GB/T 16886.6-2015 (GB/T 16886.6-2022 Newer Version) PDF English
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Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
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Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
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Biological evaluation of medical devices. Part 6: Tests for local effects after implantation
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BUY with any currencies (Euro, JPY, GBP, KRW etc.): GB/T 16886.6-2022 Newer version: GB/T 16886.6-2022
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GB/T 16886.6-2015: PDF in English (GBT 16886.6-2015) GB/T 16886.6-2015
GB
NATIONAL STANDARD OF THE
PEOPLE'S REPUBLIC OF CHINA
ICS 11.040.01
C 30
GB/T 16886.6-2015 / ISO 10993-6.2007
Replacing GB/T 16886.6-1997
Biological evaluation of medical devices - Part
6. Tests for local effects after implantation
(ISO 10993-6.2007, IDT)
ISSUED ON. DECEMBER 10, 2015
IMPLEMENTED ON. APRIL 1, 2017
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.
Table of Contents
Foreword ... 3
1 Scope ... 6
2 Normative references ... 7
3 Terms and definitions ... 7
4 Common provisions for implantation test methods ... 8
5 Test methods, general aspects ... 9
6 Test report ... 16
Annex A (Informative) General considerations regarding implantation periods and
tissue responses to degradable/resorbable materials ... 18
Annex B (Normative) Test methods for implantation in subcutaneous tissue ... 19
Annex C (Normative) Test method for implantation in muscle ... 22
Annex D (Normative) Test method for implantation in bone ... 24
Annex E (Informative) Examples of evaluation of local biological effects after
implantation ... 27
Bibliography ... 30
Foreword
GB/T 16886 consists of the following parts, under the general title Biological evaluation
of medical devices.
- Part 1. Evaluation and testing within a risk management system;
- 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 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;
- Part 19. Physico-chemical, morphological and topographical characterization of
materials;
- Part 20. Principles and methods for immunotoxicology testing of medical devices.
This Part is Part 6 of GB/T 16886.
This Part is drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces GB/T 16886.6-1997 “Biological evaluation of medical devices - Part
6. Tests for local effects after implantation”. Compared with GB/T 16886.6-1997, main
technical content changes are as follows.
- MODIFY the “Scope” by adding degradable and/or resorbable materials;
- MODIFY the relevant content of “Common provisions for implantation test
methods”, “evaluation and test report” and “implantation sample quantity of
implantation in muscle”;
- ADD “Test methods, general aspects”;
- ADD “Annex A, General considerations regarding implantation periods and tissue
responses to degradable/resorbable materials”;
- ADD “Annex E, Examples of evaluation of local biological effects after
implantation”.
This Part uses translation method to identically adopt ISO 10993-6.2007 “Biological
evaluation of medical devices - Part 6. Tests for local effects after implantation”.
Corresponding Chinese documents of the international document in the normative
reference of this Part are as follows.
GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1. Evaluation
and testing (ISO 10993-1.1997, IDT)
GB/T 16886.2-2000 Biological evaluation of medical devices - Part 2. Animal
welfare requirements (idt ISO 10993-2.1992)
GB/T 16886.11-1997 Biological evaluation of medical devices - Part 11. Tests for
systemic toxicity (idt ISO 10993-11.1993)
GB/T 16886.12-2005 Biological evaluation of medical devices - Part 12. Sample
preparation and reference materials (ISO 10993-12.2002, IDT)
GB/T 16886.16-2003 Biological evaluation of medical devices - Part 16.
Toxicokinetic study design for degradation products and leachables (ISO 10993-
16.1997, IDT)
This Part was proposed by State Food and Drug Administration.
This Part shall be under the jurisdiction of National Technical Committee on Biological
Biological evaluation of medical devices — Part 6.
Tests for local effects after implantation
1 Scope
This Part of GB/T 16886 specifies test methods for the assessment of the local effects
after implantation of biomaterials intended for use in medical devices.
This Part applies to materials that are.
- solid and non-biodegradable;
- degradable and/or resorbable;
- non-solid, such as porous materials, liquids, pastes and particulates.
The test specimen is implanted into a site and animal species appropriate for the
evaluation of the biological safety of the material. These implantation tests are not
intended to evaluate or determine the performance of the test specimen in terms of
mechanical or functional loading. This Part of GB/T 16886 may also be applied to
medical devices that are intended to be used topically in clinical indications where the
surface or lining may have been breached, in order to evaluate local tissue responses.
The local effects are evaluated by a comparison of the tissue response caused by a
test specimen to that caused by control materials used in medical devices of which the
clinical acceptability and biocompatibility characteristics have been established. The
objective of the test methods is to characterize the history and evolution of the tissue
response after implantation of a medical device/biomaterial including final integration
or resorption/degradation of the material. In particular for degradable/resorbable
materials the degradation characteristics of the material and the resulting tissue
response should be determined.
This Part does not deal with systemic toxicity, carcinogenicity, teratogenicity or
mutagenicity. However, the long-term implantation studies intended for evaluation of
local biological effects may provide insight into some of these properties. Systemic
toxicity studies conducted by implantation may satisfy the requirements of this Part of
GB/T 16886.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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