YY/T 1761-2021 English PDFUS$219.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1761-2021: (Dialysis line disinfectant) Status: Valid
Basic dataStandard ID: YY/T 1761-2021 (YY/T1761-2021)Description (Translated English): (Dialysis line disinfectant) Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C45 Word Count Estimation: 10,123 Issuing agency(ies): State Drug Administration YY/T 1761-2021: (Dialysis line disinfectant)---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.(Dialysis line disinfectant) ICS 11.040.30 C45 People's Republic of China Pharmaceutical Industry Standard Dialysis tubing disinfectant Published on 2021-09-06 2023-03-01 Implementation Released by the State Drug Administration directory Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Classification and composition 1 5 raw material 1 6 Requirement 1 7 Test method 2 Appendix A (Informative Appendix) International Standard Example 4 Appendix B (Normative Appendix) Test Method for Citric Acid Content 5 Appendix C (Normative Appendix) Dialysis Machine Disinfection Simulation Field Test 6 forewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents. This standard is proposed by the State Drug Administration. This standard is under the jurisdiction of the National Standardization Technical Committee of Medical Extracorporeal Circulation Equipment (SAC/TC158). This standard was drafted. Guangdong Medical Device Quality Supervision and Inspection Institute. The main drafters of this standard. Liang Zexin, Yang Wenrun, Xu Suhua, Li Shengxia. Dialysis tubing disinfectant1 ScopeThis standard specifies the terms and definitions, classification and composition, raw materials, requirements and test methods of dialysis tubing disinfectant. This standard applies to the disinfectant with citric acid as the main component used for disinfection of the internal pipeline of the hemodialysis machine. This standard does not apply to the disinfection of the internal pipeline of the hemodialysis machine with peracetic acid, hypochlorous acid, hydrogen peroxide, etc. as the main components. venom.2 Normative referencesThe following documents are essential for the application of this document. 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. Pharmacopoeia of the People's Republic of China Technical Specification for Disinfection (2002 Edition)3 Terms and DefinitionsTerms and definitions defined in "Technical Specifications for Disinfection" (2002 Edition) apply to this document.4 Classification and compositionThe main active ingredient of dialysis pipeline disinfectant is citric acid, and some of them will add malic acid and lactic acid.5 raw materialsThe raw materials of the product should meet the requirements of the "Pharmacopoeia of the People's Republic of China" or international standards. Note. See Appendix A for international standards.6 Requirements6.1 Appearance There should be no visible foreign matter, and the color should not be darker than No. 3 yellow (or yellow-green) colorimetric solution. 6.2 Physical and chemical indicators 6.2.1 pH value Should comply with the manufacturer's specifications. 6.2.2 Loading capacity It should not be less than 98.5% of the marked loading. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1761-2021_English be delivered?Answer: Upon your order, we will start to translate YY/T 1761-2021_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 1761-2021_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1761-2021_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. |