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YY/T 0597-2006Clip Applicator (English PDF)

施夹钳

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 19, 2006

Implementation date

May 1, 2007

Scope

YY/T 0597-2006 is the English-translated version of 施夹钳.

YY/T 0597-2006 is the Chinese standard "Clip Applicator". Its scope clause reads: This standard specifies the types, basic dimensions, materials, requirements, test methods, inspection rules, as well as markings, packaging, transportation and storage for clip applicator.

This standard is applicable to surgical clip applicator. This product is used for clamping metal clips. Its clauses include types, basic dimensions, materials.

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Document preview — YY/T 0597-2006

National Standard of the People's Republic of China

ICS: 11.040.30
Replacing: YY 0079.3-1992

Issued by: National Medical Products Administration of the People's Republic of China

Foreword i
1 Scope
2 Normative references
3 Types, basic dimensions, materials
4 Requirements
5 Test method
6 Inspection rules
7 Marking
8 Packaging, transportation and storage

1 Scope

This standard specifies the types, basic dimensions, materials, requirements, test methods, inspection rules, as well as markings, packaging, transportation and storage for clip applicator.

This standard is applicable to surgical clip applicator. This product is used for clamping metal clips.

2 Normative references

The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections) to, or revisions, of any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition applies.

GB/T 230.1 Metallic rockwell hardness test - Part 1:Test method (scales A, B, C, D, E, F, G, H, K, N, T) (GB/T 230.1-2004, ISO 6508.1:1999, MOD)

GB/T 1220 Stainless steel bars (GB/T 1220-1992, neq JIS G4303:1988)

GB/T 2828.1 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (GB/T 2828.1-2003, ISO 2859-1:1999, IDT)

GB/T 2829 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability)

GB/T 14975 Stainless steel seamless tubes for structures

YY 0031-1990 Peritoneal dialysis catheters

YY 0079-2006 Implants for surgery - Metallic clip

YY/T 0149 Medical instruments of stainless steel - Test methods of corrosion resistance (YY/T 0149-2006, ISO 13402:1995, MOD)

YY 0167-2005 Non-absorbable surgical suture

YY/T 1052 Marking requirements for surgical instruments

3 Types, basic dimensions, materials

3.1

The type and basic dimensions of the clip applicator shall meet those specified in Figure 1, Figure 2, and Table 1.

3.2

The parts of clip applicator such as the forceps jaws, stem, or handle that come into contact with the human body shall be made of stainless steel materials such as 1Cr18Ni9Ti, 1Cr13, 2Cr13, and 3Cr13 as specified in GB/T 1220 and GB/T 14975.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

YY 0079-2006

Editions of YY/T 0597

Edition	Title	Revision	Status
YY/T 0597-2006	Clip Applicator	current edition	Current
YY 0079.3-1992	Clip Applicator	previous edition	Superseded

This page sells the current edition, YY/T 0597-2006. Earlier editions are listed for reference only.

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