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YY/T 1031-2016 English PDF (YYT1031-2016)

YY/T 1031-2016 English PDF (YYT1031-2016)

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YY/T 1031-2016: Needle holders

This Standard specifies the classification, requirements, test methods, marking, packaging, storage and inspection rules of needle holders. This Standard is applicable to needle holders for holding suture needles for suturing skin, microvessels or tissues, etc.
YY/T 1031-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.30
C 31
Replacing YY/T 1031-2004
Needle Holders
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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 Classification ... 5
4 Requirements ... 9
5 Test Methods ... 11
6 Marking ... 13
7 Packaging and Storage ... 13
Appendix A (normative) Determination Method for Oscillating Quantity of Head End of Needle Holders ... 14
Appendix B (normative) Type Inspection ... 18
Needle Holders
1 Scope
This Standard specifies the classification, requirements, test methods, marking, packaging, storage and inspection rules of needle holders.
This Standard is applicable to needle holders for holding suture needles for suturing skin, microvessels or tissues, etc.
2 Normative References
The following documents are indispensable to the application of this document. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document.
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 Ellipsoid 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 Dial Gauges (dial and digital)
3 Classification
3.1 The needle holders are divided into: general needle holders, insert needle holders and microvascular needle holders.
the handle of the needle holders without cemented carbide inserts shall not be golden yellow. 4.3 Surface Roughness
The surface of the needle holders can be made with gloss or without gloss, and the value of the surface roughness parameter Ra shall not be greater than: with gloss: 0.4 ???m, without gloss: 0.8 ???m.
4.4 Elasticity and Firmness
4.4.1 The needle holders shall have good elasticity and firmness.
4.4.2 The connection between the cemented carbide inserts and the base of the insert needle holders shall be firm.
4.5 Clamping Performance
The needle holders shall have good clamping performance.
4.6 Tooth Contact
When the finger rings of the needle holders bump against each other, or when the locking teeth are all locked, no less than three-fifths of the tooth surface of the head serration shall be in contact.
4.7 Gill Flexibility
The opening and closing of the gill joints of the needle holders shall be flexible, and with appropriate tightness.
4.8 Oscillating Quantity
Disengage the locking teeth of the needle holders, and the head ends are separated by 1 mm. The oscillating quantity of the head end generated by the oscillating force applied to the ring part of the needle holders shall be not greater than that specified in Table 2. Table 2 -- Oscillating Quantity at the Head End
Unit: millimeter
4.9 Dimensions
The dimensions of the needle holders shall comply with the stipulations of ???1 and ???2 in Table 1. Total Length of Needle
Holder L
Oscillating Quantity
4.10 Hardness
4.10.1 The needle holders shall be subjected to thermal treatment, and their hardness shall comply with the stipulations of Table 3.
4.10.2 The hardness of the cemented carbide insert shall not be less than 923HV0.5; the difference between two pieces shall not be greater than 50HV0.5.
4.11 Corrosion Resistance
The corrosion resistance of the appearance of the needle holders shall not be lower than the stipulations of Grade-b in the boiling water test method in YY/T 0149-2006. 5 Test Methods
5.1 Appearance
Use normal or corrected vision to examine it and use hands to touch and feel it, which shall comply with the stipulations of 4.1.1 and 4.1.2.
5.2 Color Scale of the Handle
Use normal or corrected vision to examine it, which shall comply with the stipulations of 4.2. 5.3 Surface Roughness
The surface roughness of the needle holder shall be examined by the sample piece comparison method. Under the condition of magnification by 5 ~ 10 times, compare it with the sample piece, and use normal or corrected vision to examine it, which shall comply with the stipulations of 4.3.
5.4 Elasticity and Firmness
5.4.1 Place a stainless steel wire that complies with the stipulations of Table 4 on the front end of the head of the needle holder. The needle holder is completely closed, then loosened; repeat 3 times; observe the body of the instrument, which shall comply with the stipulations of 4.4.1. 5.4.2 After the insert needle holder is subjected to the elasticity and firmness test (5.4.1), observe the insert, which shall comply with the stipulations of 4.4.2.
5.5 Clamping Performance
At one third of the front end of the head of the needle holder, clamp the 3-0 Class I uncoated medical suture specified in YY 0167-2005; pull it hard, until the suture breaks; observe the clamped suture, which shall comply with the stipulations of 4.5.
5.6 Tooth Contact
Imitate the action of use, which shall comply with the requirements of 4.6. 5.7 Gill Flexibility
Imitate the action of use, which shall comply with the stipulations of 4.7. 5.8 Oscillating Quantity
Perform the test in accordance with the method specified in Appendix A, which shall comply with the stipulations of 4.8.
5.9 Dimensions
Use a general measuring instrument to measure them, which shall comply with the stipulations of 4.9.
5.10 Hardness
5.10.1 In accordance with the stipulations of GB/T 230.1-2009, determine the hardness. Respectively measure three points on each of the two pieces of the needle holder (except for the cemented carbide insert); respectively calculate the arithmetic mean, which shall comply with the stipulations of 4.10.1.
5.10.2 In accordance with the stipulations of GB/T 4340.1-2009, determine the hardness. Respectively measure three points on each of the two cemented carbide inserts; respectively calculate the arithmetic mean, which shall comply with the stipulations of 4.10.2. 5.11 Corrosion Resistance
Appendix A
(normative)
Determination Method for Oscillating Quantity of Head End of Needle Holders A.1 Terms
A.1.1 Oscillating quantity of head end
The head ends of the two pieces are separated by a specified position, and under the action of a specified force, the two pieces are oscillated relative to each other. Oscillating quantity of head end refers to the maximum displacement generated between the head ends of the two pieces. A.1.2 Fixing piece
The female piece of the needle holder.
A.1.3 Oscillating piece
The male piece of the needle holder.
A.1.4 Downward oscillating force
The force applied at the head end of the oscillating piece to oscillate the head end downward. A.1.5 Upward oscillating force
The force applied in the tooth socket of the ratchet of the oscillating piece (or near the root of the ring) to oscillate the head end upward.
A.2 Instrument Requirements
A.2.1 The measuring instrument for the oscillating quantity of the head end is composed of a dial indicator, a clamp for fixing the needle holder, a gill shaft supporting element, a measuring tool for the opening distance of the two head ends and an oscillating force element (see Figure A.1).

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