YY/T 0324-2019Infrared screening equipment for mammary gland (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces YY 0324-2008 "Infrared Breast Inspector", compared with YY 0324-2008, except for editorial modifications The changes are as follows.

--- Added the definition of infrared breast tester (see 3.1);

--- Increased composition (see 4.1);

--- Modified the classification (see Chapter 4.2 of the 2008 edition);

--- Modified the effective spectral wavelength range of the probe (see 5.2.2, 4.2.1 of the 2008 edition);

--- Increased UV radiation (see 5.2.3);

--- Increased probe surface temperature (see 5.2.4);

--- Increased protection of the eyes (see 5.2.5);

--- Increased the infrared response capability of the camera (see 5.3.2);

--- Increased material requirements (see 5.5);

--- Increased cleaning and disinfection requirements (see 5.6);

--- Increased electromagnetic compatibility requirements (see 5.9);

--- Increased the spectral weighting function for evaluating UV hazards (see Appendix A).

1 Scope

This standard specifies the terms and definitions, composition and classification, requirements and test methods of infrared breast testers.

This standard is applicable to the illumination of the breast tissue through the infrared light probe, and the captured image is displayed on the screen through the camera system.

An instrument for examining breast diseases (hereinafter referred to as an inspection instrument).

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB 7247.1-2012 Safety of laser products - Part 1. Equipment classification, requirements

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

GB 9706.15-2008 Medical electrical equipment - Part 1-1. Safety common requirements Parallel standard. Safety of medical electrical systems Seeking (IEC 60601-1-1:2000, IDT)

GB/T 14710-2009 Environmental requirements and test methods for medical appliances

GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (ISO 10993- 1.2009, IDT)

GB/T 20145-2006 Photobiosafety of lamps and lamp systems

YY 0505-2012 Medical Electrical Equipment - Part 1-2. Safety General Requirements Parallel Standard. Electromagnetic Compatibility Requirements and Test (IEC 60601-1-2:2004, IDT)

3 Terms and definitions

The following terms and definitions apply to this document.

4 Composition and classification