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YY 0877-2013Purse string needle(with suture) (English PDF)

荷包缝合针

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

October 21, 2013

Implementation date

October 1, 2014

Scope

YY 0877-2013 is the English-translated version of 荷包缝合针.

YY 0877-2013 is the Chinese pharmaceutical industry standard for the single-use purse string needle supplied with its suture, the curved needle used to place a purse string suture.

It specifies the terms and definitions, the structural types and the materials, the specification marking, the requirements, the test methods, the marking and instructions and the rules for packaging, transport and storage, covering the dimensions and the point, the strength and the ductility of the needle, the attachment of the suture and the force needed to pull it out, the corrosion resistance and sterility.

It applies to needles used in gastrointestinal and haemorrhoid surgery. Issued on 21 October 2013, it has applied since 1 October 2014.

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Document preview — YY 0877-2013

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

Foreword
1 Scope
2 Normative references
3 Terms and Definitions
4 Structure type and material

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

1 Scope

This standard specifies the use of disposable purse string suture needle terms and definitions, structural type and material, specification mark, requirements, test methods, Signs, instructions, packaging, transport and storage.

This standard is applicable for use as a molding purse string suture needle gastrointestinal surgery or hemorrhoids surgery.

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 4240-2009 stainless steel wire

GB/T 4340.1-2009 metal materials - Vickers hardness test - Part 1. Test methods

GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests

GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residuals

GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10.

YY 0043-2005 medical suture needle

YY/T 0149-2006 stainless steel medical equipment corrosion test methods

YY 0167-2005 non-absorbable surgical suture

YY/T 0171-2008 surgical instrument packaging, labeling and instructions for use Symbols - Part 1 YY/T 0466.1-2009 medical equipment used with medical device labels, labeling and information provided.

YB/T 5219-1993 medical suture needle wire People's Republic of China Pharmacopoeia (2010 edition) two

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 Purse molding

Purse string suture needle forming device (clamp) is guided through the tissue incision edges of the suture in the sewing evenly cut around and through Tightening the sutures through the formation of pockets.

Note. Appendix A gives a guide.

4 Structure type and material

4.1 Structure type

Purse-string suture needle from the needle and suture composed of two parts, the structure types and basic dimensions shall conform to Figure 1 and Table 1.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 0043-2016

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