Administration of China.
Date of issue: 2017-12-29.
Date of implementation: 2018-07-01.
Status: obsolete, replaced by GB/T 16886.9-2022.
......
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
Cited by
- YY/T 1431-2026Implants for surgery. Medical-grade ultra-high molecular weight polyethylene yarns
- GB/T 44353.1-2024Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
- YY 0861-2024Ophthalmic optics - Ophthalmic viscosurgical devices
- YY/T 0811-2021Extensively irradiation-crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications
- YY/T 1512-2017Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process
- YY/T 0984-2016Lacrimal plug
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Related Standards
GB/T 16886.10-2024 — Biological evaluation of medical devices - Part 10: Tests for skin sensitization
GB/T 16886.7-2001 — Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
GB/T 16886.10-2017 — Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
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GB/T 16886.9-2017
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