GB/T 16175-2008Biological evaluation test methods for medical organic silicon materials (English PDF)
医用有机硅材料生物学评价试验方法
This is a limited preview
Buy now to download the full PDF (30 pages)
Need quotation for your management?
Get a formal quotation for GB/T 16175-2008 in 30 minutes.
Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
January 22, 2008
Implementation date
September 1, 2008
Scope
GB/T 16175-2008 is the English-translated version of 医用有机硅材料生物学评价试验方法.
GB/T 16175-2008 is the Chinese standard "Biological evaluation test methods for medical organic silicon materials". Its scope clause reads: 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. Its clauses include evaluation and test selection; sample preparation.
Found what you need?
Document preview — GB/T 16175-2008
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 30
- Replacing
- GB/T 16175-1996
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- 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
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 30 pages — is available in the English PDF.
Similar standards
Editions of GB/T 16175
| Edition | Title | Revision | Status |
|---|---|---|---|
| GB/T 16175-2008 | Biological evaluation test methods for medical organic silicon materials | current edition | Current |
| GB/T 16175-1996 | Biological evaluation test methods for medical organic silicon materials | previous edition | Superseded |
This page sells the current edition, GB/T 16175-2008. Earlier editions are listed for reference only.
How to Download GB/T 16175-2008
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
GB/T 10003-2026 — Biaxially oriented polypropylene (BOPP) film
GB/T 10004-2026 — Plastic/Plastic laminated films and pouches for packaging
GB/T 10007-2026 — Rigid cellular plastics - Determination of shear properties
Secure payment via Stripe
Payments accepted
GB/T 16175-2008
$525.00