YY 0167-2020 English PDF (YY 0167-2005, YY 0167-1998)

YY 0167-2020_English: PDF (YY0167-2020)
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY 0167-2020235 Add to Cart Auto, < 3 mins Non-absorbable surgical suture Valid
YY 0167-2005150 Add to Cart Auto, < 3 mins Non-absorbable surgical suture Obsolete
YY 0167-1998399 Add to Cart 3 days Nonabsorbable surgical suture Obsolete
YY 0167-1994RFQ ASK 3 days (Medical thread) Obsolete

BASIC DATA
Standard ID YY 0167-2020 (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 13,133
Date of Issue 2020
Date of Implementation 2021-03-01
Summary This standard specifies the classification, requirements, test methods, type inspection, labeling, instructions, packaging, transportation, storage and expiration date of non-absorbable surgical sutures. This standard applies to non-absorbable surgical sutures for suture and ligation of human tissue. This standard does not apply to specially designed non-absorbable surgical sutures.

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Older Standard (superseded by this standard) YY 0167-1998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).

BASIC DATA
Standard ID YY 0167-1998 (YY0167-1998)
Description (Translated English) Nonabsorbable surgical suture
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C48
Word Count Estimation 10,118
Date of Issue 1998/8/27
Date of Implementation 1998/10/1
Older Standard (superseded by this standard) YY 0167-1994


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. ......


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. 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 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. 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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