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YY 0167-2020

Chinese Standard: 'YY 0167-2020'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY 0167-2020English259 Add to Cart Days<=3 Non-absorbable surgical suture Valid YY 0167-2020
YY 0167-2020Chinese17 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YY0167-2020 (YY0167-2020)
Description (Translated English) Non-absorbable surgical suture
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C31
Classification of International Standard 11.040.30
Word Count Estimation 13,115
Date of Issue 2020-02-26
Date of Implementation 2021-03-01
Older Standard (superseded by this standard) YY 0167-2005
Drafting Organization Johnson & Johnson (China) Medical Devices Co., Ltd., Shanghai Medical Device Testing Institute, Shanghai Pudong Jinhuan Medical Supplies Co., Ltd. and Huaiyin Medical Devices Co., Ltd.
Administrative Organization National Technical Committee for Standardization of Surgical Instruments (SAC / TC 94)
Regulation (derived from) Announcement No. 21 of 2020 by the State Administration of Drug Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY 0167-2020
Non-absorbable surgical suture
ICS 11.040.30
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0167-2005
Non-absorbable surgical suture
Released on 2020-02-26
2021-03-01 implementation
Issued by the State Drug Administration
Foreword
All technical contents of this standard are mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0167-2005 "Non-absorbable Surgical Suture", except for editorial changes, the main technical changes are as follows.
--- Increase the scope of the standard is not applicable (see Chapter 1);
--- Revised the classification of sutures (see Chapter 3, Chapter 3 of the.2005 edition);
--- Increased the expression of the single value of the wire diameter (see Table 2,.2005 version of Table 2);
--- Revised the names of breaking strength and connection strength (see 4.3 and 4.4,.2005 edition of 4.3 and 4.4);
--- Added the expression of single value of suture breaking strength (see Table 3, Table 3 of.2005 edition);
--- Revised the fading requirements (see 4.5, 4.5 in.2005);
--- Revised the length requirements (see 4.6,.2005 version 4.6);
--- Removed the requirements for sewing needles (see.2005 version 4.7);
--- Revised the description of biological evaluation (see 4.9 and 5.9,.2005 version 4.10 and 5.10);
--- Add the requirements and test methods for the marking of type B sutures (see 4.10 and 5.10);
--- Revised the wire diameter test method (see Appendix A of 5.2, 5.2 of.2005 edition);
--- Revised the test methods for breaking strength and needle thread connection strength (see Appendix B of 5.3 and 5.4, 5.3 and 5.4 of.2005 edition);
--- Revised type inspection (see Chapter 6, Chapter 6 of the.2005 edition);
--- Revised the requirements for labels and instructions (see Chapter 7, Chapter 7 of the.2005 edition);
--- Revised the storage and transportation conditions and validity period of sutures (see 8.5, 8.4 in.2005 version).
This standard refers to the US Pharmacopoeia (version 38) and the European Pharmacopoeia (version 8.0).
Please note that some content of this document may involve patents. The issuer of this document does not assume responsibility for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Surgical Instruments (SAC/TC94).
This standard was drafted by. Johnson & Johnson (China) Medical Equipment Co., Ltd., Shanghai Medical Device Testing Institute, Shanghai Pudong Jinhuan Medical Supplies
Co., Ltd. and Huaiyin Medical Devices Co., Ltd.
The main drafters of this standard. Ma Wenzhong, Huang Shuze, Zhang Yanqing, Lu Guangheng, Xia Aihong, Wang Fengcai.
The previous versions of the standard replaced by this standard are as follows.
--- YY 0167-1989;
--- YY 0167-1994;
--- YY 0167-1998;
--- YY 0167-2005.
Non-absorbable surgical suture
1 Scope
This standard specifies the classification, requirements, test methods, type inspection, labels, instructions, packaging, transportation, and storage of non-absorbable surgical sutures
And validity period.
This standard applies to non-absorbable surgical sutures for suture and ligation of human tissues (hereinafter referred to as sutures).
This standard does not apply to specially designed non-absorbable surgical sutures.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
GB/T 191 Graphic mark for packaging, storage and transportation
GB/T 8170 Numerical Rounding Rules and Representation and Judgment of Limit Values
GB/T 9737-2008 General rules for the determination of easily carbonized substances in chemical reagents
GB/T 9969 General Instructions for Use of Industrial Products
GB/T 14233.1-2008 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1. Chemical analysis methods
GB/T 16886 (all parts) Biological evaluation of medical devices
YY/T 0466.1 Medical devices Symbols used for labeling, marking and providing information of medical devices Part 1. General requirements
YY/T 0816-2010 Surgical implant sutures and other flexible metal wires for surgery
Four parts of the Pharmacopoeia of the People's Republic of China (2015 edition)
3 Classification of sutures
3.1 Form
The suture is available in two forms, with and without stitches, both of which are provided in a sterile form.
3.2 Structure
The structure of the suture is divided into single strands and multiple strands (twisted strands and braided).
3.3 Materials
The suture manufacturing materials involve natural fibers, synthetic fibers and metallic materials (in accordance with Chapter 3 of YY/T 0816-2010)
Note. Natural fibers, such as silk.
Synthetic fibers, such as polyethylene terephthalate, polyvinylidene difluoride, polyamide 6, polyamide 6/6 and polypropylene.
Metal materials, such as stainless steel wire.
3.4 Category
Sutures are divided into 3 categories according to manufacturing materials, structure, dyeing and coating effects (see Table 1), among which.
Class A suture, made of silk or synthetic fiber, the coating does not affect the thread diameter;
Related standard:   YY 0174-2019  YY 0450.1-2020
Related PDF sample:   YY 0167-2005  YY/T 0586-2016
   
 
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