YY/T 0061-2021Specified electromagnetic wave therapy equipment (English PDF)

Foreword

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

This standard replaces YY/T 0061-2007 "Specific Electromagnetic Wave Therapy Device", compared with YY/T 0061-2007, except for editorial changes The main changes are as follows.

---Modified the definition of thermal response time, and changed the thermal response time to heating time (see 3.2, 3.3 in.2007 edition);

---Deleted the definition of specific electromagnetic wave therapy device (2007 edition 3.2);

--- Increased the structure and composition of the radiator (see 4.3);

---Relevant requirements for temperature unevenness have been revised (see 5.3.2, 5.3.2 of the.2007 edition);

---Modified the maximum allowable temperature limit (see 5.3.3, 5.3.3 of the.2007 edition);

---Relevant requirements for heating time (original thermal response time) have been modified (see 5.4.1, 5.4.1 of the.2007 edition);

---Relevant requirements and test methods for overheating protection have been modified (see 5.5, 6.5, 5.5 and 6.5 in.2007 edition);

---Increased flame resistance requirements (see 5.7);

--- Increased dielectric strength requirements at operating temperature (see 5.11);

--- Deleted the heater's working life requirement (2007 version 5.6);

---Delete the parts that overlap with the requirements of YY 0306 (5.8, 5.9, 5.10.3 of the.2007 edition).

1 Scope

This standard specifies the structure and composition, requirements and test methods of a specific electromagnetic wave therapy device (hereinafter referred to as the therapy device).

This standard is applicable to conform to the elements contained in the radiator that are excited by heat at a certain temperature, and the energy produced is mainly distributed in 2µm~ A therapeutic device for electromagnetic waves in the 25µm wavelength range.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 5169.16 Fire hazard test for electric and electronic products Part 16: Test flame 50W horizontal and vertical flame test method

GB/T 7287-2008 Infrared radiant heater test method

GB 9706.1 Medical electrical equipment Part 1: General requirements for basic safety and basic performance

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

GB 18871 Basic standard for ionizing radiation protection and radiation source safety

YY 0306 Special requirements for the safety of thermal radiation therapy equipment

YY 0505 Medical Electrical Equipment Part 1-2.General Safety Requirements Collateral Standard

3 Terms and definitions

4 Structure and composition

4.1 Treatment head. It should include heating elements, radiators and protective covers.

4.2 Heating element. a conductive heating material that converts electrical energy into heat energy to provide heat for the radiator.

4.3 Radiator. It has a specific element composition or coating, and is expected to absorb heat and radiate electromagnetic waves to the patient. Parts in direct contact with the body.