Standard No.:	YY/T 0079-2016
English Name:	Metallic clip
Chinese Name:	医用金属夹
Chinese Classification:	C36    Other special devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Issued by:	China Food and Drug Adminstration
Issued on:	2016-03-23
Implemented on:	2017-1-1
Status:	valid
Superseding:	YY/T 0079-2006 Implants for surgery -- Metallic clip
Language:	English
File Format:	PDF
Word Count:	5500 words
Price(USD):	120.0
Delivery:	via email in 1 business day

Metallic clip 1 Scope This standard specifies the types, basic dimensions, requirements, test methods, inspection rules, the requirements for marking, instructions for use, and packaging, transportation and storage of metallic clips. This standard is applicable to silver clips for clamping cerebral microvessels and titanium clips for clamping abdominal tubular tissues, hereinafter referred to as (metallic clips). 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 4135 Silver ingots GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1: Test method GB/T 6682 Water for analytical laboratory use - Specification and test methods GB/T 13810-2007 Wrought titanium and titanium alloy for surgical implants GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods GB/T 16886.3-2008 Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity GB/T 16886.6-1997 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation GB/T 16886.7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity GB/T 16886.11-2011 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance YY/T 0171-2008 Surgical instruments - Packaging, marking and instructions YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements YY/T 0597-2006 Clip applicator YY/T 0681.4 Test methods for sterile medical device package - Part 4: Detecting seal leaks in porous packages by dye penetration Pharmacopoeia of the People's Republic of China (2010 Edition, Volume II) 3 Type and basic dimensions 3.1 There are V-shaped and U-shaped metallic clips as the basic types, and their typical structures are shown in Figures 1 and 2. Note: These types of metallic clips are not unique.

Foreword I 1 Scope 2 Normative references 3 Type and basic dimensions 4 Requirements 5 Test methods 6 Inspection rules 7 Marking and instructions for use 8 Packaging and storage