YY/T 0926-2014 English PDFUS$169.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0926-2014: Quantitative analysis of DEHP in PVC medical devices Status: Valid
Basic dataStandard ID: YY/T 0926-2014 (YY/T0926-2014)Description (Translated English): Quantitative analysis of DEHP in PVC medical devices Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C31 Classification of International Standard: 11.040.30 Word Count Estimation: 7,754 Date of Issue: 6/17/2014 Date of Implementation: 7/1/2015 Quoted Standard: PRC Pharmacopoeia 2010 edition (Volume 2) Adopted Standard: PRC Pharmacopoeia 2010 edition (Volume 2) Regulation (derived from): China Food and Drug Administration in 2014 Bulletin No. 30 Issuing agency(ies): State Food and Drug Administration Summary: This Standard applies to determination of DEHP content in the use of DEHP as a plasticizer of PVC medical medical devices. This Standard specifies the method of PVC medical devices DEHP content determination. First use of qualitative TLC, and then quantif YY/T 0926-2014: Quantitative analysis of DEHP in PVC medical devices---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.Quantitative analysis of DEHP in PVC medical devices ICS 11.040.30 C31 People's Republic of China pharmaceutical industry standards PVC medical devices phthalate Quantitative analysis (2-ethylhexyl) phthalate (DEHP) of Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released ForewordThis standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the National Standardization Technical Committee medical infusion apparatus (SAC/TC106) centralized. This standard was drafted. Shandong Medical Devices Product Quality Inspection Center. The main drafters of this standard. Kai Xu, Guo Lun Luo Hongyu.IntroductionBis (2-ethylhexyl) phthalate (DEHP) is the manufacture of medical devices polyvinyl chloride (PVC) material more commonly used plasticizer One agent. It can improve the cold resistance and the flexibility of plastic, lowering the softening temperature and improve the processing performance. The technical content of the standard reference to the 2010 edition of "European Pharmacopoeia" the relevant methods, test methods and general principles of a "People's Republic Pharmacopoeia "2010 edition. PVC medical devices phthalate Quantitative analysis (2-ethylhexyl) phthalate (DEHP) of1 ScopeThis standard gives a method of PVC medical devices DEHP content determination. First by TLC qualitative, then using UV spectrophotometry to quantify. Note. You can also use other suitable method, subject to the necessary verification methodology. This standard applies to the use of DEHP as a plasticizer in the manufacture of PVC medical devices.2 Normative referencesThe following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. People's Republic of China Pharmacopoeia 2010 Edition (two) Principle 3 Ether in a reflux condenser apparatus in a sample DEHP extraction, after extraction with toluene was evaporated to volume, with the "People's Republic of China And the National Pharmacopoeia "2010 edition two given TLC DEHP in the sample separated from other components and qualitatively, the sample is removed Reconstituted with ether, filtered and the filtrate evaporated with anhydrous ethanol content by UV spectrophotometry DEHP content.4 Reagents and Preparation of the solution4.1 ether AR. 4.2 Toluene AR. 4.3 ethanol AR. 4.4 DEHP standard Purity of not less than 99.0% (CAS number. 117-81-7). 4.5 DEHP reference solution (2mg/mL) Precision Weigh DEHP standard 20mg, dissolved and diluted with toluene to 10mL. 4.6 DEHP standard solution (2mg/mL) Precision Weigh DEHP standard 20mg, anhydrous ethanol dissolved and diluted to 10mL. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0926-2014_English be delivered?Answer: Upon your order, we will start to translate YY/T 0926-2014_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 YY/T 0926-2014_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0926-2014_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 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. |
