This standard specifies the classification and identification, requirements, test methods, type inspection, label and instruction, packaging, transportation and storage and validity period of scalpel blade.
This standard is applicable to surgical blades installed on the scalpel handle for cutting soft tissues (hereinafter referred to as blades).
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB/T 191 Packaging—Pictorial marking for handling of goods
GB/T 1299 Tool and mould steels
GB/T 4340.1 Metallic materials—Vickers hardness—Part 1: Test method
GB 8662 Fitting dimension between scalpel blades and handles
GB/T 9969 General principles for preparation of instructions for use of industrial products
GB/T 14233.1 Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
YY 0167-2005 Non-absorbable surgical suture
YY/T 0294.1 Surgical instrumentsDMetallic materialsDPart 1:Stainless steel
YY/T 0466.1 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirements
YY/T 1052 Marking requirements for surgical instruments
Pharmacopoeia of the People's Republic of China (Edition 2015, Volume IV)
3 Classification and identification
3.1 Delivery status
Blades are delivered in either sterile or non-sterile states (hereinafter referred to as sterile blades and non-sterile blades).
