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YY/T 0686-2017 English PDF (YYT0686-2017)

YY/T 0686-2017 English PDF (YYT0686-2017)

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YY/T 0686-2017: Medical forceps
This Standard specifies the classification, materials, requirements, test methods, inspection rules, marking, packaging, transportation and storage of medical forceps.
YY/T 0686-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.30
C 31
Replacing YY/T 0686-2008
Medical Forceps
ISSUED ON: MARCH 28, 2017
IMPLEMENTED ON: APRIL 1, 2018
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Classification ... 5
4 Materials ... 6
5 Requirements ... 7
6 Test Methods ... 8
7 Periodic Inspection ... 10
8 Marking ... 10
9 Instruction Manual ... 11
10 Packaging, Transportation and Storage ... 11
Appendix A (normative) Test Method for Amount of Deformation of Medical Forceps ... 12
Appendix B (normative) Test Method for Kneading Force ... 15
Appendix C (normative) Test Method for Connection Firmness ... 17
Medical Forceps
1 Scope
This Standard specifies the classification, materials, requirements, test methods, inspection rules, marking, packaging, transportation and storage of medical forceps. This Standard is applicable to reusable medical forceps for holding human tissues or dressings, which involve the following product categories:
---tissue forceps: for holding human tissues;
---thoracic forceps: for holding thoracic tissues;
---myocardial forceps: for holding myocardial tissues;
---brain forceps: for holding brain tissues;
---nasal forceps: for holding and separating nasal tissues;
---ear forceps: for holding and separating ear tissues;
---tumor removal forceps: for removing intracranial tumors;
---plastic surgery forceps: for holding human tissues;
---dressing forceps: for holding dressings.
This Standard is not applicable to medical forceps made of active and non-metallic materials. 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 1220-2007 Stainless Steel Bars
GB/T 1800.1-2009 Geometrical Product Specifications (GPS) - Limits and Fits - Part 1: Bases of Tolerances, Deviations and Fits
GB/T 3280-2007 Cold Rolled Stainless Steel Plate, Sheet and Strip
GB/T 3621-2007 Titanium and Titanium Alloy Plate and Sheet
Table 1 -- Manufacturing Materials of Medical Forceps
5 Requirements
5.1 Amount of Deformation
The medical forceps shall have good elasticity, and the amount of deformation shall not exceed 1.6 mm. The deformation of the dressing forceps shall not exceed 5% of the nominal length L, and the maximum deformation shall not exceed 10 mm.
5.2 Kneading Force
The kneading force of brain forceps, tumor removal forceps and myocardial forceps shall be within the range of 2 N ~ 8 N.
5.3 Connection Firmness
5.3.1 The connection between the two pieces of the medical forceps shall be firm. After the loading test, there shall be no separation, cracking or loosening.
5.3.2 The positioning pin of the medical forceps shall be firmly fixed. After the loading test, there shall be no loosening.
5.4 Matching
When the two pieces of the medical forceps are kneaded together, the teeth of the labial head shall match within 2/3 of its full length from the head end downwards; the hook and groove of the labial head hook shall match.
5.5 Coordination
If the medical forceps are equipped with a positioning pin, the coordination with the positioning hole shall be smooth and flexible.
5.6 Dimensions
The tolerances of the breadth b and thickness  (nominal dimensions) of the head end of the medical forceps shall comply with the stipulations of Level IT15 in GB/T 1800.1-2009. 5.7 Hardness
The medical forceps shall be subjected to the thermal treatment or cold-rolled treatment in accordance with the characteristics of the material, and the hardness shall comply with the Material Reference Standard
with the stipulations of 5.1.
6.2 Kneading Force
In accordance with the method specified in Appendix B, carry out the test, which shall comply with the stipulations of 5.2.
6.3 Connection Firmness
6.3.1 In accordance with the method specified in Appendix C, carry out the test, which shall comply with the stipulations of 5.3.1.
6.3.2 In the radial direction of the positioning pin, load a 5 N weight, after lasting for 15 s, check the hand feeling, which shall comply with the stipulations of 5.3.2. 6.4 Matching
Imitate the action of use, and use normal or corrected vision for inspection, which shall comply with the requirements of 5.4.
6.5 Coordination
Imitate the action of use, check the hand feeling, which shall comply with the stipulations of 5.5.
6.6 Dimensions
Use a general measuring instrument for measurement, which shall comply with the stipulations of 5.6.
6.7 Hardness
In accordance with the method in GB/T 4340.1, determine the hardness. Respectively measure three points on each of the two leaf springs of the medical forceps; take the arithmetic mean of the three points, which shall comply with the stipulations of 5.7.
