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YY 0167-2005

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YY 0167-2005 英文版 380 购买 现货,9秒内自动发货PDF,有增值税发票。 非吸收性外科缝线 作废

   
标准编号: YY 0167-2005 (YY0167-2005)
中文名称: 非吸收性外科缝线
英文名称: Non-absorbable surgical suture
行业: 医药行业标准
中标分类: C31
国际标准分类: 11.040.30
字数估计: 11,18
发布日期: 2005-07-18
实施日期: 2006-06-01
旧标准 (被替代): YY 0167-1998
引用标准: GB/T 9737-1988; GB/T 14233.1-1998; GB/T 14436; GB/T 16175-1996; GB/T 16886.1; GB/T 16886.3-1997; GB/T 16886.10-2005; YY 0466-2003; YY 0043; 中华人民共和国药典(2000年版)
起草单位: 强生(中国)医疗器材有限公司
归口单位: 全国外科器械标准化技术委员会
标准依据: 国食药监械(2005)380号
提出机构: 全国外科器械标准化技术委员会
发布机构: 国家食品药品监督管理局
范围: 本标准规定了非吸收性外科缝线的分类、要求、试验方法、检验规则、标志、使用说明书、包装、运输和贮存。本标准适用于在医疗手术中用于人体组织缝合、结扎的非吸收性外科缝线(以下简称缝线)。


YY 0167-2005
ICS 11.040.30
C 31
YY
Pharmaceutical Industry Standard
of the People’s Republic of China
Replacing YY 0167-1998
Non-absorbable surgical suture
非吸收性外科缝线
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 & 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.
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
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
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 Ⅰ 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.
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
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
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.
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
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;
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;
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
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
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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