YY 1116-2020 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 absorbable surgical sutures.
This standard is applicable to absorbable surgical sutures (hereinafter referred to as sutures) for suturing and ligating human tissues.
This standard is not applicable to specially designed 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 6682-2008 Water for analytical laboratory use - Specification and test methods
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
Pharmacopoeia of the People's Republic of China (Edition 2015, Volume IV)
3 Classification of sutures
3.1 Sutures are available with or without needles and are both supplied in sterile form.
3.2 Sutures are divided into 2 categories, A and B, by manufacturing material, standard, dyeing, structure and coating treatment (see Table 1):
——Category A suture, made from collagen of healthy mammals, is available in flat (not treated with chromium salts) and chrome (treated with chromium salts).
——Category B suture, made from synthetic polymer material, monofilament uncoated/coated, or multifilament coated.
Table 1 Classification of sutures
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 (Informative) Test method for moisture content
Annex D (Normative) Test method for discoloration
Bibliography
