YY/T 0043-2016Medical suture needle (English PDF)

Foreword

This document was issued on 23 March 2016 by the China Food and Drug Administration, and has applied since 1 January 2017.

It is a YY/T standard: a recommended industry standard of China's pharmaceutical and medical device sector.

It replaces YY 0043-2005 and YY 0666-2008.

1 Scope

This standard specifies the classification, designation and materials, requirements, test methods, inspection rules, packaging, marking, instructions for use and storage of medical suture needles.

This standard applies to medical suture needles (hereinafter referred to as suture needles) used for suturing internal organs, soft tissues, skin and the like.

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 4240, Stainless steel wires

GB/T 4340.1, Metallic materials - Vickers hardness test - Part 1: Test method

GB/T 16886.5-2003, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

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: Tests for irritation and delayed-type hypersensitivity

YY/T 0149-2006, Medical instruments of stainless steel - Test methods of corrosion resistance

YY 0167-2005, Non-absorbable surgical suture

YY/T 0171-2008, Surgical instruments - Packaging, marking and instructions for use

Pharmacopoeia of the People's Republic of China (Volume II), 2010 Edition

3 Classification, designation and materials

3.1 Suture needles are delivered in two states: sterile and non-sterile.

3.2 The forms, curvatures and eyes of suture needles are shown in Annex A.

3.3 The form, curvature, eye and size of a suture needle may be designated by the following symbols or in words: form - round, equilateral triangle, inverted triangle, short-blade triangle, triangular half-curved, and so on, each with its symbol.

3.4 Materials: suture needles are made of 30Cr13, 40Cr13, 12Cr18Ni9 or 06Cr19Ni10 as specified in GB/T 4240, or of other materials meeting the requirements of this standard.

4 Requirements

4.1.1 Needle body: the surface of the needle shall be smooth and uniform in colour; the point shall have no hook; the eye and groove shall be smooth and centred, without burrs or obvious skew. Once the needle is attached to the suture, the needle tail shall be smooth and free of burrs.

4.2.1 Hardness: the hardness of the needle shall meet the requirements of Table 1.

4.2.2 Elasticity: the needle shall have good elasticity.

4.2.3 Toughness: the needle shall have good toughness.

4.4 Bioburden: if the needle is supplied non-sterile, the initial bacterial contamination shall be not more than 100 CFU per needle.

4.7 Residual ethylene oxide: if the needle is sterilized with ethylene oxide, the residue shall be not greater than 10 µg/g.

4.8.1 Cytotoxicity: the cytotoxicity reaction of the needle shall be not greater than grade 1.

5 Test methods

5.1.1 Needle body: examine with normal or corrected vision; the result shall meet 4.1.1.

5.1.2 Triangular cutting edge: examine with a 5x magnifier; the result shall meet 4.1.2.

5.2.1 Hardness: measure three points on the needle by the method of GB/T 4340.1 and take the arithmetic mean; the result shall meet 4.2.1.

5.2.4 Point strength and 5.3.1 piercing force: test by the method of Annex C; the results shall meet 4.2.4 and 4.3.1.

5.5 Corrosion resistance: test by the boiling water method of YY/T 0149-2006; the result shall meet 4.5.

5.6 Sterility: test by the sterility test of the Pharmacopoeia of the People's Republic of China (2010 Edition, Volume II); the result shall meet 4.6.

6 Inspection rules

6.1 The items and sample sizes of the type inspection are given in Table 6.

6.2 Every item of the type inspection shall pass. If an item fails, a double sample is taken for that item and re-inspected, and all shall pass.

7 Packaging, marking and instructions for use

7.1.1 The single sterile package of the needles shall keep them sterile throughout the storage period.

7.2 The package shall carry at least the material designation and the markings specified in 3.3.

7.3 Instructions for use shall follow Clause 5 of YY/T 0171-2008, except for model and specification.

8 Storage

Packed suture needles shall be stored in a clean, well-ventilated room with a relative humidity of not more than 80 % and free of corrosive gases, and shall not rust within one and a half years.