|
US$199.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 45481-2025: Silicone rubber compounds - Application for medical catheters
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 45481-2025 | English | 199 |
Add to Cart
|
3 days [Need to translate]
|
Silicone rubber compounds - Application for medical catheters
| Valid |
GB/T 45481-2025
|
PDF similar to GB/T 45481-2025
Basic data | Standard ID | GB/T 45481-2025 (GB/T45481-2025) | | Description (Translated English) | Silicone rubber compounds - Application for medical catheters | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | G35 | | Classification of International Standard | 83.060 | | Word Count Estimation | 10,179 | | Date of Issue | 2025-03-28 | | Date of Implementation | 2025-10-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 45481-2025: Silicone rubber compounds - Application for medical catheters---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.
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
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 45481-2025_English be delivered?Answer: Upon your order, we will start to translate GB/T 45481-2025_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of GB/T 45481-2025_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 45481-2025_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+ countriesQuestion 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 [email protected]. 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.
|