YY/T 1478-2016 English PDFUS$119.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1478-2016: Traceability information of disinfection and sterilization reusable medical devices Status: Valid
Basic dataStandard ID: YY/T 1478-2016 (YY/T1478-2016)Description (Translated English): Traceability information of disinfection and sterilization reusable medical devices Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C47 Word Count Estimation: 6,612 Date of Issue: 2016-07-29 Date of Implementation: 2017-06-01 Regulation (derived from): State Food and Drug Administration Notice 2016 (No.129) Issuing agency(ies): State Food and Drug Administration YY/T 1478-2016: Traceability information of disinfection and sterilization reusable 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. Traceability information of disinfection and sterilization reusable medical devices ICS 11.080.99 C47 People's Republic of China Pharmaceutical Industry Standard Reusable medical devices Disinfection of sterilization information 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued Directory Preface I 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 Reusable identification of medical devices 1 5 traceability of disinfection and disposal6 Traceability of sterilization treatment 2 7 Reusable management of medical device disinfection and sterilization retrospective information 3ForewordThis standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200) centralized. The main drafting of this standard. Shandong Xinhua Medical Devices Co., Ltd., Chengdu old Ken Technology Co., Ltd., the national food Commodity Supervision and Administration Guangzhou Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Zhang Qun, Yan Yunqi, Wang Hongmin, Hu Changming, Zhang Fan. Reusable medical devices Disinfection of sterilization information1 ScopeThis standard specifies the retrospective information necessary for the reusable medical device during the cleaning, disinfection and sterilization process. This standard does not apply to the retrospective information on the rest of the reusable medical device in the course of processing, such as recycling, classification, Storage and other content.2 normative reference documentsThe following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB 8599 large steam sterilizer technical requirements automatic control type GB/T 32309 Hydrogen peroxide low temperature plasma sterilizer YY 0503 Ethylene Oxide Sterilizer YY 0646 small steam sterilizer automatic control type YY/T 0679 Medical low temperature steam formaldehyde sterilizer YY/T 0734.1 Cleaning and disinfection - Part 1. General requirements, definitions and tests (YY/T 0734.1-2009, ISO 15883-1..2006, NEQ) YY/T 0802 Medical Device Sterilization Manufacturer Provides information on the treatment of reusable medical devices (YY/T 0802- 2010, ISO 17664..2004, IDT) YY 1007 vertical steam sterilizer YY 1275 hot air type dry heat sterilizer YY 0992 endoscopic cleaning station3 terms and definitionsThe following terms and definitions apply to this document. 3.1 Processing Preparations for new or used medical devices, including cleaning, disinfection and sterilization, to meet anticipated use requirements. [YY/T 0802-2010, definition 2.6] 3.2 Equipment package instrumentset In accordance with the purpose of combining and have a specific function of the complete sets of equipment and packaging of the general term.4 reusable medical device identification4.1 Information on reusable medical devices should be in accordance with YY/T 0802. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1478-2016_English be delivered?Answer: Upon your order, we will start to translate YY/T 1478-2016_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 1478-2016_English with my colleagues?Answer: Yes. 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