SN/T 0966-2011 English PDFSN/T 0966: Historical versions
Basic dataStandard ID: SN/T 0966-2011 (SN/T0966-2011)Description (Translated English): Rules for the inspection for import and export of flusher Sector / Industry: Commodity Inspection Standard (Recommended) Classification of Chinese Standard: C48 Word Count Estimation: 8,856 Date of Issue: 2011-05-31 Date of Implementation: 2011-12-01 Older Standard (superseded by this standard): SN/T 0966-2000 Quoted Standard: GB/T 14233.1-2008; GB/T 14233.2-2005; GB 15810; YY 0114; YY/T 0313 Regulation (derived from): National-Quality-Inspection-accreditation (2011) 291 Issuing agency(ies): General Administration of Customs Summary: This standard specifies the general requirements of the import and export washer, inspection, qualified critique given and deal with substandard inspection lot. This standard applies primarily to polyolefin material bolus medical disposable sterile and non-sterile disposable wash using irrigator. SN/T 0966-2011: Rules for the inspection for import and export of flusher---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.Rules for the inspection for import and export of flusher People's Republic of China Entry-Exit Inspection and Quarantine Standards Instead of the SN/T 0966-2000 Inspection of import and export flusher Issued on. 2011-05-31 2011-12-01 implementation People's Republic of China The State Administration of Quality Supervision, Inspection and Quarantine released ForewordThis standard was drafted in accordance with GB/T 1.1-2009 given rules. Instead of the standard SN/T 0966-2000 "washing the inspection of import and export." This standard SN/T 0966-2000 The main differences are as follows. --- Term corresponds with international standards; --- Modify the scope of regulations. --- Increased imports conformity assessment models; --- Increase unpacking inspection of test methods; --- Increasing the capacity tolerance test; --- Remove the pyrogen test, hemolysis test, abnormal toxicity test and performance test slide. 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 is proposed and managed by the National Certification and Accreditation Administration Committee. This standard was drafted. Jilin People's Republic of China Exit Inspection and Quarantine, Jilin Medical Device Testing. The main drafters of this standard. Song Yongli, Zhangxiao Xue, Yang Min, Li, Zhang Jingping, cotinine. This standard replaces the standards previously issued as follows. --- SN/T 0966-2000. Inspection of import and export flusher1 ScopeThis standard specifies the general requirements and export washer, inspection, qualified and unqualified criticism given process inspection lot. This standard applies primarily to polyolefin material bolus medical disposable sterile and non-sterile flushing disposable Irrigator.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 14233.1-2008 Infusion, transfusion, injection equipment - Part 1. Chemical analysis GB/T 14233.2-2005 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods GB 15810 single-use sterile syringes YY0114 Infusion, transfusion, syringes polyethylene Compound YY/T 0313 Medical Polymer Co., packaging, labeling, transportation and storage3 Terms and DefinitionsThe following terms and definitions apply to this document. 3.1 Flusher flusher Bolus medical disposable sterile and non-sterile wash disposable irrigator, for wound cleaning and disinfection. 4. Technical Requirements 4.1 Safety hygiene requirements The raw materials used should meet YY0114 standards, products should meet the standards of the medical device product registration product requirements. When applicable, Consider using national differences (region). 4.2 Other Requirements Which should conform to the special requirements of the relevant country (region) laws and regulations.5 Inspections5.1 Mode Select inspection and supervision 5.1.1 Flush uses imported conformity assessment mode. 5.1.2 The use of export washer type test mode. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of SN/T 0966-2011_English be delivered?Answer: Upon your order, we will start to translate SN/T 0966-2011_English as soon as possible, and keep you informed of the progress. The lead time is typically in 9 seconds (download/delivered in 9 seconds). The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of SN/T 0966-2011_English with my colleagues?Answer: Yes. 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Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version SN/T 0966-2011 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |