SN/T 0966: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| SN/T 0966-2011 | English | 319 |
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Rules for the inspection for import and export of flusher
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SN/T 0966-2011
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| SN/T 0966-2000 | English | 279 |
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Rules for the inspection of flusher for import and export
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SN/T 0966-2000
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PDF similar to SN/T 0966-2011
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Count Estimation | 8,856 | | Date of Issue | 2011-05-31 | | Date of Implementation | 2011-12-01 | | Older Standard (superseded by this standard) | SN/T 0966-2000 | | Quoted Standard | GB/T 14233.1-2008; GB/T 14233.2-2005; GB 15810; YY 0114; YY/T 0313 | | Regulation (derived from) |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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