Valid

YY/T 0079-2016Metallic clip (English PDF)

医用金属夹

Preview PDF

This is a limited preview

Buy now to download the full PDF (24 pages)

Need quotation for your management?

Get a formal quotation for YY/T 0079-2016 in 30 minutes.

Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 23, 2016

Implementation date

January 1, 2017

Scope

YY/T 0079-2016 is the English-translated version of 医用金属夹.

YY/T 0079-2016 is the Chinese pharmaceutical industry standard for the metallic surgical clip, the clip applied to close a vessel or a duct.

It sets the types and the basic dimensions, the requirements, the test methods, the inspection rules, the marking, the operating instructions and the rules for packaging, transport and storage, covering the material and its corrosion resistance, the form and the finish of the clip, its closing and holding force, the retention on the tissue and the compatibility with its applier. Issued on 23 March 2016, it has applied since 1 January 2017.

Found what you need?

Document preview — YY/T 0079-2016

National Standard of the People's Republic of China

Replacing: YY/T 0079-2006

Issued by: National Medical Products Administration of the People's Republic of China

Foreword3
1 Scope5
2 Normative references5
3 Type and basic dimension6
4 Requirements7
5 Test methods9
6 Inspection rule12
7 Marking, operating instructions12
8 Packaging and Storage12

Foreword

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

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 follows.

-- 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.

1 Scope

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 requirements.

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

4 Requirements

4.3 Appearance

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.

4.6 Toughness

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 performance.

4.8 Corrosion resistance Metallic clip shall have good

corrosion resistance; it will not produce any corrosion trace after test.

4.9 Sterility

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 Test methods

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 Biocompatibility

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..

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

Referenced standards

Normative references

Editions of YY/T 0079

Edition	Title	Revision	Status
YY/T 0079-2016	Metallic clip	current edition	Current
YY/T 0079-2006	Metallic clip	previous edition	Superseded

This page sells the current edition, YY/T 0079-2016. Earlier editions are listed for reference only.

How to Download YY/T 0079-2016

1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.