Standard No.:	GB/T 16175-2008
English Name:	Biological evaluation test methods for medical organic silicon materials
Chinese Name:	医用有机硅材料生物学评价试验方法
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	GB    National Standard
Source Content Issued by:	AQSIQ; SAC
Issued on:	2008-01-22
Implemented on:	2008-9-1
Status:	valid
Superseding:	GB/T 16175-1996 Organic silicon material for medical use-Biological evaluation test methods
Target Language:	English
File Format:	PDF
Word Count:	18000 words
Translation Price(USD):	540.0
Delivery:	via email in 1 business day

Biological evaluation test methods for medical organic silicon materials 1 Scope This standard specifies the biological evaluation test methods for medical organic silicon materials. This standard is applicable to the biological evaluation for medical organic silicon materials. 2 Normative references The following documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. For undated references, the latest edition of the normative document applies. GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing (GB/T 16886.1-2001, idt ISO 10993-1: 1997) GB/T 16886.3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (GB/T 16886.3-1997, idt ISO 10993-3: 1992) GB/T 16886.5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (GB/T 16886.5-2003, idt ISO 10993-5: 1999) GB/T 16886.6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (GB/T 16886.6-1997, idt ISO 10993-6: 1994) GB/T 16886.10 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (GB/T 16886.10-2005, ISO 10993-10: 2002, IDT) GB/T 16886.11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (GB/T 16886.11-1997, idt ISO 10993-11: 1993) GB/T 16886.12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (GB/T 16886.12-2005, ISO 10993-12: 2002, IDT) Pharmacopoeia of the People's Republic of China (Volume II) 3 Evaluation and test selection 3.1 General Medical organic silicon materials shall be subjected to biological evaluation in accordance with the basic principles specified in GB/T 16886.1, based on the nature and duration of their intended contact with the human body. 3.2 Test selection The evaluation tests that shall be considered are given in GB/T 16886.1. For materials that may affect the reproductive function of the body, additional reproductive and developmental toxicity tests shall be performed. 4 Sample preparation 4.1 General The preparation of test and control samples shall be performed according to GB/T 16886.12. If the test scheme requires the use of extracts of the test material, the extraction medium and extraction conditions used shall be appropriate to the properties and use of the final product, as well as to the purpose of the test. In selecting extraction conditions, consideration shall be given to the physico-chemical properties of the test material, as well as its leachable substances or residues.

Foreword i Introduction ii 1 Scope 2 Normative references 3 Evaluation and test selection 4 Sample preparation 5 Cytotoxicity test 6 Delayed-type hypersensitivity test 7 Tests for irritation 8 Acute systemic toxicity test 9 Subacute (subchronic) and chronic systemic toxicity tests 10 Pyrogen test 11 Genotoxicity test 12 Implantation test 13 Hemolysis test Annex A (Informative) Preparation of common solutions and media for cell culture Annex B (Informative) Preparation of reagents for genotoxicity tests Bibliography