GB/T 16886.10-2024 PDF English
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Biological evaluation of medical devices - Part 10: Tests for skin sensitization
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Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
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Biological evaluation of medical devices -- Part 10: Tests for irritation and sensitization
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GB/T 16886.10-2024: Biological evaluation of medical devices - Part 10: Tests for skin sensitization---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/GBT16886.10-2024
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.100.20
CCS C 30
GB/T 16886.10-2024 / ISO 10993-10.2021
Replacing GB/T 16886.10-2017
Biological Evaluation of Medical Devices – Part 10.Tests for
Skin Sensitization
(ISO 10993-10.2021, IDT)
Issued on: AUGUST 23, 2024
Implemented on: SEPTEMBER 1, 2025
Issued by. State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 5
Introduction... 7
1 Scope... 10
2 Normative References... 10
3 Terms and Definitions... 11
4 General Principles - Step-Wise Approach... 13
5 Pretest Considerations... 14
5.1 General... 14
5.2 Types of material... 14
5.2.1 Initial considerations... 14
5.2.2 Ceramics, metals and alloys... 14
5.2.3 Polymers... 14
5.2.4 Biologically derived materials... 15
5.3 Information on chemical composition... 15
5.3.1 General... 15
5.3.2 Existing data sources... 15
6 Skin Sensitization Tests... 16
6.1 Choice of test methods... 16
6.2 Murine local lymph node assay... 17
6.2.1 Principle... 17
6.2.2 Test sample preparation... 17
6.2.3 Animals and husbandry... 18
6.2.4 Test procedure... 18
6.2.5 Treatment groups... 19
6.2.6 Determination of cellular proliferation and tissue preparation... 20
6.2.7 Results and interpretation... 20
6.2.8 Test report... 21
6.3 Guinea pig assays for the detection of skin sensitization... 21
6.3.1 Principle... 21
6.3.2 Choice of test sample concentrations... 21
6.3.3 Induction... 22
6.3.4 Challenge... 22
6.4 Important factors affecting the outcome of the test... 22
6.5 Guinea pig maximization test... 23
6.5.1 Principle... 23
6.5.2 Test sample preparation... 23
6.5.3 Animals and husbandry... 24
6.5.4 Test procedure... 24
6.5.5 Observation of animals... 28
6.5.6 Evaluation of results... 28
6.5.7 Test report... 28
6.6 Closed-patch test (Buehler test)... 29
6.6.1 Principle... 29
6.6.2 Test sample preparation... 29
6.6.3 Animals and husbandry... 29
6.6.4 Test procedure... 29
6.6.5 Observation of animals... 31
6.6.6 Evaluation of results... 31
6.6.7 Test report... 31
7 Key Factors in Interpretation of Test Results... 32
Annex A (Normative) Preparation of Materials for Skin Sensitization Testing... 33
A.1 General... 33
A.2 Materials for direct-contact exposure... 33
A.2.1 Solid test materials... 33
A.2.2 Liquid test materials... 33
A.3 Extracts of test materials... 33
A.4 Solvents... 34
A.5 Sterile test materials... 34
Annex B (Informative) Method for the Preparation of Extracts from Polymeric Test
Materials... 35
B.1 General... 35
B.2 Preparation method... 35
B.2.1 Preliminary extraction... 35
B.2.2 Final extraction... 35
B.3 Guinea pig maximization test... 37
B.3.1 General... 37
B.3.2 Challenge phase... 37
Annex C (Informative) Non-Animal Methods for Skin Sensitization... 38
C.1 Introduction... 38
C.1.1 Background on alternative methods for skin sensitization testing... 38
C.1.2 OECD’s adverse outcome pathway for skin sensitization... 38
C.1.3 Integrated approaches to testing and assessment... 40
C.2 In vitro assays for skin sensitization testing... 41
C.2.1 General... 41
C.2.2 Test methods... 41
C.3 Discussion... 49
C.3.1 OECD-validated assays... 49
C.3.2 Genomic assays... 50
C.3.3 Other assays... 50
C.3.4 General considerations for validation of in vitro methods for medical device testing
... 50
C.4 Conclusions... 51
Annex D (Informative) Background Information on Sensitization Tests for Skin
Sensitization... 52
Bibliography... 56
Foreword
This Document was drafted as per the rules specified in GB/T 1.1-2020 Directives for
Standardization – Part 1.Rules for the Structure and Drafting of Standardizing Documents.
