GB/T 35510-2017 English PDFUS$119.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 35510-2017: Determination of released-particle count for closures of butyl rubber Status: Valid
Basic dataStandard ID: GB/T 35510-2017 (GB/T35510-2017)Description (Translated English): Determination of released-particle count 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: 6,679 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 35510-2017: Determination of released-particle count 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.Determination of released-particle count for closures of butyl rubber ICS 11.040.20 G45 National Standards of People's Republic of China Butyl rubber closures - Determination of easy shedding (ISO 8871-3.2003, Elastomeric parts of parenterals and for services pharmaceuticaluse-Part 3. Determination of released-particlecount, 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 ForewordThis 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 8871-3.2003 "Parenteral medical devices with elastic parts Part 3. Release Particle count determination. " This standard and ISO 8871-3.2003 technical differences and the reasons are as follows. --- On the scope of this standard made with technical differences in the adjustment to adapt to China's technical conditions, the adjustment is reflected in the first 1 chapter "range". Remove the scope of the butyl rubber bottle cork easy to shed the causes and hazards of provisions, only Retained "This standard specifies the butyl rubber stopper rinse easy to fall off (visible and invisible particles) Determination. This standard does not provide for particulate pollution restrictions, which can be negotiated by manufacturers and users. This standard applies to butyl rubber The main material made of medical corks (hereinafter referred to as "corks") "; --- On the 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. ● GB/T 6682-2008 modified to adopt international standards instead of ISO 3696.1987. This standard made the following editorial changes. --- On the standard name, changed to "butyl rubber stopper easy to fall off determination." 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, Liu Hongwei, Wang Xiao Wei, Yang Han, Zheng Sanyang, Feng Lei, Cui Youyu, Gao Naidong, Wang Jinying, Luo Guilin. Butyl rubber closures - Determination of easy shedding1 ScopeThis standard specifies the butyl rubber stopper rinse easy to fall off (visible and invisible particles) determination. This standard is not provided Restrictions on particulate contamination, which may be negotiated between the manufacturer and the user. This standard applies to butyl rubber as the main material made of medical stopper (hereinafter referred to as "stopper").2 Normative referencesThe 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 6682-2008 laboratory analysis of water specifications and test methods (ISO 3696.1987, MOD)3 visible particle number determination3.1 principle This method is by counting the number of particles in the bottle stopper rinse to assess the degree of contamination of its surface. 3.2 classification According to the purpose of this test, the longest dimension as a parameter, the particles are classified as follows. --- Class I. > 25μm and ≤50μm; --- Class Ⅱ > 50μm and ≤100μm; --- Class Ⅲ. > 100μm. 3.3 instruments and materials 3.3.1 Oscillator, do horizontal circular motion of diameter (12 ± 1) mm, speed is 300r/min ~ 350r/min. 3.3.2 membrane filter, the maximum aperture of 0.8μm, the surface is provided with 3mm × 3mm square grid lines. Note. Filter colors can significantly affect the test results. Unless otherwise specified, the basic color of the filter shall be medium gray and the range of coordinates in the CIE (International Commission on Illumination) system as follows. L * .60% ~ 70%; a * .- 4.7% ~ -3.7%; b * .- 4.7% ~ -3.7%. These rules apply to filters with a green 3 mm square mesh stamped on the surface. 3.3.3 wide-mouth Erlenmeyer flask, clean, capacity of 300mL. 3.3.4 Rinse, dissolve 3 g of polysorbate 80 (Tween 80) in 10 L of purified water (Grade 1 or 2, see GB/T 6682-2008). 3.3.5 Apparatus with a terminal filter to provide a rinse at a suitable pressure, with a maximum aperture of the terminal filter of 1.2 μm. 3.3.6 microscope, magnification × 50 or so, in the stage angle of 0 ° ~ 10 ° direct illumination. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 35510-2017_English be delivered?Answer: Upon your order, we will start to translate GB/T 35510-2017_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. 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