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YY 0167-2020 PDF English

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YY 0167-2020: Non-absorbable surgical suture
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Status: Valid

YY 0167: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
YY 0167-2020English235 Add to Cart 0-9 seconds. Auto-delivery Non-absorbable surgical suture Valid
YY 0167-2005English150 Add to Cart 0-9 seconds. Auto-delivery Non-absorbable surgical suture Obsolete
YY 0167-1998English399 Add to Cart 3 days Nonabsorbable surgical suture Obsolete
YY 0167-1994EnglishRFQ ASK 3 days (Medical thread) Obsolete

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YY 0167-2020: Non-absorbable surgical suture

---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/YY0167-2020
YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.30 C 31 YY/T 0167-2020 Replacing YY 0167-2005 Non-absorbable surgical suture Issued on. FEBRUARY 26, 2020 Implemented on. MARCH 01, 2021 Issued by. National Medical Products Administration

Table of Contents

Foreword... 3 1 Scope... 5 2 Normative references... 5 3 Classification of suture... 6 4 Requirements... 7 5 Test method... 10 6 Type inspection... 11 7 Labels, instructions... 11 8 Packaging, transportation, storage and validity period... 13 Appendix A (Normative) Suture diameter measurement test method... 14 Appendix B (Normative) Test methods for breaking strength and needle and suture connection strength... 16 Appendix C (Normative) Color fading test method... 18 References... 19

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; the main technical changes, except editorial changes, are as follows. -- Add the non-application scope of the standard (see Chapter 1); -- Modify the classification of sutures (see Chapter 3; Chapter 3 of version 2005); -- Add the expression of a single value of suture diameter (see Table 2, Table 2 of version 2005); -- Modify the names of breaking strength and connection strength (see 4.3 and 4.4; 4.3 and 4.4 of version 2005); -- Add the expression of the single value of the suture breaking strength (see Table 3; Table 3 of version 2005); -- Modify the color fading requirements (see 4.5; 4.5 of version 2005); -- Modify the length requirements (see 4.6; 4.6 of version 2005); -- Delete the requirements of suture needles (see 4.7 of version 2005); -- Modify the description of biological evaluation (see 4.9 and 5.9; 4.10 and 5.10 of version 2005); -- Add the requirements and test methods for the marking of Class-B sutures (see 4.10 and 5.10); -- Modify the suture diameter test method (see Appendix A of 5.2; 5.2 of version 2005); -- Modify the test methods for breaking strength and needle and suture connection strength (see Appendix B of 5.3 and 5.4; 5.3 and 5.4 of version 2005); -- Modify the type inspection (see Chapter 6; Chapter 6 of version 2005); -- Add requirements for labels and instructions (see Chapter 7; Chapter 7 of version 2005); -- Modify the suture storage and transportation conditions and validity period (see 8.5; 8.4 of version 2005). This Standard refers to U. S. Pharmacopoeia 38 and European Pharmacopoeia 8.0. Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This Standard was proposed by National Medical Products Administration. This Standard shall be under the jurisdiction of National Technical Committee 94 on Chirurgicum Apparatus of Standardization Administration of China (SAC/TC 94). The drafting organizations of this Standard. Johnson & Johnson Medical (China) Ltd., Shanghai Medical Device Testing Institute, Shanghai Pudong Jinhuan Medical Products Co., Ltd. and Huaiyin Medical Instruments Co., Ltd. The drafters of this Standard. Ma Wenzhong, Huang Shuze, Zhang Yanqing, Lu Guangheng, Xia Aihong, Wang Fengcai. The previous versions of the standards which are replaced by this Standard are. -- 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 inspections, labels, instructions, packaging, transportation, storage and validity period of non-absorbable surgical suture. This standard applies to non-absorbable surgical suture (hereinafter referred to as suture) for suturing and ligating human tissues. This Standard does not apply to specially designed non-absorbable surgical suture.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191, Packaging - Pictorial marking for handling of goods GB/T 8170, Rules of rounding off for numerical values & expression and judgment of limiting values GB/T 9737-2008, Chemical reagent - General rules for the determination of readily carbonizable substances GB/T 9969, General principles for preparation of instructions for use of industrial products GB/T 14233.1-2008, Test methods for infusion, transfusion, injection equipment for medical use - Part 1.Chemical analysis methods GB/T 16886, Biological evaluation of medical devices

3 Classification of suture

3.1 Form There are two forms of sutures, with suture needle and without suture needle, both of which are provided in sterile form. 3.4 Categories The suture is divided into 3 categories according to the manufacturing material, structure, dyeing and coating influence (see Table 1), of which.

4 Requirements

4.1 Appearance 4.2 Suture diameter 4.2.1 The single value of all sutures shall be within the range of the single value of the suture diameter of the corresponding specifications that are specified in Table 2. 4.3 Breaking force The average value and single value of the suture breaking force shall meet the requirements of Table 3. 4.4 Needle and suture connection strength If the suture has a needle, the average value and single value of the needle and suture connection strength shall meet the requirements of Table 4. 4.5 Color fading If the suture is dyed, the color of the corresponding standard color solution shall be clearly marked on the product technical requirements; the color of the extract shall not be darker than the standard color solution. 4.7 Sterility The suture is sterilized through a confirmed sterilization process and shall be sterile. 4.8 Residue of ethylene oxide If the suture is sterilized by ethylene oxide gas, the residue of ethylene oxide (excluding the suture needle) is not more than 250 μg/g.

5 Test method

5.1 Appearance Visually inspect under normal light, which shall meet the requirements of 4.1. 5.2 Suture diameter The test method is shown in Appendix A, which shall comply with 4.2. 5.3 Breaking force The test method is shown in Appendix B, which shall comply with 4.3. 5.7 Sterility Perform it in accordance with the provisions of "sterility test method" of the "Pharmacopoeia of the People’s Republic of China” (2015 Edition) Volume IV, which shall meet the provisions of 4.7. 5.8 Residue of ethylene oxide Perform the test according to Chapter 9 "Gas chromatography" of GB/T 14233.1-2008, which shall meet the requirements of 4.8.

6 Type inspection

The type inspection items and sample size of the suture are shown in Table 5. All inspection items shall be qualified.

7 Labels, instructions

7.1 Labels 7.1.1 Each single package shall have at least the following contents or symbols. 7.1.2 Each minimum sales unit packaging shall have at least the following contents or symbols. 7.1.3 The packaging, storage and transportation marks on the packaging shall comply with the relevant regulations of GB/T 191 and YY/T 0466.1. 7.2 Instructions There should be an instruction in each minimum sales unit; the preparation of the instruction shall comply with the provisions of GB/T 9969, and shall contain at least the following contents.

8 Packaging, transportation, storage and validity period

8.1 The single package shall be the minimum package available for use. Sterilized sutures remain sterile during the validity period. 8.2 After the single package is opened, there shall be traces of opening. 8.5 The storage and transportation conditions and validity period of the suture shall be specified by the manufacturer. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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