GB/T 16886.1-2022 PDF English
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Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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GB/T 16886.1-2022: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT16886.1-2022
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);
p) Change the situation of considering toxicokinetic studies (see 6.3.2.14; 6.2.2.14
of the 2011 edition).
This document is identical to ISO 10993-1.2018 "Biological evaluation of medical
devices - Part 1.Evaluation and testing within a risk management process".
The following minimal editorial change has been made to this document.
- Add hint for PBPK model in 6.3.2.14 in vivo toxicokinetic studies.
Attention is drawn to the possibility that some of the elements of this document may be
the subject of patent rights. The issuing authority of this document shall not be held
responsible for identifying any or all such patent rights.
This document was proposed by National Medical Products Administration.
This document shall be under the jurisdiction of National Technical Committee 248 on
Biological Evaluation of Medical Devices of Standardization Administration of China
(SAC/TC 248).
Drafting organizations of this document. Shandong Institute of Medical Device and
Pharmaceutical Packaging Inspection; Center for Medical Device Evaluation. NMPA.
Main drafters of this document. Shi Yanping, Liu Chenghu, Shi Xinli, Zhao Peng, Sun
Xiaoxia, Liu Wenbo, Xing Lina, Wang Xin.
The previous releases of this document and the documents it replaces are as follows.
- It was first issued in 1997 as GB/T 16886.1-1997; first revised in 2001; and revised
for the second time in 2011.
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.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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