GB/T 16886.16-2013Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (English PDF)
医疗器械生物学评价 第16部分：降解产物与可沥滤物毒代动力学研究设计
GB/T 16886.16 | Evolution and historical versions
| Std ID | Title | Status |
|---|---|---|
| GB/T 16886.16-2021 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables | Valid |
| GB/T 16886.16-2013 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables | Obsolete |
GB/T 16886.16-2013 is obsolete. It has been replaced by GB/T 16886.16-2021. 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 17, 2013
Implementation date
August 1, 2014
Scope
GB/T 16886.16-2013 is the English-translated version of 医疗器械生物学评价 第16部分：降解产物与可沥滤物毒代动力学研究设计.
GB/T 16886.16-2013 is the Chinese national standard "Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables".
It was issued on December 17, 2013 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 August 1, 2014. It is obsolete: it has been replaced by GB/T 16886.16-2021.
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Document preview — GB/T 16886.16-2013
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: 2013-12-17.
Date of implementation: 2014-08-01.
Status: obsolete, replaced by GB/T 16886.16-2021.
......
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 0942-2026Ophthalmic optics. Injection system of intraocular lenses
- YY 0861-2024Ophthalmic optics - Ophthalmic viscosurgical devices
- YY/T 0727.2-2009Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components
- YY/T 0606.5-2007Tissue Engineered Medical Products - Part 5: Characterization and Testing of Substrates and Scaffolds
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Related Standards
GB/T 16886.17-2025 — Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
GB/T 16886.15-2003 — Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
GB/T 16886.17-2005 — Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
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GB/T 16886.16-2013
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