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YY/T 0182-2013: Intra-uterine device removing hook
Status: Valid YY/T 0182: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0182-2013 | English | 209 |
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3 days [Need to translate]
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Intra-uterine device removing hook
| Valid |
YY/T 0182-2013
|
| YY/T 0182-1994 | English | 199 |
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2 days [Need to translate]
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intrauterine device removing hook
| Obsolete |
YY/T 0182-1994
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PDF similar to YY/T 0182-2013
Basic data | Standard ID | YY/T 0182-2013 (YY/T0182-2013) | | Description (Translated English) | Intra-uterine device removing hook | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C36 | | Classification of International Standard | 11.200 | | Word Count Estimation | 9,921 | | Older Standard (superseded by this standard) | YY/T 0182-1994 | | Quoted Standard | GB/T 1220; GB/T 2828.1; GB/T 2829; GB/T 4340.1; GB/T 4423; GB/T 6463; GB/T 9969; GB/T 10610; YY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 Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies: IUD removal hook (hereinafter referred to remove the hook) structure type, requirements, test methods, inspection rules, marking and instructions for use, packaging, transportation and storage. This standard applies to: IUD remova | YY/T 0182-2013: Intra-uterine device removing hook---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 removing hook
ICS 11.200
C36
People's Republic of China pharmaceutical industry standards
Replacing YY/T 0182-1994
IUD removal hook
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 0182-1994 "IUD removed the hook."
This standard is in the original standard YY/T 0182-1994 The main technical differences.
--- Increased 3.2 GB/T 1220 provisions of stainless steel;
--- Modified stem portion 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.
This standard was drafted. Shanghai Co., Ltd. medical suture needle, the State Food and Drug Administration of Quality Supervision, Inspection Shanghai Medical Devices
Test center.
The main drafters of this standard. Yuguo En, Yaotian Ping, Jin Yaoming, Wengbing Hao.
The standard standard replaces the previous editions.
--- GB 8580-1988;
--- YY/T 0182-1994.
IUD removal hook
1 Scope
This standard specifies the IUD removed the hook (hereinafter referred to as removing the hook) structure type, requirements, test methods, inspection rules, signs and
Manual, packaging, transportation, storage and so on.
This standard applies to the IUD removed the hook, the products for gynecology and obstetrics IUD (loop) purposes.
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 metallic materials - 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 Remove the hook structure type, basic dimensions and limit deviations should meet the requirements of Figure 1.
3.2 Remove the hook should be used GB/T 4423 specified in copper material or optional stainless steel materials GB/T 1220 regulations.
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