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SN/T 0966-2011 English PDF

SN/T 0966: Historical versions

Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
SN/T 0966-2011319 Add to Cart 3 days Rules for the inspection for import and export of flusher Obsolete
SN/T 0966-2000279 Add to Cart 3 days Rules for the inspection of flusher for import and export Obsolete

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Basic data

Standard 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Older Standard (superseded by this standard): SN/T 0966-2000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

Foreword

This 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 flusher

1 Scope

This 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 references

The 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 storage

3 Terms and Definitions

The 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 Inspections

5.1 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.
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