YY/T 0245-2008 Translated English of Chinese Standard. (YYT 0245-2008, YY/T0245-2008, YYT0245-2008): General specifications for staplerhttps://www.chinesestandard.net, 2019 M11 2 - 19 pages This Standard specifies classification and type, requirements, test methods, inspection rules, marks, instruction manual, packaging, transport and storage for stapler. This Standard is applicable to reusable stapler and disposable stapler. This product is used for the stapler whose components are mounted on the stapler as round tubular incision as well as circular resection and anastomosis of the upper mucosa or stump incision closed suture. |
Contents
| 3 | |
Scope | 4 |
Classification and type | 5 |
Test methods | 7 |
Inspection rules | 9 |
Marks instruction manual | 11 |
Packaging transport storage | 14 |
Annex A normative Test method for suture pressure | 16 |
Annex B normative Test method for peel strength | 18 |
Common terms and phrases
address and trademark applicable to reusable Aseptic packaging Batch inspection Biological evaluation Class B Class code or trademark components and disposable composition of tantalum Corrosion resistance performance cytotoxicity Dialysis paper disposable body disposable stapler ethylene oxide residue evaluation of medical following marks inspection certificate Inspection item inspector code instruction manual intestinal lumen large packaging manufacturer’s code manufacturer’s name medical devices method specified once-sampling scheme packaging box packaging of stapler packaging patterns packaging seal peel strength Perform according periodic inspection Pharmacopoeia piece of stapler Pressure-endurance product registration number product standard product’s name production date last provisions of Table reference to product Rejection classification Class reusable stapler seal of disposable small packaging specified in GB/T stapled stapler after packaged stapler and disposable stapler body stapler nail stapler or component stapler shall comply sterilization method stump incision Surface roughness Surgical Instrument suture tantalum wire Test group titanium YY/T zip code