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YY 0167-2005 English PDF (YY0167-2005)

YY 0167-2005 English PDF (YY0167-2005)

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YY 0167-2005: Non-absorbable surgical suture

This Standard specifies the classification, requirements, test methods, inspection rules, signs, instruction manual, packaging, transportation, and storage of non-absorbable surgical suture. This Standard applies to the non-absorbable surgical suture used in human tissue suture and ligation in medical operation.
YY 0167-2005
ICS 11.040.30
C 31
YY
Pharmaceutical Industry Standard
of the PEOPLE Republic of China
Replacing YY 0167-1998
Non-absorbable surgical suture
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ISSUED ON. JULY 18, 2005
IMPLEMENTED ON. JUNE 1, 2006
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Classification... 5
4 Requirements ... 6
5 Test methods ... 8
6 Inspection rules ... 12
7 Signs and instructions ... 14
8 Packaging, transportation and storage ... 16
Foreword
This Standard replaces YY 0167-1998 "Non-absorbable surgical suture".
The main differences between this Standard and YY 0167-1998 are as follows. - ADD the specifications of suture;
- ADD the corresponding metric specifications of suture;
- ADD the relevant requirements for needle;
- ADD the relevant requirements for ethylene oxide residue;
- MODIFY the test methods of biological evaluation.
This Standard was proposed and shall be administrated by National
Standardization Technical Committee of Surgical Instruments.
Main drafting organization of this Standard. Johnson and Johnson (China)
Medical Equipment Co., Ltd..
Main drafters. Ma Wenzhong, and Chen Hua.
The previous versions replaced by this Standard are.
- YY 0167-1989;
- YY 0167-1994;
- YY 0167-1998.
Non-absorbable surgical suture
1 Scope
This Standard specifies the classification, requirements, test methods, inspection rules, signs, instruction manual, packaging, transportation, and storage of non-absorbable surgical suture.
This Standard applies to the non-absorbable surgical suture (hereinafter referred to as suture) used in human tissue suture and ligation in medical operation.
2 Normative references
The provisions in following documents become the provisions of this Standard through reference in this Standard. For dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this Standard, however, parties who reach an agreement based on this Standard are
encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies. GB/T 9737-1988 Chemical reagent - General rules for the measurement of
readily carbonizable substances (eqv ISO 6353-1. 1982 GM18)
GB/T 14233.1-1998 Infusion, transfusion, injection equipment for medical use - Part 1. Chemical analysis methods
GB/T 14436 General principles of industrial product guarantee documents GB/T 16175-1996 Organic silicon material for medical use - Biological
evaluation test methods (eqv ISO 10993-2. 1993, idt ISO 10993-1. 1997)
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing (GB/T 16886. 1-2001, idt ISO 10993-1.1997)
GB/T 16886.3-1997 Biological evaluation of medical devices - Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity (idt ISO 10993-3. 1992)
GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10.
4.10.4 Genotoxicity
Gene mutation, structure and number of chromosome and the influence on
DNA (deoxyribonucleic acid), shall have not the reaction of toxicity change. 4.10.5 Implantation
The extent of reaction of inflammatory cells and the extent of formation of fiber cavity shall comply with the specifications of 13.6.2 in GB/T 16175-1996. 4.10.6 Sensitization
There shall not have sensitization.
5 Test methods
5.1 Appearance
OBSERVE visually or by means of quintuple magnifying glass under normal light. It shall comply with the specifications of 4.1.1, 4.1.2.
5.2 Wire diameter
5.2.1 Test equipment
Wire diameter measuring instrument. The minimum scale value is 0.002mm. The flatness of presser foot and datum plane is within 0.005mm, and in parallel to each other. The diameter of presser foot is within 10mm~15mm. The
diameter of datum plane shall not be less than the diameter of presser foot. The presser foot and the load on the suture is within 90g~210g.
5.2.2 Test procedure
5.2.2.1 TAKE out the suture from the package. Without tensile, it shall conduct the wire diameter measuring immediately. If the suture is packaged by liquid, the test must be completed within 2min after the suture is taken out from the liquid.
