GB/T 35511-2017 English PDF

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GB/T 35511-2017: Biological requirements and test methods for closures of butyl rubber
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Basic data

Standard ID: GB/T 35511-2017 (GB/T35511-2017)
Description (Translated English): Biological requirements and test methods for closures of butyl rubber
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: G45
Classification of International Standard: 11.040.20
Word Count Estimation: 10,179
Date of Issue: 2017-12-29
Date of Implementation: 2018-07-01
Regulation (derived from): National Standards Bulletin 2017 No. 32
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

GB/T 35511-2017: Biological requirements and test methods for closures of butyl rubber

---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 requirements and test methods for closures of butyl rubber ICS 11.040.20 G45 National Standards of People's Republic of China Butyl rubber stopper Biological performance requirements and test methods (ISO 8871-4.2006, Elastomeric parts of parenterals and for services pharmaceuticaluse-Part 4. Biological requirements and test methods, MOD) 2017-12-29 Posted 2018-07-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China China National Standardization Administration released

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the redrafted law to amend the use of ISO 8871-4.2006 "parenteral medical devices with flexible parts Part 4. Biological Performance requirements and test methods. " This standard and ISO 8871-4.2006 technical differences and the reasons are as follows. --- On the scope of this standard made a technical differences with the adjustment, the adjustment of the situation focused on the first chapter "range", the specific Adjust as follows. ● ISO 8871-4.2006 in "This standard specifies the biodegradable butyl rubber stopper requirements and test methods, The extraction process of butyl rubber medical corks refers to the operating guidelines for biological tests in the Pharmacopoeia and related standards. This standard Quasi-applicable to butyl rubber bottle stopper. "Amend to read" This standard specifies the requirements and biological properties of butyl rubber stopper experiment method. This standard applies to butyl rubber as the main material made of medical stopper (hereinafter referred to as "stopper") "; --- On normative references, this standard made a technical difference with the adjustment to adapt to China's technical conditions, adjust the situation Concentration reflected in the second chapter "Normative references", the specific adjustments are as follows. ● Removed USP; ● Note the same date with the international standard GB/T 16886.5-2003 instead of ISO 10993-5; ● Added GB/T 14233.2-2005, GB/T 16886.10-2005 and GB/T 16886.11-2011; --- On the request, as the domestic has on the cytotoxicity, intradermal reaction, systemic toxicity test method standards, therefore, for the convenience of standard Quasi-use, the standard made with technical differences in the adjustment, the adjustment of the situation focused on the fourth chapter "requirements", the specific Adjust as follows. ● bacterial endotoxin, the "endotoxin content should meet the requirements agreed with the supplier and the user, the unit is per ml extract Some endotoxin (EU/mL) or endotoxin (EU/cm2) contained per square centimeter of cork. Test method should be effective. Note Appendix A contains a test method used to determine bacterial endotoxin in extracts "to" according to Appendix A Bacterial endotoxin test, cork extract in the content of endotoxin should meet the supplier and user agreed requirements, the unit is Endotoxin (EU/mL) or endotoxin (EU/cm2) contained in a milliliters extract "(see 4.2); Cytotoxicity "shall be tested in accordance with Annex B. For performance assessment, refer to chapter 87 of the United States Pharmacopeia, Biological Response Tests, In vitro "to" test in accordance with annex B without cytotoxicity "(see 4.4.2); • Intradermal reactions that "shall be tested in accordance with Annex C. For performance assessment, refer to chapter 88 of the United States Pharmacopeia, Biological Response Tests, In vivo, intradermal test "was revised to" test according to Appendix C, there should be no intradermal reaction "(see 4.4.3); ● systemic toxicity, "should be tested in accordance with Appendix D. Performance evaluation, refer to Chapter 88 of the United States Pharmacopoeia" to "according to the appendix D should be tested without systemic toxicity "(see 4.4.4); --- On the appendix, according to the actual conditions of domestic laboratories, in order to facilitate the use of standards, this standard made a technical differences with the adjustment, The adjustment is concentrated in the appendix. ● Amend Appendix A informative appendix to normative appendix (see appendix A); ● "Test according to the method specified in the United States Pharmacopeia or European Pharmacopoeia" is amended to read "according to paragraph 4 of GB/T 14233.2 Test methods prescribed in Chapter "(see A.2); ● Modify the procedure in B.3 in Appendix B to "proceed according to the provisions of GB/T 16886.5-2003" (see B.3); ● The B.4 results expressed as "the results expressed and judgment, the results of evaluation and reporting according to GB/T 16886.5-2003 8.5 Prescribed "(see B.4); ● The C.3 step in Appendix C is revised to "according to GB/T 16886.10-2005 Chapter 6, Chapter 7 provisions OK "(see C.3); ● Modify C.4 result to "result evaluation and report, the result is evaluated according to 6.4.5.2 in GB/T 16886.10-2005, 7.4.6, the result report shall be carried out according to 6.4.5.3 and 7.4.7 in GB/T 16886.10-2005 "(see C.4); ● The preparation of D.3 extract in Appendix D was revised to "Preparation of extract according to the provisions of GB/T 16886.11-2011" (See D.3); ● Change D.4 to "Follow GB/T 16886.11-2011" (see D.4); ● The result of D.5 is modified to "result evaluation and report, the result is evaluated according to 5.3.2 of GB/T 16886.11-2011 The result is reported in 5.4 of GB/T 16886.11-2011 "(see D.5). This standard made the following editorial changes. --- The standard name was revised as "butyl rubber stopper biological requirements and test methods"; --- Removed references. This standard proposed by the China Petroleum and Chemical Industry Federation. This standard by the National Rubber and Rubber Products Standardization Technical Committee (SAC/TC35) centralized. This standard was drafted unit. China Chemical Zhuzhou Rubber Research Institute Co., Ltd., Shenzhen Medical Device Testing Center, the National Latex Quality Supervision and Inspection Center, Jiangyin Exit Inspection and Quarantine, Guangdong Kaiwei Detection Technology Co., Ltd. The main drafters of this standard. Deng Yizhi, Wang Xiaowei, Liu Hongwei, Xu Wei District, Tan Yunhua, Feng Lei, Cui Youyu, Gao Nandong, Luo Guilin, Wang Jinying. Butyl rubber stopper Biological performance requirements and test methods

1 Scope

This standard specifies the biological properties of butyl rubber stopper requirements and test methods. This standard applies to butyl rubber as the main material made of medical stopper (hereinafter referred to as "stopper").

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this article Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 14233.2-2005 Medical infusion, transfusion, injection apparatus test methods Part 2. Biological test methods GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test (ISO 10993-5.1999, IDT) GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. Stimulation and delayed-type hypersensitivity test (ISO 10993-10.2002, IDT) GB/T 16886.11-2011 Biological evaluation of medical devices - Part 11. Systemic toxicity tests (ISO 10993-11.2006, IDT)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Bacterial endotoxins bacterialendotoxins Gram-negative bacteria lipopolysaccharide. 3.2 Bioburden The total number of microorganisms that survive in the product and/or package. [GB/T 19973.1-2015, Definition 3.1] 3.3 Cytotoxicity Biological Response of Cultures in vitro to Cava Extract. 3.4 Intradermal reaction intracutaneoustoxicity Local reactions that occur when the cork extract is injected intradermally into the rabbit. 3.5 Systemic toxicity systemic The systemic response to the cork extract was injected into mice. ......

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