GB/T 16886.11-2011Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (English PDF)
医疗器械生物学评价 第11部分：全身毒性试验
GB/T 16886.11 | Evolution and historical versions
| Std ID | Title | Status |
|---|---|---|
| GB/T 16886.11-2021 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Valid |
| GB/T 16886.11-2011 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Obsolete |
GB/T 16886.11-2011 is obsolete. It has been replaced by GB/T 16886.11-2021. 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 30, 2011
Implementation date
May 1, 2012
Scope
GB/T 16886.11-2011 is the English-translated version of 医疗器械生物学评价 第11部分：全身毒性试验.
GB/T 16886.11-2011 is the Chinese national standard "Biological evaluation of medical devices - Part 11: Tests for systemic toxicity".
It was issued on December 30, 2011 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 May 1, 2012. It is obsolete: it has been replaced by GB/T 16886.11-2021.
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Document preview — GB/T 16886.11-2011
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: 2011-12-30.
Date of implementation: 2012-05-01.
Status: obsolete, replaced by GB/T 16886.11-2021.
......
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
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- YY 0580-2024Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial line blood filters
- YY 0603-2024Cardiopulmonary bypass systems - Hard-shell cardiotomy/venous reservoirs (with or without filter) and soft venous reservoir bags
- YY/T 0127.19-2023Biological evaluation of medical devices used in dentistry - Part 19: Subacute and subchronic systemic toxicity test: implantation route
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Related Standards
GB/T 16886.12-2023 — Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
GB/T 16886.10-2000 — Biological evaluation of medical devices--Part 10: Tests for irritation and sensitization
GB/T 16886.12-2017 — Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
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GB/T 16886.11-2011
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