This standard specifies structure and marks, requirements, test methods, inspection rules, marking, packaging, transportation and storage and service life of the disposable scalpel.
This standard is applicable to the disposable scalpel (hereinafter referred to as scalpel) with sterilizing packaging, this product is used for surgery or used to cut soft tissue when dissecting.
2 Normative References
The following normative documents contain provisions which, through reference in this standard, constitute provisions of this standard. For dated references, subsequent amendments to (excluding corrections to), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this standard are encouraged to study whether the latest editions of these documents are applicable. For undated references, the latest edition of the normative documents referred to applies.
GB/T 1220-2007 "Stainless Steel Bars"
GB/T 1298-1986 "Carbon Tool Steels-Technical Requirements"
GB/T 1299-2000 "Alloy Tool Steels"
GB/T 2828.1-2003 "Sampling Procedures for Inspection by Attributea-Part1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-lot Inspection (ISO 2859-1:1999; IDT)"
GB/T 16886.7-2001 "Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals (idt ISO 10993-7: 1995)"
YY/T 0171-2008 "Surgical instruments-Packaging, Marking and Instructions"
YY 0174-2005 "Surgical Knife Blade"
YY/T 0466-2003 "Medical Devices - Symbols to be Used with Medical Device Labels, Marking and Information to be Supplied (ISO 15223: 2000, IDT)"
Pharmacopoeia of People's Republic of China - Part II
