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GB/T 16175-2008 English PDF

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Q: Should I purchase the latest version GB/T 16175-2008?

Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 16175-2008 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.

US$799.00 · In stock
Delivery: <= 6 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 16175-2008: Biological evaluation test methods for medical organic silicon materials
Status: Valid

GB/T 16175: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 16175-2008	799	Add to Cart	6 days	Biological evaluation test methods for medical organic silicon materials	Valid
GB/T 16175-1996	879	Add to Cart	6 days	Organic silicon material for medical use--Biological evaluation test methods	Obsolete

Similar standards

GB 16174.1 GB 16174.1 GB/T 16293 GB/T 21666

Basic data

Standard ID: GB/T 16175-2008 (GB/T16175-2008)
Description (Translated English): Biological evaluation test methods for medical organic silicon materials
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.100
Word Count Estimation: 36,312
Date of Issue: 2008-01-22
Date of Implementation: 2008-09-01
Older Standard (superseded by this standard): GB/T 16175-1996
Quoted Standard: GB/T 16886.1; GB/T 16886.3; GB/T 16886.5; GB/T 16886.6; GB/T 16886.10; GB/T 16886.11; GB/T 16886.12
Regulation (derived from): National Standard Approval Announcement 2008 No.2 (Total No.115)
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary: This standard specifies test methods for biological evaluation of medical silicone materials. This standard applies to biological evaluation of medical silicone materials.

GB/T 16175-2008: Biological evaluation test methods for medical organic silicon materials

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Biological evaluation test methods for medical organic silicon materials ICS 11.100 C30 National Standards of People's Republic of China Replacing GB/T 16175-1996 Biological evaluation of medical silicone materials Test Method Posted 2008-01-22 2008-09-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Preface Ⅰ Introduction Ⅱ 1 Scope 1 2 Normative references 1 3 Evaluation and Selection of tests 1 4 Sample Preparation 1 Test 5 Cytotoxicity 2 6 delayed-type hypersensitivity test 5 7 6 stimulation test 8 acute systemic toxicity test 7 9 Subacute (subchronic), and chronic systemic toxicity test 8 Pyrogen test 10 11 11 12 Genetic Toxicity Test 21 12 Implantation Trial Hemolysis test 13 23 Appendix A (informative) commonly used in cell culture and media preparation solution 25 Annex B (informative) genotoxicity tests with reagent preparation 27 References 31

Foreword

This standard replaces GB/T l6175-1996 "medical silicone Test method for evaluating biological material." This revision according to GB/T 16886 "Biological Evaluation of Medical Devices" for standard content has been modified and adjusted. This standard and GB/T 16175-1996 main differences are as follows. --- Increasing the normative references; --- Test Selection Guide to Evaluation and Selection of tests, test canceled the selection table; --- Modified material extract preparation, canceled the test surface area or weight of the extraction medium ratio table; --- Modify the cytotoxicity tests, including extracts and direct contact test; --- Allergy test is amended as delayed-type hypersensitivity test, increasing the closed sticking delayed-type hypersensitivity test; --- Will stimulate the skin test, primary skin irritation test and eye irritation test in order to stimulate the integration tests, including skin irritation test, eye Stimulation test and intradermal reaction test. Canceled the oral mucous membrane irritation test; --- Increased Subacute (subchronic), and chronic systemic toxicity test; --- Increased genotoxicity tests, including Salmonella typhimurium reverse mutation assay (Ames test), mouse lymphoma cell mutation Test and in vitro mammalian chromosome aberration test; --- Modified implant test, an increase of subcutaneous implants and bone test; --- Added Appendix B genotoxicity tests with reagent preparation. Appendix A of this standard and Appendix B is an informative annex. This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee on Biological evaluation of medical devices. This standard was drafted. State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center, Shanghai Biomaterials Research survey Test Center. This standard was mainly drafted by. Shaohua, Sun Jiao, Zhu Xuetao, said Huang Wei off, Huangjing Chun, Wang Xin, Li Hou, who next winter. This standard was first issued in March 1996.

Introduction

Test methods given in this standard is based on GB/T 16886.1. group "Biological evaluation of medical devices - Part 1 Evaluation and test" This principle, especially for biological evaluation of medical silicone material needs established. This revision is in GB/T 16886 "Medical Devices Biological Evaluation "standard and the" People's Republic of China Pharmacopoeia "(hereinafter referred to as" Chinese Pharmacopoeia ") two principles in the corresponding test methods and test 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) People's Republic of China Pharmacopoeia (two)

3 Evaluation and selection of tests

3.1 General Medical silicone materials according to desired properties and the contact time of contact with the body in accordance with the fundamental principles GB/T 16886.1 provisions were Biological evaluation. 3.2 Test selection GB/T 16886.1 is given an evaluation test to be considered. It may affect reproductive function of the body material should be added to make reproductive And developmental toxicity test.

4 Sample Preparation

4.1 General Preparation of test and control samples should be GB/T 16886.12 requirements. If the test program requires the use of the test material extraction Liquid extraction medium used and extraction conditions should feature and use the final product and test fit for purpose. Extraction conditions should be chosen in Consider the physical and chemical properties of the test material can be dissolved or residues. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of GB/T 16175-2008_English be delivered?

Answer: Upon your order, we will start to translate GB/T 16175-2008_English as soon as possible, and keep you informed of the progress. The lead time is typically 4 ~ 6 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of GB/T 16175-2008_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 16175-2008_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version GB/T 16175-2008?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 16175-2008 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.