This standard specifies the classification, requirements, test methods, type inspection, labels and manual, packaging, transportation, storage and useful life of non-absorbable surgical sutures.
This standard is applicable to non-absorbable surgical sutures (hereinafter referred to as sutures) for suturing and ligating human tissues.
This standard is not applicable to specially designed non-absorbable surgical sutures.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
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 equipments for medical use - Part 1: Chemical analysis methods
GB/T 16886 (All parts) 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
Pharmacopoeia of the People's Republic of China (Edition 2015, Volume IV)
3 Classification of sutures
3.1 Form
Sutures are available with or without needles and are both supplied in sterile form.
3.2 Structure
The sutures may be classified into monofilament and multifilament (twisted and braided) ones by structure.
3.3 Materials
The manufacturing materials of sutures involve natural fibers, synthetic fibers and metal materials (in accordance with YY/T 0816-2010, Clause 3).
Note: Natural fibers include silk.
Synthetic fibers include polyethylene terephthalate, polyvinylene difluoride, polyamide 6, polyamide 6/6 and polypropylene.
Metallic materials include stainless steel wires.
3.4 Categories
Sutures are divided into 3 categories by manufacturing material, structure, dyeing and coating influence (see Table 1), of which:
Category A sutures are made of silk or synthetic fibers, with coatings not affecting the suture diameters;
Category B sutures are made of natural or synthetic fibers, with coatings affecting the suture diameters;
Category C sutures are made of metal.
Table 1 Classification of sutures
Category Category A Category B Category C
Material Natural fiber (silk)
Synthetic fiber Natural fiber (silk)
Synthetic fiber Metal
Dyeing Dyed or not dyed Dyed or not dyed —
Structure Multifilament Monofilament Monofilament or multifilament —
Coating Coated Uncoated/coated Made of natural fibers (silk) or synthetic fibers, with coatings affecting the suture diameters —
4 Requirements
4.1 Appearance
4.1.1 The sutures shall be smooth, evenly striped, stain-free and knot-free. The surface of any multifilament suture shall be coated.
Foreword I 1 Scope 2 Normative references 3 Classification of sutures 4 Requirements 5 Test methods 6 Type inspection 7 Labels and manual 8 Packaging, transportation, storage and useful life Annex A (Normative) Test method for measuring suture diameter Annex B (Normative) Test methods for breaking strength and needle-suture attachment strength Annex C (Normative) Test method for discolouration Bibliography
YY 0167-2020 Non-absorbable surgical suture
1 Scope
This standard specifies the classification, requirements, test methods, type inspection, labels and manual, packaging, transportation, storage and useful life of non-absorbable surgical sutures.
This standard is applicable to non-absorbable surgical sutures (hereinafter referred to as sutures) for suturing and ligating human tissues.
This standard is not applicable to specially designed non-absorbable surgical sutures.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
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 equipments for medical use - Part 1: Chemical analysis methods
GB/T 16886 (All parts) 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
Pharmacopoeia of the People's Republic of China (Edition 2015, Volume IV)
3 Classification of sutures
3.1 Form
Sutures are available with or without needles and are both supplied in sterile form.
3.2 Structure
The sutures may be classified into monofilament and multifilament (twisted and braided) ones by structure.
3.3 Materials
The manufacturing materials of sutures involve natural fibers, synthetic fibers and metal materials (in accordance with YY/T 0816-2010, Clause 3).
Note: Natural fibers include silk.
Synthetic fibers include polyethylene terephthalate, polyvinylene difluoride, polyamide 6, polyamide 6/6 and polypropylene.
Metallic materials include stainless steel wires.
3.4 Categories
Sutures are divided into 3 categories by manufacturing material, structure, dyeing and coating influence (see Table 1), of which:
Category A sutures are made of silk or synthetic fibers, with coatings not affecting the suture diameters;
Category B sutures are made of natural or synthetic fibers, with coatings affecting the suture diameters;
Category C sutures are made of metal.
Table 1 Classification of sutures
Category Category A Category B Category C
Material Natural fiber (silk)
Synthetic fiber Natural fiber (silk)
Synthetic fiber Metal
Dyeing Dyed or not dyed Dyed or not dyed —
Structure Multifilament Monofilament Monofilament or multifilament —
Coating Coated Uncoated/coated Made of natural fibers (silk) or synthetic fibers, with coatings affecting the suture diameters —
4 Requirements
4.1 Appearance
4.1.1 The sutures shall be smooth, evenly striped, stain-free and knot-free. The surface of any multifilament suture shall be coated.
Contents of YY 0167-2020
Foreword I
1 Scope
2 Normative references
3 Classification of sutures
4 Requirements
5 Test methods
6 Type inspection
7 Labels and manual
8 Packaging, transportation, storage and useful life
Annex A (Normative) Test method for measuring suture diameter
Annex B (Normative) Test methods for breaking strength and needle-suture attachment strength
Annex C (Normative) Test method for discolouration
Bibliography
