YY/T 0752-2016Electrical surgical equipment for osseous tissue (English PDF)

1 Scope

This Standard specifies terms and definitions, product classification, technical requirements, test methods for electrical surgical equipment for osseous tissue.

This Standard is applicable to electrical surgical equipment for osseous tissue powered by network power supply (hereinafter referred to as the equipment).

This Standard is inapplicable to electrical surgical equipment for osseous tissue powered by internal power supply. This Standard is inapplicable to similar equipment for dentistry.

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 9706.1-2007, Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988, IDT)

GB/T 14710-2009, Environmental requirement and test methods for medical electrical equipment

YY/T 0149-2006, Medical instruments of stainless steel - Test methods of corrosion resistance (ISO 13402:1995, MOD)

YY 0505-2012, Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standards: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2004, IDT)

YY 1057-2016, General specifications for medical foot switch

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

4 Product classification

The classification according to the connection mode of the main frame and the handpiece is as follows:

a) Clamp the test rod or cutter to the handpiece. Then fix the handpiece on the measurement platform. Test with 30N of axial tension acting on the test rod or cutter. The test rod or cutter shall not fall off;

b) Clamp the test rod or cutter with the largest specification to the handpiece.

Then fix the handpiece on the measurement platform. Gradually load the test rod or cutter to 1.5 times the rated load. There shall be no relative slippage or permanent deformation between the test rod or cutter and the chuck.

a) When the set rotation speed is <=3000r/min, the equipment runs at low speed and no load. After the speed is stable, use a dial indicator to measure. Record the radial runout of the test rod or tool 20mm from the output end of the handpiece. Measure 3 times. The arithmetic average value shall meet the requirements of 5.2.3.

b) When the set rotation speed is >3000r/min, run at no-load within the recommended speed range. After the speed is stable, use a non-contact measuring instrument to measure. Record the radial runout of the test rod or cutter 20mm away from the output end of the handpiece. Measure 3 times. The arithmetic average value shall meet the requirements of 5.2.3.

Use a dial indicator to measure the relative displacement between the test rod or cutter and the handpiece chuck, which shall meet the requirements of 5.2.4.

After 3min, measure the highest temperature that can touch the surface of the handpiece shell. The test is carried out at an ambient temperature of 20°C ± 2°C.

Conduct visual inspection with a magnifying glass or hand feel inspection, without sharp edges, burrs, sharp corners.

6 Test methods

6.2.2 Perform the loading and unloading test of the test rod or cutter and the handpiece according to the instructions, which shall meet the requirements of 5.2.2.

6.2.3 Clamp the test rod or cutter to the handpiece. Then fix the handpiece on the test platform. Keep the test rod or cutter parallel to the test platform.

6.2.4 Install a test rod or cutter on the handpiece output. Fix the handpiece on the test platform. Apply an axial push-pull force of 10N on the test rod or cutter.

6.2.5 According to the manufacturer's instructions, load the largest specification test rod or cutter at the maximum speed and run the handpiece with no load.

6.2.6 Use ample block comparison method or electrical measurement method for surface roughness. The electrical measurement method shall be used for measurement during arbitration and shall meet the requirements of 5.2.6.