This Document is Part 10 of GB/T (Z) 16886 Biological Evaluation of Medical Devices. GB/T
(Z) 16886 consists of 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 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 Leachable;
--- Part 17.Establishment of Allowable Limits for Leachable Substances;
--- Part 18.Chemical Characterization of Medical Device Materials within a Risk
Management Process;
--- Part 19.Physic-Chemical, Morphological and Topographical Characterization of
Materials;
--- Part 20.Principles and Methods for Immunotoxicology Testing of Medical Devices;
--- Part 22.Guidance on Nanomaterials;
--- Part 23.Tests for Irritation.
This Document replaced GB/T 16886.10-2017 Biological Evaluation of Medical Devices - Part
10.Tests for Irritation and Skin Sensitization. Compared with GB/T 16886.10-2017, the major
technical changes of this Document are as follows besides the structural adjustments and
editorial modifications.
a) Delete the content related to irritation test (see 3.6, 3.11, 3.16, 3.19, Clause 4, Clause 6 of
the 2017 Edition);
b) Add some terms and definitions (see 3.2, 3.4 of this Edition); and change some terms and
definitions (see 3.7, 3.14 of this Edition; 3.7, 3.16 of the 2017 Edition);
c) Change the procedures to be followed in the stimulation phase test; and add detailed
procedures (see 6.5.4.3.3 of this Edition; 7.5.4.3.3 of the 2017 edition).
This Document equivalently adopted ISO 10993-10.2021 Biological Evaluation of Medical
Devices – Part 10.Tests for Skin Sensitization.
Please note some contents of this Document may involve patents. The issuing agency of this
Document shall not assume the responsibility to identify these patents.
This Document was proposed by National Medical Products Administration.
This Document shall be under the jurisdiction of National Technical Committee 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; Sichuan University; and Jiangsu Institute of Medical
Device Testing.
Chief drafting staffs of this Document. Hou Li, Sun Lingxiao, Liang Jie, Yan Xiaoli, Jia Lifang,
Sun Xiaoxia, and Gao Jingxian.
The historical editions replaced by this Document are as follows.
--- GB/T 16886.10-2000 was first-time published in 2000; first-time revised in 2005;
second-time revised in 2017.
1 Scope
This Document specifies the procedure for the assessment of medical devices and their
constituent materials with regard to their potential to induce skin sensitization.
2 Normative References
The provisions in following documents become the essential provisions of this Document
through reference in this Document. For the dated documents, only the versions with the dates
indicated are applicable to this Document; for the undated documents, only the latest version
(including all the amendments) is applicable to this Document.
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)
GB/T 16886.2-2011 Biological evaluation of medical devices – Part 2.Animal Welfare
requirements (ISO 10993-2.2006, IDT)
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in ISO 10993-1 and the
following apply.
ISO and IEC maintain terminology databases for use in standardization at the following
addresses.
3.1 Allergen; Sensitizer
Substance or material that is capable of inducing a specific hypersensitivity reaction upon
repeated contact with that substance or material.
3.2 Allergic contact dermatitis
Clinical diagnosis based on an observed immunologically-mediated cutaneous reaction to a
substance.
4 General Principles - Step-Wise Approach
The available methods for testing sensitization were developed specifically to detect skin
sensitization potential. Other types of adverse effects are generally not predicted by these tests.
This document requires a step-wise approach, considering that any stage can result in the
conclusion that further testing for skin sensitization is not necessary.
5 Pretest Considerations
5.1 General
It is important to emphasize that pretest considerations can result in the conclusion that testing
for skin sensitization is not necessary.
The requirements given in GB/T 16886.1-2022, Clause 5, and the following apply.
In vivo, non-sterile samples shall be investigated by topical investigation only, as the possibility
of microbial contamination of the test sample can confound the final assay interpretation.
6 Skin Sensitization Tests
6.1 Choice of test methods
In vitro and in chemic alternative approaches have been developed for neat chemicals using a
combination of different assays to identify skin sensitizers.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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