GB/T 16886.10-2005 (GB/T 16886.10-2024 Newer Version) 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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GB/T 16886.10-2005: PDF in English (GBT 16886.10-2005) GB/T 16886.10-2005
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
C 30
GB/T 16886.10-2005 / ISO 10993-10.2002
Replacing GB/T 16886.10-2000
Biological evaluation of medical devices - Part 10.
Tests for irritation and delayed-type hypersensitivity
(ISO 10993-10.2002, IDT)
ISSUED ON. MARCH 23, 2005
IMPLEMENTED ON. DECEMBER 1, 2005
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of the People’s Republic of China;
Standardization Administration of the People’s Republic of
China.
3. No action is required - Full-copy of this standard will be automatically &
immediately delivered to your EMAIL address in 0~60 minutes.
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 7
4 General principles and evaluation procedure ... 10
5 Pretest considerations ... 11
6 Irritation tests ... 13
7 Delayed hypersensitivity tests ... 25
8 Key factors in interpretation of test results ... 33
Annex A (normative) Preparation of materials for irritation and sensitization
testing ... 35
A.1 General ... 35
A.2 Materials for direct-contact exposure ... 35
A.3 Extracts of test materials... 36
A.4 Solvents ... 36
A.5 Sterile test materials ... 36
Annex B (informative) Additional irritation tests ... 37
B.1 General ... 37
B.2 lntracutaneous reactivity test ... 37
B.3 Ocular irritation test ... 40
B.4 Oral mucosa irritation test ... 45
B.5 Penile irritation test ... 49
B.6 Rectal irritation test ... 52
B.7 Vaginal irritation test ... 54
Annex C (informative) Background information ... 58
C.1 Background information on irritation tests ... 58
C.2 Background information on sensitization tests for delayed hypersensitivity 59
Bibliography ... 63
Foreword
This Part of GB/T 16886 is identical to the international standard ISO 10993-10.2002
“Biological evaluation of medical devices - Part 10. Tests for irritation and delayed-type
hypersensitivity”.
This Part replaces GB/T 16886.10-2000, which has been technically revised. The main
revised contents are as follows.
- MODIFY “General principles and evaluation procedure”;
- ADD “Pretest considerations”;
- ADD “Irritation tests on human skin”;
- MODIFY “Delayed hypersensitivity tests”;
- PLACE “lntracutaneous reactivity test” and “Ocular irritation test”, which are in the
main body of the original standard, IN annex B, as the applicable irritation tests for
medical devices for specific portion;
- MODIFY the contents of annexes A and B of the original standard, the heading is
“Preparation of materials for irritation/sensitization testing”;
- MODIFY “Background information”;
- CANCEL annex C of the original standard.
GB/T 16886 consists of the following parts, under the general title “Biological
evaluation of medical devices”.
- Part 1. Evaluation and testing;
- 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 8. Selection and qualification of reference materials for biological tests;
- Part 9. Framework for identification and quantification of potential degradation
products;
- Part 10. Tests for irritation and delayed-type hypersensitivity;
- 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.
Future parts will deal with other relevant aspects of biological testing.
This Part is a harmonization of numerous standards and guidelines, including BS 5736,
OECD Guidelines, U.S. Pharmacopoeia and the European Pharmacopoeia. This Part
is the basic document for the selection and conduct of tests enabling evaluation of
irritation and dermal sensitization responses relevant to safety of medical materials
and devices.
Annex A is normative, and Annexes B and C are informative.
This Part is proposed by State Food and Drug Administration.
This Part is under the jurisdiction of National Technical Committee on Biological
Evaluation of Medical Devices of Standardization of China.
Drafting organization of this Part. State Food and Drug Administration - Jinan Quality
Supervision and Inspection Centre for Medical Devices.
Main drafters of this Part. You Shaohua, Qian Chengyu, Zhu Xuetao, Huang Jingchun,
Wang Xin, Wang Kelei.
Introduction
This Part assesses possible contact hazards from chemicals released from medical
devices that may produce skin and mucosal irritation, eye irritation and delayed contact
hypersensitivity
Some materials that are included in medical devices have been tested, and their skin
or mucosal irritation or sensitization potential has been documented. Other materials
and their chemical components have not been tested and may induce adverse effects
when in contact with biological tissues. The manufacturer is thus obliged to evaluate
each device for potential adverse effects prior to marketing.
Traditionally, small animal tests are performed prior to testing on humans to help
predict human response. More recently, in vitro tests as well as human tests have been
added as alternatives. Despite progress and considerable effort in this direction, a
review of findings suggests that currently no satisfactory in vitro test has been devised
to eliminate the requirement for in vivo testing. Where appropriate, the preliminary use
of in vitro methods is encouraged for screening purposes prior to animal testing. In
order to reduce the number of animals used, this Part presents a step-wise approach,
with review and analysis of test results at each stage. An animal test is usually required
prior to human testing.
It is intended that these studies be conducted using Good Laboratory Practice and
comply with regulations related to animal welfare. Statistical analysis of data is
recommended and should be used whenever appropriate.
The tests included in this Part of GB/T 16886 are important tools for the development
of safe products, provided that these are executed and interpreted by trained
personnel.
Biological evaluation of medical devices - Part 10.
Tests for irritation and delayed-type hypersensitivity
1 Scope
This Part of GB/T 16886 describes the procedure for the assessment of medical
devices and their constituent materials with regard to their potential to produce irritation
and delayed-type hypersensitivity.
This Part of GB/T 16886 includes
a) pretest considerations,
b) details of the test procedures, and
c) key factors for the interpretation of the results.
Instructions are given in annex A for the preparation of materials specifically in relation
to the above tests.
Supplementary tests which are required specifically for devices used intradermally in
the ocular, oral, rectal, penile and vaginal areas are given in annex B.
2 Normative references
The following normative documents contain provisions which, through reference in this
t...
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Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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