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GB/T 45481-2025: Silicone rubber compounds - Application for medical catheters
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GB/T 45481-2025: Silicone rubber compounds - Application for medical catheters

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GB/T 45481-2025 English version. Silicone rubber compounds - Application for medical catheters ICS 83.060 CCSG35 National Standard of the People's Republic of China Silicone rubber compound for medical catheters Released on 2025-03-28 2025-10-01 Implementation State Administration for Market Regulation The National Standardization Administration issued

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the right to identify patents. This document was proposed by the China Petroleum and Chemical Industry Federation. This document is under the jurisdiction of the National Technical Committee on Rubber and Rubber Products (SAC/TC35). This document was drafted by. Jiangxi Bluestar Spark Organic Silicone Co., Ltd., Yongxiu County Inspection and Testing Center (Jiangxi Organic Silicone Product Quality Supervision Center Supervision and Inspection Center), Guangdong Yikang Medical Equipment Co., Ltd., Dongguan Zhengan Silicone Technology Co., Ltd., Dongguan Ruixiang Precision Silicone Products Co., Ltd., Jinan Chensheng Medical Technology Co., Ltd., Henan Jianqi Medical Equipment Co., Ltd., Dongguan Pinsheng Silicone Technology Co., Ltd. Dongguan Nanju Polymer Materials Co., Ltd., Shenzhen Baoan Medical Supplies Co., Ltd., Guangzhou Ruipai Medical Equipment Co., Ltd., Shenyang Rubber Research and Design Institute Co., Ltd. The main drafters of this document are. Yu Liang, Gao Hongkai, Wu Hong, Wu Chaobo, Chen Hao, Liao Quangen, Zhao Lingzhi, Liang Zhijun, Ren Baolai, Chen Sanling, Luo Hongkun, Xu Yannan, Wu Hao, He Shaofeng, and Liu Jiaxin. Silicone rubber compound for medical catheters

1 Scope

This document specifies the naming, technical requirements, inspection rules and marking, packaging, transportation and storage of silicone rubber compounds for medical catheters. The corresponding test methods are described. This document applies to the preparation of silicone rubber compounds (hereinafter referred to as compounds) for temporary and short-term contact medical catheters. Note. According to the "Medical Device Classification Rules", the medical catheters in this document belong to Class II medical devices.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB/T 528 Determination of tensile stress-strain properties of vulcanized rubber or thermoplastic rubber GB/T 529 Determination of tear strength of vulcanized rubber or thermoplastic rubber (trouser-shaped, right-angled and crescent-shaped test specimens) GB/T 531.1 Test method for indentation hardness of vulcanized rubber or thermoplastic rubber Part 1.Shore hardness tester method (Shore hardness) GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process GB/T 16886.5 Biological evaluation of medical devices Part 5.In vitro cytotoxicity test GB/T 16886.6 Biological evaluation of medical devices Part 6.Local reaction test after implantation GB/T 16886.10 Biological evaluation of medical devices Part 10.Skin sensitization test GB/T 16886.11 Biological evaluation of medical devices Part 11.Systemic toxicity tests GB/T 28112 Determination of volatile methylcyclosiloxane residues in silicone rubber GB/T 32365 Classification and systematic nomenclature of silicone rubber compounds

3 Terms and definitions

There are no terms or definitions that require definition in this document.

4 Naming

According to the provisions of GB/T 32365, silicone rubber is named by category code, hardness and use symbol. Example. A silicone rubber compound for medical catheters with a hardness of 40 Shore A is named. VMQ40-M VMQ 40-M Silicone rubber category code hardness Medical type ...