YY 0167-2005: Translated English of Chinese Standard. YY0167-2005: Non-absorbable surgical suture
https://www.chinesestandard.net, 2014 M08 26 - 16 pages
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 used in human tissue suture and ligation in medical operation.
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Signs and instructions
Packaging transportation and storage
batch number batch-by-batch inspection Biological evaluation Category Ⅰ Category Category Ⅱ Category Category Ⅲ conducted according conventional specification Cytotoxicity date or batch diameter measuring instrument Ethylene oxide residue evaluation of medical extract of test fixtures following signs GB/T Genotoxicity Ⅰ Category Ⅱ idt ISO Ⅱ Category inspection item inspection rules intermediate value ional Category Ⅰ items and sampling manufacturer material testing machine medical device needle and suture Non-absorbable surgical suture number of medical packaged by liquid periodic inspection Pharmacopoeia polyamide Preparation of water presser foot Product registration certificate production batches Production date Pyrogen quantity of product registration certificate number requirements of Chapter sign of disposable specifications and quantity Specifications and wire specifications of suture standard colorimetric solution Sterilization methods strength of needle suture shall comply suture Specifications synthetic fiber Test equipment test material test methods test Preparation test solution Validity period water extract wire diameter measuring wire diameter range