GB/T 16886.10-2024 PDF in English
GB/T 16886.10-2024 (GB/T16886.10-2024, GBT 16886.10-2024, GBT16886.10-2024)
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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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| GB/T 16886.10-2005 | English | 230 |
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Biological evaluation of medical devices -- Part 10: Tests for irritation and sensitization
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Biological evaluation of medical devices--Part 10: Tests for irritation and sensitization
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Standards related to (historical): GB/T 16886.10-2024
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GB/T 16886.10-2024: PDF in English (GBT 16886.10-2024) 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 the amount of residue obtained by solvent extraction of a test
sample or the weight of a test sample is relatively low. Examples of the latter are contact lenses
and intraocular lenses.
For both Methods 1 and 2, in parallel to the extraction of the test sample, the amount of solvent
equal to the total volume used during the extraction of the test sample is subjected to the same
concentration procedure as the test extracts. This solvent blank is used as negative control for
each phase of testing.
B.2.2.2 Test sample preparation according to Method 1
For Method 1, the extraction is performed by covering the test sample with a 10- to 20-fold
volume of the appropriate solvent (as determined in the preliminary extraction test) and
agitating (shaking) at room temperature. The solvent is collected in another flask. The solvent
is exchanged three times [e.g. after extraction for (4 ± 1) h, (8 ± 1) h or (24 ± 2) h] and repeated
to agitate at room temperature within a 24 h to 72 h period depending on the leaching and
stability of the substances extracted from the test material.
A residue is obtained by evaporating the collected solvent. A rotary evaporator is used at the
lowest possible temperature that provides controlled evaporation under reduced pressure.
The residue is dissolved in an appropriate vehicle (olive oil/acetone/ethanol/DMSO) as
determined by the solubility experiment in the preliminary extraction test, to prepare a mass
fraction of mass fraction of 10 % test solution for the intradermal induction phase and a mass
fraction of 20 % test solution for the intradermal induction phase and for the topical induction
phase in the GPMT.
For the challenge phase in the GPMT, a mass fraction of 10 % solution is prepared in the vehicle.
The 10 % solution is further diluted with the vehicle to obtain 1 %, 0.1 %, 0.01 % and 0.001 %
test solutions.
B.2.2.3 Test sample preparation according to Method 2
For Method 2, the extraction is performed by covering the test sample with a 10- to 20-fold
volume of the appropriate solvent (as determined in the preliminary extraction test) and shaking
at room temperature for (24 ± 2) h. The solvent is collected in one flask. The extraction
procedure is repeated three times within a 24 h to 72 h period using the same volume of fresh
solvent each time. The extracts are pooled in one flask and the solvent is evaporated.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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