GB/T 16886.10-2024 English PDF (GBT16886.10-2024)

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GB/T 16886.10-2024: Biological evaluation of medical devices - Part 10: Tests for skin sensitization
GB/T 16886.10-2024
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
Biological Evaluation of Medical
Devices – Part 10.Tests for Skin Sensitization
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.
This Document includes.
— details of in vivo skin sensitization test procedures;
— key factors for the interpretation of the results.
NOTE. Instructions for the preparation of materials specifically in relation to the above tests are given
in Annex A.
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.
ISO 10993-1 Biological evaluation of medical devices – Part 1.Evaluation and testing
within a risk management process
NOTE. 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)
ISO 10993-2 Biological evaluation of medical devices – Part 2.Animal Welfare
requirements
NOTE. GB/T 16886.2-2011 Biological evaluation of medical devices – Part 2.Animal Welfare
requirements (ISO 10993-2.2006, IDT)
ISO 10993-12 Biological evaluation of medical devices – Part 12.Sample preparation and
reference materials
NOTE. GB/T 16886.12-2023 Biological evaluation of medical devices – Part 12.Sample
There are two methods for preparing the test solution from the organic solvent extract.
Method 1 is applicable when the amount of residue obtained by solvent extraction of a test
sample and the weight of a test sample are relatively high because sufficient amounts of residue
have been obtained. In addition, Method 1 is especially recommended to evaluate the risk for
the medical devices which are repeatedly used. See Reference [14].
Method 2 is applicable when ...