YY/T 0079-2016 English PDF (YYT0079-2016)
YY/T 0079-2016 English PDF (YYT0079-2016)
YY/T 0079-2016: Metallic clip
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Replacing YY/T 0079-2006
ISSUED ON. MARCH 23, 2016
IMPLEMENTED ON. JANUARY 1, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Type and basic dimension ... 6
4 Requirements ... 7
5 Test methods ... 9
6 Inspection rule ... 12
7 Marking, operating instructions ... 12
8 Packaging and Storage ... 12
This standard was drafted in accordance with the rules given in GB/T
This standard replaces YY/T 0079-2006 "Implants for surgery - Metallic clip". The main differences between this standard and YY/T 0079-2006 are as
-- Modify the name of the standard, which is changed from “Implants for surgery - Metallic clip” to “Metallic clip”;
-- Revise structure type and size requirements;
-- Revise material trademark and hardness range of titanium metal clip; -- Delete tantalum metal clip and related content;
-- Add clamping performance, corrosion resistance and package sealing
requirements and test methods;
-- Add microbiological indicators requirements and test methods;
-- Improve biocompatibility requirements and test methods.
Attention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by and shall be under the jurisdiction of National Surgical Instruments Standardization Technical Committee (SAC/TC94).
Main drafting organizations of this standard. Hangzhou Tonglu Medical Optical Instrument Factory, Shanghai Medical Equipment Testing Institute, Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd.
Participant organizations of this standard. Xinhua Surgical Instruments Co., Ltd.
Main drafters of this standard. ShentuYuhua, Zheng Qiang, Shi Wanxia, Huang Shuze, Yu Rong.
The previous versions of the standard replaced by this standard are.
This standard specifies many requirements related to metallic clip, such as type and basic dimension, requirements, test methods, inspection rules, marking, operating instructions, packaging, transport and storage
This standard applies to silver clip that clamps the capillaries of brain and titanium clip that clamps the abdominal tubular tissue. The following is referred to as (metallic clip).
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
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
The dimensions of metallic clip, including L1, L2, L3, shall comply with the provisions of 3.2.
4.3.1 Both sides of metallic clip shall be symmetric, and the appearance shall be smooth without any defects such as sharp edges, burrs, cracks, or spots. 4.3.2 The stripe and/or groove on metallic clip shall be clear and complete, and there shall be no overflow angle or sharp edges.
4.4 Surface roughness
The surface roughness parameter Ra of metallic clip shall not exceed 0.8 μm. 4.5 Hardness
The hardness of silver metallic clip is 60 HV0.1~100 HV0.1, and the hardness of titanium metallic clip is 100 HV0.2 ~ 200 HV0.2.
Metallic clip shall have good toughness and must not be cracked or broken after being clamped.
4.7 Clamping performance
Metallic clip and clamp are well-matched; it shall have good clamping
4.8 Corrosion resistance
Metallic clip shall have good corrosion resistance; it will not produce any corrosion trace after test.
If metallic clip is delivered in sterilized state, it shall undergo an effective and validated sterilization process to make the product sterile.
4.10 Microbiological indicators
If metallic clip is delivered in non-sterilized state, its initial contaminating bacteria shall be no more than 100 CFU/piece.
4.11 Ethylene oxide residual amount
If metallic clip is sterilized with ethylene oxide gas, the residual amount shall be no more than 10μg/g.
5.11 Ethylene oxide residual amount
Test according to the method specified in GB/T 16886.7, which shall comply with the provisions of 4.11.
Preparation of the test solution. metallic clip and test water are configured in a ratio of 1.0g. 5mL, sealed at a temperature of 60° C ±1° C, and balanced for 40 minutes.
5.12 Packaging seal test
Conduct a test according to the method specified in YY/T 0681.4, which shall comply with the provisions of 4.12.
5.13.1 Cytotoxicity test
Conduct a test according to the method specified in 8.2 (extract liquid test) of GB/T 16886.5-2003, which shall meet the requirements of 4.13.1.
5.13.2 Sensitization, intradermal reaction test
Conduct a test according to the methods specified in 7.4 (maximum dose test) and Appendix B (intradermal reaction test) of GB/T 16886.10-2005, which shall meet the requirements of 4.13.2 and 4.13.3.
5.13.3 Evaluation of systemic and sub-chronic toxicity
Evaluate according to the method specified in chapter 5 and chapter 6 of GB/T 16886.11-2011, which shall meet the requirements of 4.13.4 and 4.13.5.
5.13.4 Genetic toxicity evaluation
Evaluate according to the method specified in 4.4 of GB/T 16886.3-2008, which shall meet the requirements of 4.13.6.
5.13.5 Implantation reaction Evaluation
Evaluate according to the method specified in 3.4 of GB/T 16886.6-1997, which shall meet the requirements of 4.13.7.
5.13.6 Bacterial endotoxin
Evaluate according to the method specified in GB/T 14233.2-2005, which shall meet the requirements of 4.13.8..