1 Scope
This standard specifies the classification, requirements, test methods, inspection rules, and marking, packaging, transportation and storage of scalpel blades.
This standard is applicable to scalpel blades (hereinafter referred to as blades) which are installed on the handle of a scalpel for cutting soft tissue.
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 (excluding corrections) to, or revisions of, any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. For undated references, the latest edition applies.
GB/T 191 Packaging - Pictorial marking for handling of goods (GB/T 191-2000, eqv ISO 780:1997)
GB/T 1298 Carbon tool steels - Technical requirements (GB/T 1298-1986, neq ASTM A686:1979)
GB/T 1299 Alloy tool steels (GB/T 1299-2000, neq ASTM 681:1994)
GB/T 2828.1 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (GB/T 2828.1-2003, ISO 2859.1:1999, IDT)
GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1: Test method (GB/T 4340.1-1999, eqv ISO 6507.1:1997)
GB 8662 Fitting dimension between scalpel blades and handles (GB 8662-1988, ISO 7740:1985, IDT)
YY 0167 Nonabsorbable surgical suture
YY/T 1052 Marking requirements for surgical instrument
YY/T 0466 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied (YY/T 0466-2003, ISO 15223:2000, IDT)
Pharmacopoeia of the People's Republic of China (Edition 2000)
3 Classification and designation
3.1 Classification
Foreword II
1 Scope
2 Normative references
3 Classification and designation
4 Requirements
5 Test methods
6 Inspection rules
7 Marking
8 Packaging, transportation, storage and service life
Annex A (Normative) Sharpness test method for cutting edge of scalpel blade
Annex B (Normative) Elasticity test method
Annex C (Informative) Types and specifications of blades.
