YY 1024-2013Oviduct ligating hook (English PDF)
输卵管提取钩
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
October 21, 2013
Implementation date
October 1, 2014
Scope
YY 1024-2013 is the English-translated version of 输卵管提取钩.
YY 1024-2013 is the Chinese pharmaceutical industry standard for the oviduct ligating hook, the instrument with which the fallopian tube is drawn up during tubal ligation.
It specifies the types and the structure and the material, the requirements, the test methods, the inspection rules, the marking and the rules for packaging, transport and storage, covering the dimensions and the form of the hook, the smoothness of the surfaces and the absence of sharp edges, the strength and the elasticity of the instrument, the hardness and the corrosion resistance of the material, and the ability of the instrument to be cleaned and sterilized. Issued on 21 October 2013, it has applied since 1 October 2014.
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Document preview — YY 1024-2013
National Standard of the People's Republic of China
- ICS
- 11.040.30
- Classification
- C 36
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Structure type and material
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard replaces YY 91024-1999 "tubal extract the hook." This standard is in the original standard YY 91024-1999 main technical differences.
--- Cancel the reference standard's number, and the standard number of references to be updated;
--- Delete the original standard B Tubal extraction hook;
--- Remove the original standard icon Central Africa use parts of the size, delete the original standard shown in dimensional tolerances. Illustrating a main part Size expressed as ranges;
--- Modify the surface roughness in the original standard hook inside and at the weld.
1 Scope
This standard specifies the type and structure of the material extracted tubal hook (hereinafter referred to as the extraction hook), requirements, test methods, inspection rules, marking Chi, packaging, transport and storage.
This standard applies to time for the purposes of gynecological surgery for tubal ligation tubal extracted with fallopian tubes to extract the hook.
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.
GB/T 2829 periodic inspection Sampling procedures and tables (suitable for process stability test)
GB/T 10610 Geometrical product specifications (GPS) Surface texture Profile method - Rules and procedures for evaluation of the surface structure
YY/T 0149-2006 stainless steel medical equipment corrosion test methods
YY/T 1052 surgical instruments logo
3 Structure type and material
3.1 Structure type
Extraction hook Types and basic dimensions should comply with the requirements of Figure 1.
3.2 Material
Extraction hook can be used 12Cr13 or 12Cr18Ni9 materials GB/T 1220 stipulated.
Note: may also be proven to be evaluated as safe, other materials comply with the requirements of the standard.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 1220Stainless steel bars
- GB/T 2828.1Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
- GB/T 2829Sampling procedures and tables for periodic inspection by attributes
- GB/T 10610Geometrical product specifications (GPS) -- Surface texture: Profile method -- Rules and procedures for the assessment of surface texture
- YY/T 0149-2006Medical instruments of stainless steel - Test methods of corrosion resistance
- YY/T 1052Marking requirements for surgical instruments
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Related Standards
GB/T 10610-2009 — Geometrical product specifications (GPS) -- Surface texture: Profile method -- Rules and procedures for the assessment of surface texture
GB/T 1220-2007 — Stainless steel bars
GB/T 2828.1-2012 — Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
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YY 1024-2013
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