6.8 Corrosion Resistance
In accordance with the boiling water test method specified in YY/T 0149-2006, carry out the test, which shall comply with the stipulations of 5.8.
6.9 Surface Roughness
Use normal or corrected vision, and under the condition of magnification by 5 times, in accordance with Figure 3, compare the medical forceps with the sample piece of surface roughness, which shall comply with the stipulations of 5.9.
6.10 Appearance
Use normal or corrected vision to examine it and use hands to touch and feel it, which shall comply with the stipulations of 5.10.
7 Periodic Inspection
The periodic inspection (type inspection) items of the medical forceps are the content of Chapter 5.
If there are no special stipulations, inspect 3 medical forceps for each item, which shall all be qualified.
8 Marking
8.1 In accordance with the stipulations of YY/T 1052-2004, each pair of medical forceps shall have at least the following markings on the instrument body:
a) The manufacturer’s code or trademark;
b) Material marking.
8.2 The packaging (minimum sales unit) shall have at least the following markings: a) The manufacturer’s name or trademark, and address;
b) Product name (or category name);
c) Specifications and models;
d) Quantity;
e) Production date and service life;
f) Production license No. (production archiving certificate No.);
g) Medical device registration certificate No. (archiving certificate No.). Appendix A
(normative)
Test Method for Amount of Deformation of Medical Forceps
A.1 Definition
The amount of deformation of the medical forceps refers to the difference between the natural recovery opening L2 and the natural opening L1 after changing the natural opening of the head of the medical forceps.
A.2 Instrument Requirements
A.2.1 The minimum indication value of the test instrument is 0.01 mm; the maximum measuring range is 300 mm.
A.2.2 The displacement speed of the test instrument is 200 mm/min ~ 300 mm/min. A.2.3 The maximum error of the test instrument is  0.08 mm.
A.3 Test Steps
A.3.1 Before the test, the medical forceps shall be cleaned of oil stains. A.3.2 Fix the head end of the lower piece (e) of the medical forceps on the clamp (c), and the tail end of the medical forceps shall naturally rest on the bracket (d); adjust the bracket, so that the head ends of the upper piece (a) and the lower piece (e) of the medical forceps are on the same vertical line; the medical forceps are in the state of natural opening, as it is shown in Figure A.1.
d---bracket (movable);
e---lower piece of the medical forceps.
Figure A.1 -- Natural State of Medical Forceps
A.3.3 Move the clamp (b) upward, until it comes into contact with the head end of the upper piece (a) of the medical forceps in the state of natural opening, then, immediately stop, and measure the value L1 of the natural opening of the medical forceps, as it is shown in Figure A.2. A.3.4 Fix the head end of the upper piece (a) of the medical forceps on the clamp (b); A.3.5 Move the clamp (b) upward, so that the head ends of the upper piece (a) and lower piece (e) of the medical forceps are opened to 50% of the nominal length L of the medical forceps; A.3.6 Move the clamp (b) downward, so that the upper piece (a) of the medical forceps returns to the position (natural opening L1 + 5% of nominal length L);
A.3.7 Repeat A.3.5 ~ A.3.6 for three times, as it is shown in Figure A.3; A.3.8 Loosen the head end of the upper piece (a) of the medical forceps on the clamp (b); A.3.9 Move the clamp (b) downward to separate the upper piece (a) of the medical forceps from the clamp (b), so that the medical forceps are in the state of natural opening; A.3.10 In accordance with the method of A.3.3, carry out the test; determine the value L2 of the natural recovery opening of the medical forceps.
Appendix B
(normative)
Test Method for Kneading Force
B.1 Definition
The kneading force of the medical forceps refers to the force required for the head end contact of the medical forceps.
B.2 Instrument Requirements
B.2.1 The minimum indication value of the test instrument is 0.01 N; the maximum measuring range is 20 N.
B.2.2 The loading speed of the test instrument is 60 mm/min ~ 80 mm/min. B.2.3 The maximum error of the test instrument is  0.1 N.
B.3 Test Steps
B.3.1 Before the test, the medical forceps shall be cleaned of oil stains. In addition, draw a centerline on the center of two pieces of the handle pattern of the medical forceps. B.3.2 As it is shown in Figure B.1, fix the handle pattern part of the upper piece (b) of the medical forceps on the clamp (a), so that the reference line on the clamp (a) coincides with the centerline of the handle pattern of the upper piece (b) of the medical forceps.
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