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YY 0167-2005 English PDF (YY 0167-2020 Newer Version)

YY 0167-2005_English: PDF (YY0167-2005)
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY 0167-2020English235 Add to Cart 0--9 seconds. Auto-delivery Non-absorbable surgical suture Valid YY 0167-2020
YY 0167-2005English150 Add to Cart 0--9 seconds. Auto-delivery Non-absorbable surgical suture Obsolete YY 0167-2005
YY 0167-1998English399 Add to Cart 3 days [Need to translate] Nonabsorbable surgical suture Obsolete YY 0167-1998
YY 0167-1994EnglishRFQ ASK 3 days [Need to translate] (Medical thread) Obsolete YY 0167-1994
Preview PDF: YY 0167-2020    Standards related to: YY 0167-2005

BASIC DATA
Standard ID YY 0167-2005 (YY0167-2005)
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 11,125
Date of Issue 2005-07-18
Date of Implementation 2006-06-01
Older Standard (superseded by this standard) YY 0167-1998
Quoted Standard 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
Drafting Organization Johnson & Johnson (China) Medical Equipment Co., Ltd.
Administrative Organization National Standardization Technical Committee of Surgical Instruments
Regulation (derived from) SFDA (2005) 380
Proposing organization National Surgical Instruments Standardization Technical Committee
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the classification of non- absorbable surgical sutures, requirements, test methods, inspection rules, marking, manual, packaging, transportation and storage. This standard applies to medical procedures used in human tissue suture ligation of non-absorbable surgical suture (hereinafter referred to as sutures).


YY 0167-2020 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.30 C 31 YY/T 0167-2020 Replacing YY 0167-2005 Non-absorbable surgical suture 非吸收性外科缝线 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  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 YY/T 0466.1, Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements YY/T 0816-2010, Implants for surgery - Malleable wires for use as sutures and other surgical applications The length of the suture shall not be greater than 5.5 m, and not less than 95% of the marked length. 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. 4.9 Biological evaluation The suture is subjected to biological evaluation according to the GB/T 16886 series standards; there shall be no biocompatibility hazards. 4.10 Marking If it is a Class-B suture, it shall be clearly marked on the single package label. 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. 5.4 Needle and suture connection strength The test method is shown in Appendix B, which shall comply with 4.4. 5.5 Color fading The test method is shown in Appendix C, which shall comply with 4.5. 5.6 Length Straighten the suture without tension; place it steadily on a flat surface; use a universal measuring tool to measure; it shall meet the requirements of 4.6. e) Material, structure and length of the suture; f) Batch code or batch number, production date, operating life or expiration date; g) Description of Class-B suture (if applicable); h) Words or symbols of "please refer to the instruction for other contents" (if applicable). 7.1.2 Each minimum sales unit packaging shall have at least the following contents or symbols: a) Name and address of the registrant and/or the manufacturer; b) Product name and quantity; c) Models, specifications; d) Material, structure and length of the suture; e) Product registration certificate number, production license number (if applicable); f) Sterilization method or marking; g) Production date, batch number and operating life or expiration date; h) Description of Class-B suture (if applicable). 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: a) Name, address, contact information and after-sales service information of the registrant and/or the manufacturer; b) Production license number, product registration certificate number, and product technical requirement number of the suture; c) Product name, model, specifications, scope of application, performance, manufacturing material and structure of the suture; d) Storage, transportation conditions and methods; e) Description of single use, sterilization method, production date, operating life or expiration date; f) Explanation of graphics, symbols and abbreviations that are used on the label; g) Date of compilation or revision of the instruction; h) Contraindications, precautions, warnings and tips for the suture: 1) Requirements to ensure the correct and safe use of the suture, and post-processing requirements for safe use; 2) Precautions when using sutures in conjunction with other instruments; 3) The treatment method when the minimum single package is damaged shall be indicated. 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. 8.3 The minimum sales unit shall be accompanied by instructions, quality certification marks or product certificate. 8.4 Under the transportation conditions that are specified by the manufacturer, the packaging is undamaged; the writing on the packaging label shall be clear within the validity period. 8.5 The storage and transportation conditions and validity period of the suture shall be specified by the manufacturer. ......