YY 0167-2005 Translated English of Chinese Standard. YY0167-2005: Non-absorbable surgical suturehttps://www.chinesestandard.net, 26 ago 2014 - 16 pagine 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. |
Sommario
| 3 | |
Scope | 4 |
Classification | 5 |
Requirements | 6 |
Test methods | 8 |
Inspection rules | 12 |
Signs and instructions | 14 |
Packaging transportation and storage | 16 |
Parole e frasi comuni
Average value Single batch number batch-by-batch inspection Biological evaluation Category Ⅱ Category Category Ⅲ Cobalt chloride CoCl2 colorimetric solution According 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 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 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