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YY/T 0183-2013 English PDF

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YY/T 0183-2013: Intra-uterine device lay-up fork
Status: Valid

YY/T 0183: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0183-2013English209 Add to Cart 3 days [Need to translate] Intra-uterine device lay-up fork Valid YY/T 0183-2013
YY/T 0183-1994English199 Add to Cart 2 days [Need to translate] intrauterine device layup fork Obsolete YY/T 0183-1994

PDF similar to YY/T 0183-2013


Standard similar to YY/T 0183-2013

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Basic data

Standard ID YY/T 0183-2013 (YY/T0183-2013)
Description (Translated English) Intra-uterine device lay-up fork
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C36
Classification of International Standard 11.200
Word Count Estimation 9,910
Older Standard (superseded by this standard) YY/T 0183-1994
Quoted Standard GB/T 1220; GB/T 2828.1; GB/T 2829; GB/T 4340.1; GB/T 4423; GB/T 6463; GB/T 9969; GB/T 10610; YY 0076-1992; YY/T 0149-2006; YY 0466.1; YY/T 1052
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 the IUD placement fork (hereinafter referred to as the placement fork) structure type, requirements, test methods, inspection rules, signs and instructions, packaging, transportation and storage. This standard applies to IUD placem

YY/T 0183-2013: Intra-uterine device lay-up fork

---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.
Intra-uterine device lay-up fork ICS 11.200 C36 People's Republic of China pharmaceutical industry standards Replacing YY/T 0183-1994 IUD placement fork 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. Instead of the standard YY/T 0183-1994 "IUD placement fork." This standard is in the original standard YY/T 0183-1994 The main technical differences. --- Range added "This standard does not apply to disposable IUD placement fork"; --- Increased 3.2 GB/T 1220 provisions of stainless steel; --- Increased 4.1.3 Test Method firmness of the stem portion and the shank portion is connected; --- Revised 4.3 and the outer surface of the surface roughness value "0.2μm" to "0.4μm"; --- Increase the corrosion resistance of the product performance requirements and test methods; --- Increased 6.4 Periodic inspection content. Please note that some of the content of this standard may involve patents, the issuing authority of this standard does not assume the responsibility to identify these patents. This standard by the national family planning equipment Standardization Technical Committee (SAC/TC169) and focal points. Drafting of this standard. Shanghai medical suture needle Co., Ltd., Shanghai State Food and Drug Administration Medical Devices Quality supervision Governor Inspection Center. The main drafters of this standard. Yuguo En, Yaotian Ping, Jin Yaoming, Wengbing Hao. The standard standard replaces the previous editions. --- GB 8579-1988; --- YY/T 0183-1994. IUD placement fork

1 Scope

This standard specifies the IUD placement fork (hereinafter referred to as placement fork) structure type, requirements, test methods, inspection rules, signs and Instructions, packaging, transportation and storage. This standard applies to IUD placement fork, place the O-products for gynecology and obstetrics, and similar shaped intrauterine IUD and correction IUD location purposes. This standard does not apply to disposable IUD placement fork.

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 1220 stainless steel rods 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 4340.1 Vickers hardness test - Part 1. Test methods GB/T 4423 copper and copper alloy rod drawing GB/T 6463 Metallic and other inorganic coating thickness - Measurement Methods GB/T 9969 General Instructions industrial products GB/T 10610 Geometrical product specifications (GPS) Surface texture Profile method - Rules and procedures for evaluation of the surface structure YY 0076-1992 metal parts coating technology classification conditions YY/T 0149-2006 stainless steel medical equipment corrosion test methods Symbols - Part 1 YY 0466.1 medical equipment used with medical device labels, labeling and information. General requirements YY/T 1052 surgical instruments logo

3 structure type

3.1 Place fork type, basic dimensions and limit deviations should meet the requirements of Figure 1. 3.2 Place the fork should be used GB/T 4423 specified in copper material or optional stainless steel materials GB/T 1220 regulations.

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