YY/T 0454-2008 Translated English of Chinese Standard. (YYT0454-2008): Disposable scalpelThis standard specifies the structure and marking, requirements, test methods, inspection rules, signs, packaging, transportation, storage, use period of disposable scalpels. This standard applies to disposable scalpels, in sterile packaging for single use, which are used to cut soft tissue, during surgery or dissection. |
Contents
| 3 | |
Scope | 4 |
Structure and marking | 5 |
Test method | 6 |
Sign | 8 |
Appendix A Normative Test of connection firmness between blade and handle | 10 |
References | 11 |
Common terms and phrases
3.1 Product structure 8.4 Use period A.1 Device requirements acceptance quality limit according adjustment block amount of ethylene Appendix Batch-by-batch inspection blade and handle block and adjustment blocks fixed block comply Connection firmness Cutting edge cutting-edge protection date of sterilization disposable scalpels Disqualification category documents edition ensure ethylene oxide Figure inspection batch inspection is determined Inspection item Inspection level Inspection rules Judgment rules large package load material as specified Medical Devices meet the requirements Model marked Normative order contract Packaging sign People's Republic periodic inspection Pharmacopoeia plastic handle quality limit AQL references relevant provisions Republic of China requirements of Chapter Residual amount results shall meet sampling plan sampling quantity Scalpel blade small package specified in GB/T Stainless steel standard storage Structure and marking support blocks fixed support both ends surgical blade Surgical Instrument Table Technical test Carry Test method tool steels transportation upper plane YY/T