YY/T 0043-2016 PDF English
US$260.00 · In stock · Download in 9 secondsYY/T 0043-2016: Medical suture needle Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid YY/T 0043: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 0043-2016 | English | 260 |
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Medical suture needle
| Valid |
| YY 0043-2005 | English | 559 |
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3 days
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Medical suture needle
| Obsolete |
| YY 0043-1991 | English | 439 |
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4 days
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Medical suture needle
| Obsolete |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: YY/T 0043-2016
YY/T 0043-2016: Medical suture needle---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0043-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.30
C 31
Replacing YY 0043-2005, YY 0666-2008
Medical suture needle
Issued on. MARCH 23, 2016
Implemented on. JANUARY 01, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative references... 5
3 Classification, labeling and materials... 6
4 Requirements... 7
5 Test method... 10
6 Inspection rules... 13
7 Packaging, marking and instructions for use... 13
8 Storage... 14
Appendix A (Informative) Schematic diagram of suture needle’s form, arc, hole
... 15
Appendix B (Informative) Schematic diagram of test device for elasticity and
toughness of suture needle... 16
Appendix C (Normative) Test method for piercing force and strength of needle
tip... 17
Appendix D (Normative) Test method for cutting force of suture needle’s triangle
edge... 21
1 Scope
This standard specifies the product classification, labeling and materials,
requirements, test methods, inspection rules, packaging, markings and
instructions for use and storage of medical suture needles.
This standard applies to medical suture needles (hereinafter referred to as
suture needles) used to suture internal organs, soft tissues, skin, etc.
2 Normative references
The following documents are essential to the application of this document. For
the dated documents, only the versions with the dates indicated are applicable
to this document; for the undated documents, only the latest version (including
all the amendments) are applicable to this standard.
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.Test
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
3 Classification, labeling and materials
3.1 Suture needles are divided into two delivery states. sterile and non-sterile.
3.2 See Appendix A for the form, arc, hole of the suture needle.
3.4 Materials
The suture needle is made of 30Cr13, 40Cr13, 12Cr18Ni9, 06Cr19Ni10
materials as specified in GB/T 4240, or other materials that meet the
requirements of the standard.
4 Requirements
4.1 Appearance
4.1.1 Needle body
The surface of the suture needle shall be smooth and uniform in color; the
needle tip shall have no hooks; the needle hole and needle groove shall be
smooth and centered; there shall be no burrs or obvious skew.
After the suture needle is connected to the suture thread, the needle tail shall
be smooth and free of burr.
4.2 Physical properties
4.2.1 Hardness
The hardness of the suture needle shall meet the requirements of Table 1.
4.2.2 Elasticity
The suture needle shall have good elasticity.
4.2.3 Toughness
The suture needle shall have good toughness.
4.4 Initial contamination bacteria
If the suture needle is not sterilized, the initial contamination of bacteria is less
than or equal to 100 CFU/piece.
4.7 Residual ethylene oxide
If the suture needle is sterilized with ethylene oxide gas, its residual amount
shall not be greater than 10 μg/g.
4.8 Biocompatibility
4.8.1 Cytotoxicity
The cytotoxicity test reaction of the suture needle is not greater than level 1.
5 Test method
5.1 Appearance
5.1.1 Needle body
Examination with normal or corrected vision shall meet the requirements of
4.1.1.
5.1.2 Inspection of triangular cutting edge
Observation with a magnifying glass of 5X shall meet the requirements of 4.1.2.
5.2 Physical properties
5.2.1 Hardness test
According to the method specified in GB/T 4340.1, measure three points on the
suture needle and take the arithmetic average value, which shall meet the
requirements of 4.2.1.
5.2.4 Tip strength test
According to the test method specified in Appendix C, it shall meet the
requirements of 4.2.4.
5.3 Performance
5.3.1 Piercing force test
According to the test method specified in Appendix C, it shall meet the
requirements of 4.3.1.
5.4 Initial contamination bacteria
5.5 Corrosion resistance
The corrosion resistance of the suture needle is tested according to the boiling
water test method of YY/T 0149-2006, the results shall meet the requirements
of 4.5.
5.6 Sterility
Carry out testing according to the Appendix XI H Sterile Test Method of the
People's Republic of China Pharmacopoeia" (2010 Edition · Part 2), the results
shall comply with the provisions of 4.6.
5.8 Biological evaluation
5.9 Packaging and marking
Observation with normal or corrected vision shall meet the requirements of 4.9.
6 Inspection rules
6.1 The items and sample size of type inspection are as shown in Table 6.
6.2 Judgment rules for type inspection
In the inspection, each inspection item shall be qualified. If other items are
unqualified, it shall take double number of sample of the unqualified items for
re-inspection, all shall be qualified.
7 Packaging, marking and instructions for use
7.1 Packaging
7.1.1 The sterilization single package of the suture needle shall be kept sterile
during the storage period.
7.2 Sign
The package of suture needles shall have at least the material designation, the
marking specified in 3.3, the following markings.
7.3 Instructions for use
It is performed according to the provisions of Chapter 5 (except model and
specifications) in YY/T 0171-2008.
8 Storage
The packed suture needles shall be stored in a clean and well-ventilated room
with a relative humidity of no more than 80%, no corrosive gas, no rust within
one and a half years.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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