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YY 0167-2020 English PDF (YY0167-2020)

YY 0167-2020 English PDF (YY0167-2020)

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YY 0167-2020: Non-absorbable surgical suture

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 for suturing and ligating human tissues. This Standard does not apply to specially designed non-absorbable surgical suture.
YY 0167-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.30
C 31
YY/T 0167-2020
Replacing YY 0167-2005
Non-absorbable surgical suture
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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 ??g/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.

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