YY/T 1031-2016 in English

Needle holders

1 Scope

This standard specifies the classification, requirements, test methods, markings, packaging, storage, and inspection rules for needle holders.

This standard is applicable to needle holders for holding suture needles for suturing skin, microvessels or tissues.

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 230.1-2009 Metallic materials - Rockwell hardness test - Part 1: Test method (scales A, B, C, D, E, F, G, H, K, N, T)
GB/T 1220-2007 Stainless steel bars
GB/T 4340.1-2009 Metallic materials - Vickers hardness test - Part 1: Test method
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
YY/T 0173-2010 Surgical instruments - Gill shaft, bolt and rivet
YY/T 0173.4-2005 Surgical instruments - Teeth, serration, ratchet and elliptoid ring
YY/T 0294.1-2005 Surgical instruments - Metallic materials - Part 1: Stainless steel
YY/T 1052-2004 Marking requirements for surgical instruments
JJ G 34 Verification regulation of dial gauges (dial and digital)

3 Classification

3.1 Needle holders are classified into: Needle holders for general use, insert needle holders, and microvascular needle holders.

3.2 The specifications, models and basic dimensions of the needle holders shall meet the requirements of Figures 1 to 3 and Table 1. Needle holders can be manufactured without serrations or ratchets.

3.3 The gill shafts of the needle holders may be selected according to the provisions of YY/T 0173-2010; and the serrations, ratchets, and elliptoid rings may be selected according to the provisions of YY/T 0173.4-2005.

3.4 Needle holders shall be manufactured using steel materials with grade B or C as specified in YY/T 0294.1-2005, or materials specified in GB/T 1220-2007 such as 20Cr13 and 30Cr13, or other stainless steel materials that comply with the requirements of Clause 4. The head ends of the needle holders may be inlaid with YG series cemented carbide materials.

Foreword I
1 Scope
2 Normative references
3 Classification
4 Requirements
5 Test methods
6 Marking
7 Packaging and storage
Annex A (Normative) Method for determining head-end swing of needle holders
Annex B (Normative) Type inspection