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YY/T 0886-2013: General requirements of disposable inserter for intrauterine devices
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0886-2013 | English | 259 |
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General requirements of disposable inserter for intrauterine devices
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YY/T 0886-2013
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Basic data | Standard 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
Foreword
This 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 requirements
1 Scope
This 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 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 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 Pharmacopoeia
3 Terms and Definitions
The 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 type
4.1 placer structure type
The basic structure of the place by placing the tube, and place the rods positioning block shown in Figure 1.
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