GB/T 16886.17-2025Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (English PDF)
医疗器械生物学评价 第17部分：医疗器械成分的毒理学风险评估
Also coversGB/T16886.17-2025 + GBT16886.17-2025
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
August 29, 2025
Implementation date
September 1, 2026
Scope
GB/T 16886.17-2025 is the English-translated version of 医疗器械生物学评价 第17部分：医疗器械成分的毒理学风险评估.
Part 17 of the biological evaluation series describes how the toxicological risk of the constituents of a medical device is assessed. According to its scope, it specifies the process and requirements for this assessment, together with the methods and criteria used to decide whether exposure to a constituent is without appreciable harm.
The assessment can form part of the biological evaluation of the finished product and applies to chemical characterization information, such as compositional data or extractables and leachables results. The scope also lists circumstances where the process is not intended to apply, for example where exposure falls below a toxicologically based reporting threshold or where equivalence to an established device has already been shown.
Manufacturers, toxicologists, biocompatibility consultants, test laboratories and regulatory affairs teams will use it when preparing evidence for registration. The standard was issued on 29 August 2025 and takes effect on 1 September 2026, replacing GB/T 16886.17-2005. It is a recommended national standard.
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Document preview — GB/T 16886.17-2025
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C30
- Replacing
- GB/T 16886.17-2005
Issued by: State Administration for Market Regulation; Standardization Administration of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
Foreword
GB/T 16886.17-2025 is a recommended national standard (GB/T) of the People's Republic of China, issued on 29 August 2025 by the State Administration for Market Regulation and the Standardization Administration of China, with effect from 1 September 2026.
This edition replaces GB/T 16886.17-2005.
The document adopts an international standard (ISO or IEC).
It is under the responsibility of the National Medical Products Administration.
Classification: ICS 11.100; CCS C30.
1 Scope
Part 17 of the biological evaluation series describes how the toxicological risk of the constituents of a medical device is assessed. According to its scope, it specifies the process and requirements for this assessment, together with the methods and criteria used to decide whether exposure to a constituent is without appreciable harm.
The assessment can form part of the biological evaluation of the finished product and applies to chemical characterization information, such as compositional data or extractables and leachables results. The scope also lists circumstances where the process is not intended to apply, for example where exposure falls below a toxicologically based reporting threshold or where equivalence to an established device has already been shown.
Manufacturers, toxicologists, biocompatibility consultants, test laboratories and regulatory affairs teams will use it when preparing evidence for registration. The standard was issued on 29 August 2025 and takes effect on 1 September 2026, replacing GB/T 16886.17-2005. It is a recommended national standard.
Remaining clauses in the full document
- 2 Normative references
- 3 Terms and definitions
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 41 pages — is available in the English PDF.
Referenced standards
Cited by
- GB/T 47144-2026Requirements for the development, validation and routine control of cleaning processes for medical devices
- YY/T 0942-2026Ophthalmic optics. Injection system of intraocular lenses
- YY/T 1431-2026Implants for surgery. Medical-grade ultra-high molecular weight polyethylene yarns
- YY/T 1815-2022Biological evaluation of medical devices-Application for the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
- YY/T 1823-2022Cardiovascular implants-Standard test method for nickel ion release of nickel-titanium alloy
- YY/T 1778.1-2021Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
Similar standards
Editions of GB/T 16886.17
| Edition | Title | Revision | Status |
|---|---|---|---|
| GB/T 16886.17-2025 | Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents | current edition | Current |
| GB/T 16886.17-2005 | Biological evaluation of medical devices - Part 17: Estabilishment of allowable limits for leachable substances | previous edition | In force until 1 September 2026 |
This page sells the current edition, GB/T 16886.17-2025. Earlier editions are listed for reference only.
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Related Standards
GB/T 16886.18-2022 — Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
GB/T 16886.16-2021 — Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
GB/T 16886.19-2022 — Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
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GB/T 16886.17-2025
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