YY/T 0178-2010 Rectosigmoid biopsy forceps
1 Scope
This standard specifies the types & materials, requirements, test methods, inspection rules, marking, packaging, transportation and storage of rectosigmoid biopsy forceps.
This standard is applicable to rectosigmoid biopsy forceps (hereinafter referred to as forceps) used to take living tissues of rectum and sigmoid colon for examination.
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 of the referenced document (including any amendments) applies.
GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1: Test method (GB/T 4340.1-2009, ISO 6507-1:2005, MOD)
GB/T 1220 Stainless steel bars
GB 1911 Copying paper
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 2829 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability)
GB/T 10610 Geometrical product specifications (GPS) - Surface texture: Profile method - Rules and procedures for the assessment of surface texture (GB/T 10610-2009, ISO 4288:1996, IDT)
YY/T 0149 Medical instruments of stainless steel - Test methods of corrosion resistance (YY/T 0149-2006, ISO 13402:1995, MOD)
YY/T 1052 Marking requirements for surgical instruments
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 0466.1-2009, ISO 15223-1:2007, IDT)
3 Types and materials
3.1 The types and basic dimensions of forceps shall meet the requirements of Figure 1 and Table 1.
3.2 The jaws and body of a pair of forceps may be made of 20Cr13, 30Cr13, 32Cr13Mo as specified in GB/T 1220 or other applicable materials meeting the requirements of Clause 4 herein.
Foreword I
1 Scope
2 Normative references
3 Types and materials
4 Requirements
5 Test methods
6 Inspection rules
7 Marking
8 Packaging, transportation and storage