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www.ChineseStandard.net Database: 189759 (19 Oct 2025)

YY 0877-2013 English PDF

US$399.00 · In stock
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YY 0877-2013: Purse string needle(with suture)
Status: Obsolete

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY 0877-2013	English	399	Add to Cart	3 days [Need to translate]	Purse string needle(with suture)	Obsolete	YY 0877-2013

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Basic data

Standard ID	YY 0877-2013 (YY0877-2013)
Description (Translated English)	Purse string needle(with suture)
Sector / Industry	Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard	C36
Classification of International Standard	11.040.30
Word Count Estimation	10,126
Quoted Standard	GB/T 4240-2009; GB/T 4340.1-2009; GB/T 16886.5-2003; GB/T 16886.7-2001; GB/T 16886.10-2005; YY 0043-2005; YY/T 0149-2006; YY 0167-2005; YY/T 0171-2008; YY/T 0466.1-2009; YB/T 5219-1993; People's Republic of China Pharmacopoeia (2010 edition) two
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: Disposable purse-string suture needles Terminology and definitions, structure type and material specifications marking, requirements, test methods, marking, manual, packaging, transportation and storage. This standard applies: Whe

YY 0877-2013: Purse string needle(with suture)

---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.
Purse string needle (with suture) ICS 11.040.30 C36 People's Republic of China pharmaceutical industry standards Purse-string suture needle 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. Please note that some of the content of this standard may involve patents. The standard release Institutions do not assume the responsibility to identify these patents. The standard surgical instrument by the National Standardization Technical Committee (SAC/TC94) and focal points. This standard was drafted. Shanghai Medical Devices (Group) Co., Ltd. Surgical Instrument Factory, Shanghai Medical Device detection, Changzhou City Condit Limited medical stapler. The standard unit of participation. Huaiyin Medical Devices Co., Ltd., Jiangsu Province Medical Device Testing. The main drafters of this standard. Liu Wei group, Songhe flower, Yu Guoan, Liu Meiying. Purse-string suture needle

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. irritation and delayed-type hypersensitivity test 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. pass With requirements 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 pursestring 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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