YY 1116-2020 English PDF

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YY 1116-2020: Absorbable surgical suture
Status: Valid

YY 1116: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 1116-2020	299	Add to Cart	3 days	Absorbable surgical suture	Valid
YY 1116-2010	759	Add to Cart	4 days	Absorbable surgical suture	Obsolete
YY 1116-2002	479	Add to Cart	4 days	Absorbable surgical suture	Obsolete

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Basic data

Standard ID: YY 1116-2020 (YY1116-2020)
Description (Translated English): 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: 16,150
Date of Issue: 2020
Date of Implementation: 2021-03-01
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the classification, requirements, test methods, type inspection, labeling, instructions, packaging, transportation, storage and expiration date of absorbable surgical sutures. This standard applies to absorbable surgical sutures for suture and ligation of human tissue. This standard does not apply to specially designed absorbable surgical sutures.

YY 1116-2020: Absorbable surgical suture

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Absorbable surgical suture ICS 11.040.30C31 People's Republic of China Pharmaceutical Industry Standards 2020-02-26 released Implementation of 2021-03-01 Issued by the National Medical Products Administration

Foreword

The 4.6.3 water content of this standard is a recommended clause, and other technical content is a mandatory clause. This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 1116-2010 "Absorbable Surgical Sutures". Except for editorial changes, the main technical changes are as follows. ---The non-applicable scope of the standard has been increased (see Chapter 1); ---Modified the suture classification (see Chapter 3, Chapter 3 of the.2010 edition); ---Modified the requirements of appearance (see 4.1.1, 4.1.1 of.2010 edition); ---Added the expression of the single value of the converted wire diameter (see Table 2,.2010 version 5.2.3); ---Modified the names of breaking strength and connection strength (see 4.3 and 4.4, the.2010 edition of 4.3 and 4.4.1); ---Deleted the needle requirement (see 4.4.2 of the.2010 edition); ---Modified the requirement of suture length (see 4.5, 4.5 in.2010 edition); ---The water content requirements have been revised (see 4.6.3, 4.6.3 of the.2010 edition); ---The labeling requirements for dyed sutures have been added (see 4.6.4); --- Modified the description of biological evaluation (see 4.8 and 5.8,.2010 edition of 4.7 and 5.7); ---Modified the wire diameter test method (see 5.2 Appendix A,.2010 Edition 5.2 and Appendix B); ---Modified the test methods of breaking strength and stitching strength (see Appendix B of 5.3 and 5.4, and 5.3 and 5.4.1 of.2010 edition); ---Modified the soluble compound test method (see 5.6.1.1,.2010 edition of 5.6.1.1); ---Revised the heavy metal test method (see 5.6.2.1, 5.6.2.1 of the.2010 edition); ---Modified the water content test method (see appendix C of 5.6.3, 5.6.3 and appendix C of.2010 edition); ---Modified the fading test method (see Appendix D of 5.6.4, 5.6.4 of.2010 edition); ---Modified the type inspection (see Chapter 6, Chapter 6 of the.2010 edition); ---Revised the label and instructions (see Chapter 7, Chapter 7 of the.2010 edition); ---Modified the suture storage and transportation conditions and validity period (see 8.5,.2010 version of 8.2 and 8.3). Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible 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). Drafting organizations of this standard. Shanghai Pudong Jinhuan Medical Products Co., Ltd., Shanghai Medical Device Testing Institute, Huaiyin Medical Devices Co., Ltd. Co., Ltd., Jiangsu Medical Device Inspection Institute. The main drafters of this standard. Zhang Yanqing, Huang Shuze, Lu Guangheng, Shi Zhigang, Wang Fengcai, Yao Yao, Gao Bai, Shi Yang, Zhang Naiming, Hu Yuwen. The previous editions of the standard replaced by this standard are as follows.

1 Scope

This standard specifies the classification, requirements, test methods, type inspection, labels, instructions, packaging, transportation, and storage of absorbable surgical sutures. And expiry date. This standard applies to absorbable surgical sutures (hereinafter referred to as sutures) for suturing and ligating human tissues. This standard does not apply to specially designed absorbable surgical sutures.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 191 Graphical signs for packaging, storage and transportation GB/T 6682-2008 Analytical laboratory water specifications and test methods GB/T 9737-2008 General Rules for the Determination of Easily Carbonized Substances in Chemical Reagents GB/T 9969 General Rules for Use of Industrial Products GB/T 14233.1-2008 Medical transfusion, blood transfusion, injection equipment inspection methods Part 1.Chemical analysis methods GB/T 16886 (all parts) Biological evaluation of medical devices YY/T 04666.1 Medical devices used for medical device labeling, marking and information symbols. Part 1.General requirements Pharmacopoeia of the People's Republic of China (2015 Edition·Fourth Edition)

3 Classification of sutures

3.1 There are two forms of sutures with and without suture needles, both of which are provided in a sterile form. 3.2 Sutures are divided into two categories. Class A and Class B according to manufacturing material, standard, dyeing, structure and coating treatment (see Table 1). ---Class A sutures are made of healthy mammalian collagen. They are available in flat (untreated with chromium salt) and chrome (treated with chromium salt). ---B type suture, made of synthetic polymer material, single strand without or with coating, multiple strands with coating.

4 requirements

4.1 Appearance 4.1.1 The surface of the suture should be smooth, uniform in color, evenly even, no stains, no knots. The surface of multi-strand sutures should be coated. 4.1.2 If the suture has needles, the needle and thread connection should be smooth and free of burrs. 4.2 Wire diameter 4.2.1 The single value of all sutures should be within the range of the single value of the wire diameter of the corresponding specifications specified in Table 2. 4.2.2 The average value of each suture should be within the range of the average value of the wire diameter of the corresponding specifications specified in Table 2. 4.3 Breaking strength The average and single value of the suture breaking strength should... ......

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