GB/T 16886.1-2022Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (English PDF)
医疗器械生物学评价 第1部分：风险管理过程中的评价与试验
Also coversGB/T 16886.1-2022/ISO 10993-1:2018 + ISO 10993-1:2018
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
April 15, 2022
Implementation date
May 1, 2023
Scope
GB/T 16886.1-2022 is the English-translated version of 医疗器械生物学评价 第1部分：风险管理过程中的评价与试验.
GB/T 16886.1-2022 is the Chinese standard "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Its scope clause reads: This document specifies. - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of medical devices based on the nature and duration of their contact with the body; - the evaluation of existing relevant data from all sources.
Other parts of GB/T 16886 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing. Its clauses include terms and definitions; categorization of medical devices; biological evaluation process.
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Document preview — GB/T 16886.1-2022
National Standard of the People's Republic of China
- ICS
- 11.100.20
- Classification
- C 30
- Replacing
- GB/T 16886.1-2011
Issued by: State Administration for Market Regulation; Standardization Administration of China
Contents
- Foreword3
- Introduction6
- 1 Scope10
- 2 Normative references11
- 3 Terms and definitions13
- 4 General principles applying to biological evaluation of medical devices18
- 5 Categorization of medical devices23
- 5.1 General23
- 5.2 Categorization by nature of body contact24
- 5.2.1 Non-contacting medical devices24
- 5.2.2 Surface-contacting medical devices24
- 5.2.3 Externally communicating medical devices25
- 5.2.4 Implant medical devices25
- 5.3 Categorization by duration of contact26
- 5.3.1 Contact duration categories26
- 5.3.2 Transitory-contacting medical devices26
- 5.3.3 Medical devices with multiple contact duration categories26
- 6 Biological evaluation process27
- 6.1 Physical and chemical information for biological risk analysis27
- 6.2 Gap analysis and selection of biological endpoints for assessment28
- 6.3 Biological testing29
- 6.3.1 General29
- 6.3.2 Testing for evaluation30
- Annex A (Informative) Endpoints to be addressed in a biological risk assessment38
- management process44
- Annex C (Informative) Suggested procedure for literature review62
- Bibliography65
1 Scope
This document specifies.
- the general principles governing the biological evaluation of medical devices within a risk management process;
- the general categorization of medical devices based on the nature and duration of their contact with the body;
- the evaluation of existing relevant data from all sources.
Other parts of GB/T 16886 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing.
2 Normative references
The contents of the following documents, through normative references in this text, constitute indispensable provisions of this document. Among them, for dated references, only the edition corresponding to that date applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16886.2-2011 Biological evaluation of medical devices - Part 2.Animal welfare requirements (ISO 10993-2.2006, IDT)
GB/T 16886.11-2021 Biological evaluation of medical devices - Part 11.Tests for systemic toxicity (ISO 10993-11.2017, IDT)
YY/T 0316-2016 Medical devices - Application of risk management to medical devices (ISO 14971.2007, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses.
3.1 Biocompatibility
Ability of a medical device (3.14) or material (3.12) to perform with an appropriate host response in a specific application.
3.2 Biological risk
Combination of the probability of harm to health occurring as a result of adverse reactions associated with medical device (3.14) or material (3.12) interactions with human body, and the severity of that harm.
3.3 Biological safety
Freedom from unacceptable biological risk (3.2) in the context of the intended use.
4 General principles applying to biological evaluation of medical devices 4.1 The evaluation of any material or medical device intended for use in humans shall form part of a structured biological evaluation plan within a risk management process in accordance with YY/T 0316-2016.
5 Categorization of medical devices
5.1 General
Medical devices shall be categorized according to the nature and duration of body contact as specified in 5.2 and 5.3.The categorization of medical devices facilitates identification of appropriate data sets (see Annex A).
The evaluation of any medical device that does not fall into one of the categories specified shall follow the general principles contained in this document. Certain medical devices might fall into more than one category, in which case evaluation appropriate to each category shall be carried out.
6 Biological evaluation process
6.1 Physical and chemical information for biological risk analysis
Figure 1 indicates how the general steps in the physical and/or chemical characterization process link to the overall biological evaluation decision points.
Gathering physical and chemical information on the medical device or component is a crucial first step in the biological evaluation and its associated process of material characterization. These data should be sufficient to answer the first two rows of questions in the Figure 1 flow chart.
7 Interpretation of biological evaluation data and overall biological risk assessment
Expert assessors who have the necessary knowledge and experience shall determine and document.
a) the strategy and planned content for the biological evaluation of the medical device;
b) the criteria for determining the acceptability of the material for the intended purpose, in line with the risk management plan;
c) the adequacy of the material characterization.
GB/T 16886.10-2024 | GB/T 16886.12-2023 | GB/T 16886.11-2021 | GB/T 16886.2-2026 | […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 38 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 16886.2-2011Biological evaluation of medical devices -- Part 2: Animal welfare requirements
- GB/T 16886.11-2021Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- YY/T 0316-2016Medical devices-Application of risk management to medical devices
ISO 10993-2 · ISO 10993-3 · ISO 10993-4 · ISO 10993-5 · ISO 10993-6 · ISO 10993-7 · ISO 10993-9 · ISO 10993-10 · ISO 10993-11 · ISO 10993-12 · ISO 10993-13 · ISO 10993-14 · ISO 10993-15 · ISO 10993-16 · ISO 10993-17 · ISO 10993-18 · ISO/TS 10993-20 · ISO 14971
Cited by
- YY/T 1293.3-2026Contacting wound dressing - Part 3: Carboxy methylcellulose sodium dressing
- YY/T 1438-2026Anesthesia and respiratory equipment - Peak expiratory flow rate for evaluating spontaneously breathing lung function
- YY/T 2004.1-2026Traditional Chinese Medicine Instruments - Dermal Needling - Part 1: Tapping Technique
- YY/T 2005-2026Traditional Chinese medical device - Acupotomy
- YY/T 2008-2026Medical additive manufacturing - Powders of polyether-ether-ketone for powder bed fusion
- GB 11417.2-2025Ophthalmic optics - Contact lenses - Part 2: Rigid contact lenses
Similar standards
Editions of GB/T 16886.1
| Edition | Title | Revision | Status |
|---|---|---|---|
| GB/T 16886.1-2022 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, IDT) | — | Current |
| GB/T 16886.1-2011 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | — | Superseded |
| GB/T 16886.1-2001 | Biological evaluation of medical devices - Part 1: Evaluation and testing | — | Superseded |
| GB/T 16886.1-1997 | Biological evaluation of medical devices - Part 1: Evaluation and testing | — | Superseded |
This page sells the current edition, GB/T 16886.1-2022. Earlier editions are listed for reference only.
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Related Standards
GB/T 16886.11-2021 — Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
GB/T 16886.2-2011 — Biological evaluation of medical devices -- Part 2: Animal welfare requirements
YY/T 0316-2016 — Medical devices-Application of risk management to medical devices
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