YY/T 0886-2013 English PDFUS$259.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0886-2013: General requirements of disposable inserter for intrauterine devices Status: Valid
Basic dataStandard ID: YY/T 0886-2013 (YY/T0886-2013)Description (Translated English): General requirements of disposable inserter for intrauterine devices Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C36 Classification of International Standard: 11.200 Word Count Estimation: 11,155 Quoted Standard: GB/T 2828.1; GB/T 2829; B/GT 14223.1-2008; GB/T 16886.1; YY/T 0466.1 Regulation (derived from): State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall) Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies: IUD placer Terminology and definitions, structure type, requirements, test methods, inspection rules, marking, packaging, transportation and storage. This standard applies to: supporting the use of copper IUD placer. This standard YY/T 0886-2013: General requirements of disposable inserter for intrauterine 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.General requirements of disposable inserter for intrauterine devices ICS 11.200 C36 People's Republic of China pharmaceutical industry standards Disposable intrauterine device placer General requirements Issued on. 2013-10-21 2014-10-01 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 standard may involve patents. The standard release Institutions do not assume the responsibility to identify these patents. This standard by the national family planning equipment Standardization Technical Committee (SAC/TC169) and focal points. This standard was drafted. Weimin Wuhan Medical Devices Co., Ltd., Shanghai State Food and Drug Administration Medical Devices Quality supervision Governor Inspection Center, Liaoning love the mother in medical technology Co., Ltd. The main drafters of this standard. Sunxin Han, Yao Tianping, Shifeng Yang, Penning, Wengbing Hao, Li Ning. Disposable intrauterine device placer General requirements1 ScopeThis standard specifies the IUD placed the terms and definitions, structure type, requirements, test methods, inspection rules, marking, packaging, Transportation and storage. This standard applies to copper IUD placement is supporting the use of. This standard is not used to correct the position of the IUD or other Use or type of IUD placers.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. GB/T 2828.1 Sampling procedures for inspection - Part 1. by acceptance quality limit (AQL) retrieval batch inspection sampling plan GB/T 2829 periodic inspection Sampling procedures and tables (suitable for process stability test) GB/T 14233.1-2008 Infusion, transfusion, injection equipment - Part 1. Chemical analysis GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements People's Republic of China Pharmacopoeia3 Terms and DefinitionsThe following terms and definitions apply to this document. 3.1 IUD intra-uterinecontraceptivedevice Placed in a copper intrauterine device for avoiding pregnancy, but pregnant women's ability to recover after the removal of the instrument. 3.2 Placer inserter The IUD placed in the womb of the instruments used.4 structure type4.1 placer structure type The basic structure of the place by placing the tube, and place the rods positioning block shown in Figure 1. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0886-2013_English be delivered?Answer: Upon your order, we will start to translate YY/T 0886-2013_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 0886-2013_English with my colleagues?Answer: Yes. 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