GB/T 16886.10-2017Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (English PDF)
医疗器械生物学评价 第10部分：刺激与皮肤致敏试验
GB/T 16886.10 | Evolution and historical versions
| Std ID | Title | Status |
|---|---|---|
| GB/T 16886.10-2024 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization | Valid |
| GB/T 16886.10-2017 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Obsolete |
GB/T 16886.10-2017 is obsolete. It has been replaced by GB/T 16886.10-2024. 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 16886.10-2017 is the English-translated version of 医疗器械生物学评价 第10部分：刺激与皮肤致敏试验.
GB/T 16886.10-2017 is the Chinese national standard "Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization".
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 It is obsolete: it has been replaced by GB/T 16886.10-2024.
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Document preview — GB/T 16886.10-2017
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Status: obsolete, replaced by GB/T 16886.10-2024.
......
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
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- GB/T 45481-2025Silicone rubber compounds for medical catheters
- YY/T 1567-2025Female condoms - Requirements and test methods
- YY/T 1985-2025Tissue engineered medical devices - Collagen
- GB/T 44666-2024Finger orthoses
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Related Standards
GB/T 16886.11-2021 — Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
GB/T 16886.9-2001 — Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
GB/T 16886.11-2011 — Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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GB/T 16886.10-2017
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