YY/T 1415-2016 English PDF

US$179.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1415-2016: Skin stapler
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1415-2016	179	Add to Cart	3 days	Skin stapler	Valid

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Basic data

Standard ID: YY/T 1415-2016 (YY/T1415-2016)
Description (Translated English): Skin stapler
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C36
Classification of International Standard: 11.040.30
Word Count Estimation: 9,961
Date of Issue: 2016-03-23
Date of Implementation: 2017-01-01
Regulation (derived from): Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies): State Food and Drug Administration

YY/T 1415-2016: Skin stapler

---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.
Skin stapler ICS 11.040.30 C36 People's Republic of China Pharmaceutical Industry Standard Skin stapler 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The release of this document The Agency does not assume responsibility for identifying these patents. This standard is proposed and centralized by the National Standardization Technical Committee for Surgical Instruments (SAC/TC94). The standard drafting unit. Changzhou City Kangdi medical stapler Co., Ltd., Shanghai Medical Devices Testing Institute. The main drafters of this standard. Yu Guoan, Weng Binghao. Skin stapler

1 Scope

This standard specifies the classification, requirements, test methods, type inspection rules, signs, instructions and use of disposable skin stapler Packaging, transportation and storage. This standard is applicable to disposable skin stapler for suturing cutaneous epidermal tissue during surgery (hereinafter referred to as " "Skin stapler").

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 223.1 ~ 223.83 Chemical analysis methods for steel and alloy (series) Stainless steel cold - rolled steel sheets and stripes GB/T Stainless steel for surgical implants GB/T 4234-2003 Stainless steel wire GB/T 4240-2009 Metallic materials - Vickers hardness test - Part 1. Test methods GB/T 4340.1-2009 GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residues GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. Stimulation and delayed type hypersensitivity test Test method for corrosion resistance of stainless steel medical equipment Surgical instrument packaging, marking and instruction manual YY/T 0171-2008 YY/T 0466.1-2009 Symbols for medical devices for labeling, labeling and providing information on medical devices Part 1. General Claim Test method for packaging of sterile medical devices - Part 4. Determination of the density of breathable packaging by dyeing solution penetration method YY/T 0681.4. Seal leaks Pharmacopoeia of the People's Republic of China (2010 edition and two)

3 classification

3.1 The type and basic dimensions of the skin stapler are shown in Figure 1 and Table 1. ......

Image     

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