This standard specifies the classification, materials, requirements, test methods, inspection rules, marking, packaging, transportation and storage of medical forceps.
This standard is applicable to reusable medical forceps for clamping human tissues or dressings, including the following categories:
——Tissue forceps: clamp human tissues;
——Thoracic forceps: clamp thoracic tissues;
——Myocardial forceps: clamp myocardial tissues;
——Brain forceps: clamp brain tissues;
——Nasal forceps: clamp and separate nasal tissues;
This standard is not applicable to active medical forceps or those made of non-metallic materials.
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 1220-2007 Stainless steel bars
GB/T 1800.1-2009 Geometrical product specifications (GPS) - Limits and fits - Part 1: Bases of tolerances, deviations and fits
GB/T 3280-2007 Cold rolled stainless steel plate, sheet and strip
GB/T 3621-2007 Titanium and titanium alloy plate and sheet
GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1: Test method
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance
YY/T 1052-2004 Marking requirements for surgical instruments
3 Classification
Medical forceps can be divided into straight and curved (including curved, knee-shaped and gun-shaped) ones by type, which shall meet the requirements of Figure 1 and Figure 2.
The dimensions of medical forceps (including at least length L, head breadth b and head thickness δ) shall be specified by the manufacturer, and the nominal dimensions shall be marked in the specifications and models.
Foreword I 1 Scope 2 Normative references 3 Classification 4 Materials 5 Requirements 6 Test methods 7 Periodic inspection 8 Marking 9 Instructions for use 10 Packaging, transportation and storage Annex A (Normative) Test method for deformation amount of medical forceps Annex B (Normative) Test method for kneading force Annex C (Normative) Test method for connection firmness
