YY/T 0165-2016Medical heating pad therapy equipment (English PDF)

Foreword

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

This standard replaces YY/T 0165-2007 "hot pad treatment instrument", compared with YY/T 0165-2007 the main changes are as follows.

--- modified the scope of application;

--- redefine the definition of "steady state" and "working temperature" --- modified the accuracy of the temperature requirements;

--- increased the uniformity of temperature, stability requirements, and the corresponding test methods;

--- modified the over-temperature protection device requirements and test methods;

--- increased the requirements for the use of the instructions;

--- modified the temperature test device and the temperature test method.

1 Scope

This standard specifies the terms and definitions, requirements, test methods, inspection rules, marking, packaging, transportation and storage of thermal pad therapeutic apparatus.

This standard applies to the thermal pad type therapeutic apparatus (hereinafter referred to as the therapeutic apparatus) as defined in 3.1. This standard does not apply to the following equipment.

--- thermal magnetizer treatment equipment;

--- for equipment without self-care, there may be no control of the use of heating equipment (YY 0834-2011);

--- Medical temperature control blanket equipment.

2 Normative reference documents

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

GB/T 191-2008 Packaging and storage icon (ISO 780.:1997, MOD) A flexible part that can be bent, placed on the patient or body, for the application part of the heating.

GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT) Environmental requirements and test methods for medical appliances GB/T 14710-2009

YY/T 0466.1-2016 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General purpose (ISO 15223-1.:2010, IDT)

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

YY 0834-2011 Medical electrical equipment - Part 2. Particular requirements for the safety of medical electric blankets, electric heating mats and electric mattresses (IEC 60601-2-35.:1996)

3 Terms and definitions

The following terms and definitions apply to this document.