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GB/T 16886.1-2022 English PDF (GBT16886.1-2022)

GB/T 16886.1-2022 English PDF (GBT16886.1-2022)

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GB/T 16886.1-2022: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

GB/T 16886.1-2022
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.100.20
CCS C 30
GB/T 16886.1-2022 / ISO 10993-1:2018
Replacing GB/T 16886.1-2011
Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process
(ISO 10993-1:2018, IDT)
ISSUED ON: APRIL 15, 2022
IMPLEMENTED ON: MAY 01, 2023
Issued by: State Administration for Market Regulation;
Standardization Administration of the PRC.
Table of Contents
Foreword ... 3
Introduction ... 6
1 Scope ... 10
2 Normative references ... 11
3 Terms and definitions ... 13
4 General principles applying to biological evaluation of medical devices ... 18 5 Categorization of medical devices ... 23
5.1 General ... 23
5.2 Categorization by nature of body contact ... 24
5.2.1 Non-contacting medical devices ... 24
5.2.2 Surface-contacting medical devices ... 24
5.2.3 Externally communicating medical devices ... 25
5.2.4 Implant medical devices ... 25
5.3 Categorization by duration of contact ... 26
5.3.1 Contact duration categories ... 26
5.3.2 Transitory-contacting medical devices ... 26
5.3.3 Medical devices with multiple contact duration categories ... 26 6 Biological evaluation process ... 27
6.1 Physical and chemical information for biological risk analysis ... 27 6.2 Gap analysis and selection of biological endpoints for assessment ... 28 6.3 Biological testing ... 29
6.3.1 General ... 29
6.3.2 Testing for evaluation ... 30
7 Interpretation of biological evaluation data and overall biological risk assessment 36 Annex A (Informative) Endpoints to be addressed in a biological risk assessment ... 38 Annex B (Informative) Guidance on the conduct of biological evaluation within a risk management process ... 44
Annex C (Informative) Suggested procedure for literature review ... 62 Bibliography ... 65
Foreword
This document is drafted in accordance with GB/T 1.1-2020 "Directives for standardization - Part 1: Rules for the structure and drafting of standardizing documents".
The document is Part 1 of GB/T 16886 "Biological evaluation of medical devices". GB/T 16886 has issued the following parts:
- Part 1: Evaluation and testing within a risk management process;
- Part 2: Animal welfare requirements;
- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity; - Part 4: Selection of tests for interactions with blood;
- Part 5: Tests for in vitro cytotoxicity;
- Part 6: Tests for local effects after implantation;
- Part 7: Ethylene oxide sterilization residuals;
- Part 9: Framework for identification and quantification of potential degradation products;
- Part 10: Tests for irritation and skin sensitization;
- Part 11: Tests for systemic toxicity;
- Part 12: Sample preparation and reference materials;
- Part 13: Identification and quantification of degradation products from polymeric medical devices;
- Part 14: Identification and quantification of degradation products from ceramics; - Part 15: Identification and quantification of degradation products from metals and alloys;
- Part 16: Toxicokinetic study design for degradation products and leachables; - Part 17: Establishment of allowable limits for leachable substances;
- Part 18: Chemical characterization of materials;
- Part 19: Physico-chemical, morphological and topographical characterization of materials;
- Part 20: Principles and methods for immunotoxicology testing of medical devices. This document replaces GB/T 16886.1-2011 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Compared with GB/T 16886.1-2011, in addition to structural adjustment and editorial changes, the main technical changes are as follows:
a) Add the scope of applicability and inapplicability for carrying out biological hazard assessment (see Clause 1);
b) Add some terms and definitions used in GB/T 16886 (see Clause 3);
c) Add nanomaterial (see 3.15, 4.3, 6.1, 6.3.2, 6.3.2.13, 6.3.2.14, 6.3.2.15, B.3.1.2, B.4.1.4) and absorbable material evaluation information (see B.4.3.3 and B.4.4.2); d) Add biological evaluation procedures for medical devices [see 4.1 a)]; e) Add the content of the overall biological evaluation of medical devices [see 4.3 c)];
f) Add biological safety assessment requirements for "whole life-cycle of a medical device" and "re-usable medical devices" (see 4.7 and 4.8);
g) Change the "Summary of the systematic approach to a biological evaluation of medical devices as part of a risk management process" (see Figure 1; Figure 1 of the 2011 edition);
h) Add requirements for biological risk assessment of commercially-marketed medical devices when the edition of this document is updated (see 4.11); i) Add the evaluation information of "Non-contacting medical devices" (see 5.2.1) and the evaluation information of "Transitory-contacting medical devices" (see 5.3.2);
j) Change the description of medical devices that contact tissue, bone or pulp/dentin systems [see 5.2.3 b); 5.2.2 b) of the 2011 edition];
k) Add "Gap analysis and selection of biological endpoints for assessment" (see 6.2); l) Add procedures to be considered in selecting biological testing [see 5) in item b) of 6.3.1];
m) Add requirements for acute systemic toxicity test or risk assessment (see 6.3.2.6); n) Add the principle of using animal tests for biological endpoint studies (see 6.3.2.9); o) Change the situation of considering biodegradation tests (see 6.3.2.13; 6.2.2.13 of the 2011 edition);
Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process
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;
- the identification of gaps in the available data set on the basis of a risk analysis; - the identification of additional data sets necessary to analyse the biological safety of the medical device;
- the assessment of the biological safety of the medical device.
This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with:
- the patient's body during intended use;
- the user’s body, if the medical device is intended for protection (e.g., surgical gloves, masks and others).
This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices. This document also gives guidelines for the assessment of biological hazards arising from:
- risks, such as changes to the medical device over time, as a part of the overall biological safety assessment;
- breakage of a medical device or medical device component which exposes body tissue to new or novel materials.
Other parts of GB/T 16886 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing. This document excludes hazards related to bacteria, fungi, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.
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)
ISO 10993-2 Biological evaluation of medical devices - Part 2: Animal welfare requirements
ISO 10993-3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Note: GB/T 16886.3-2019 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014, IDT) ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
Note: GB/T 16886.4-2022 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017, IDT)
ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Note: GB/T 16886.5-2017 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009, IDT)
ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
Note: GB/T 16886.6-2022 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016, IDT)
ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide

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