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YY 0092-2013Cervical biopsy forceps (English PDF)

子宫颈活体取样钳

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

October 21, 2013

Implementation date

October 1, 2014

Scope

YY 0092-2013 is the English-translated version of 子宫颈活体取样钳.

YY 0092-2013 is the Chinese pharmaceutical industry standard for the cervical biopsy forceps, the instrument that bites out a piece of cervical tissue for examination.

It specifies the structural type 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 cutting edges of the jaws, the cutting performance and the durability of the edge, the hardness and the corrosion resistance of the material, the joint and the handle, and the surface finish. Issued on 21 October 2013, it has applied since 1 October 2014.

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Document preview — YY 0092-2013

National Standard of the People's Republic of China

ICS
11.040.30
Classification
C 36
Replacing
YY 0092-1992

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 0092-1999 "Cervical vivo sampling clamp." The main technical differences between standard and original standard YY 0092-1999 follows.

--- Cancel the reference standard's number, and the reference standard is updated;

--- Increased use 30Cr13 clamp material, material requirements eliminated non-essential parts of the work;

--- Modify the "surface roughness arbitration using electrical measuring method" to "arbitration with the outline of Law";

--- Increasing the periodic inspection of the product.

1 Scope

This standard specifies the structure type cervical vivo sampling clamp and material requirements, test methods, inspection rules, marking, packaging, transport and Storage.

This standard applies to bite cut for cervical tissue for biopsy of the cervix with live sampling clamp (hereinafter referred to as biopsy forceps).

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 1911 copy paper

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 4340.1 metallic materials - Vickers hardness test - Part 1. Test methods

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 sampling clamp structure types and basic dimensions shall conform to Figure 1 and Table 1.

3.2 Material of the forceps

Sampling clamp clamp can be GB/T 1220 stipulated.

Note: may also be proven to be evaluated as safe and meet other requirements of this standard material.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.

Referenced standards

Similar standards

Editions of YY 0092

EditionTitleRevisionStatus
YY 0092-2013Cervical biopsy forcepscurrent editionCurrent
YY 0092-1992Cervical biopsy forcepsprevious editionSuperseded

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