5.2.2.2 FIX one end of the suture on the wire diameter measuring instrument. At the same time, the other end of the suture shall be exerted with certain tension. The magnitude of tension is according to the specifications of suture. Take half of the tensile strength value of category ??? suture in table 3. For the metal suture, its maximum tension shall not be greater than half of the tensile Preparation of water extract of test material shall be conducted according to the specifications of 5.10.1.1. And it is tested according to the requirements of Chapter 11 in GB/T 16175-1996. It shall comply with the specifications of 4.10.2.
5.10.3 Cytotoxicity test
TEST according to the requirements of Chapter 4 in GB/T 416175-1996. It shall comply with the specifications of 4.10.3.
5.10.4 Sensitization test
Preparation of water extract of test material shall be conducted according to the specifications of 5.10.1.1. And it is tested according to the requirements of Chapter 6 in GB/T 16886.10-2000. It shall comply with the specifications of 4.10.4.
5.10.5 Genotoxicity test
Preparation of water extract of test material shall be conducted according to the specifications of 5.10.1.1. And it is tested according to the requirements of Chapter 4 in GB/T 16886.3-1997. It shall comply with the specifications of 4.10.4.
5.10.6 Implantation test
TEST according to the requirements of Chapter 13 in GB/T 16175-1996. It shall comply with the specifications of 4.10.6.
6 Inspection rules
6.1 Acceptance
The suture shall be inspected by the technical inspection department of manufacturer. And it shall ensure that the product quality meets the
requirements of this Standard, before it is submitted for acceptance.
6.2 Batch
The suture shall be submitted to inspect in batches. The inspection is divided into batch-by-batch inspection and periodic inspection.
An inspection batch can be constituted by a production batch. These
b) When the product formulation, process, primary packaging or sterilization is changed;
c) There is any change of final products during the period of storage;
d) There are signs indicating that the products might cause side effects when being used in human body.
Table 7 Items and sampling amount of periodic inspection
Inspection
items
4.1, 4.2, 4.3,
4.4, 4.6
4.5 4.7 4.8 4.9 7.1.1
Sampling
amount
5 strips 0.25g 3 strips
7 small
packages
2.0g
1 small
package
6.4.3 The inspection rules are the same as 6.3.2.
7 Signs and instructions
7.1 Signs
7.1.1 Each small packaging shall have the following signs.
a) Name, specifications and quantity of product. If the products are packaged by liquid, it shall indicate the components of packaging liquid;
b) Sterilization methods, the sign of disposable;
c) Production date or batch number;
d) Validity period;
e) Name of the manufacturer;
f) Words of "Sterility" and "Prohibition of use with damaged package" and so on;
g) When the small packaging is the minimum sale unit, it shall have the product registration certificate number of medical device.
7.1.2 The median packaging shall have the following signs.
a) Name of the manufacturer;
b) Name, trademark, specifications and quantity of product;
c) Product registration certificate number of medical device;
d) Sterilization methods, sign of disposable;
e) Production date or batch number;
7.2.2 The compilation of instruction manual shall comply with the specifications of State Food and Drug Administration's No.10 Decree.
8 Packaging, transportation and storage
8.1 Packaging
8.1.1 The small packaging shall be the minimum packaging for disposable. The products after being processed by sterilization can be stored by dry method. It can be also packaged by liquid. The storage containers and boxes shall be designed reasonably, so to maintain the sterility of product until the package is opened.
8.1.2 The packaging for sale shall have double packaging protections.
8.1.3 The packaging of product shall have the following documents or signs. a) Instruction manual;
b) Product certification or quality guarantee. The writing of product certification shall comply with the specifications of GB/T 14436.
8.2 Transportation
The products shall be prevented from the heavy-pressure, direct sunlight and rain. Or it may be according to the specifications of contract.
8.3 Storage
The products shall be stored at cool, dry, clean, well-ventilated environment and without corrosive gas.
8.4 Validity period
Under normal storage conditions, the validity period of sterilized suture shall not be less than 3 years, and not more than 5 years.

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