YY 0167-2020 Translated English of Chinese Standard. YY0167-2020: Non-absorbable surgical suturehttps://www.chinesestandard.net, 12. 9. 2020 - Počet stran: 19 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. |
Obsah
All technical contents of this Standard are mandatory | 4 |
Foreword | 5 |
Normative Color fading test method | 18 |
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adjusted test gauge affects the suture and/or the manufacturer Average value/N Single breaking strength Calculate the average Class-B suture comply corresponding specifications diameter measuring instrument ethylene oxide European Pharmacopoeia FeCl3 following contents Gas chromatography Huaiyin instruction Johnson & Johnson least the following manufacturing material material testing machine Medical Device meet the requirements method is shown metric system minimum sales unit mm/min Natural fiber silk needle and suture non-absorbable surgical suture Pharmacopoeia polyamide polyethylene terephthalate presser foot load pressing plate product certificate Product name Production license number provisions of GB/T registrant and/or repeat steps A.2.1 Residue of ethylene shown in Appendix single-strand suture standard color solution stationary fixtures Sterilization method storage and transportation strand Single suture and repeat suture connection strength suture diameter measuring suture needle sutures whose specifications synthetic fiber Take another suture test gauge length test method Test procedure transportation conditions validity period value of suture value/N Single value/N