YY/T 0165-2016 English PDF

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YY/T 0165-2016: Medical heating pad therapy equipment
Status: Valid

YY/T 0165: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0165-2016	319	Add to Cart	3 days	Medical heating pad therapy equipment	Valid
YY/T 0165-2007	319	Add to Cart	3 days	Medical heating pad therapy equipment	Obsolete
YY 0165-1994	319	Add to Cart	3 days	(Hot splint therapy device)	Obsolete

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Basic data

Standard ID: YY/T 0165-2016 (YY/T0165-2016)
Description (Translated English): Medical heating pad therapy equipment
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C42
Classification of International Standard: 11.040.60
Word Count Estimation: 16,149
Date of Issue: 2016-07-29
Date of Implementation: 2017-06-01
Older Standard (superseded by this standard): YY/T 0165-2007
Regulation (derived from): State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies): State Food and Drug Administration

YY/T 0165-2016: Medical heating pad therapy equipment

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Medical heating pad equipment equipment ICS 11.040.60 C42 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 0165-2007 Heat pad treatment instrument 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued Directory Preface III 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 requirements 2 5 Test methods 3 6 inspection rules 6 7 logo, label, instruction manual 6 8 Packaging, transportation and storage 8 Appendix A (Informative Annex) Preparation of Special Terms 9 Appendix B (normative) Temperature test device Appendix C (Normative Appendix) Requirements for Thermal Insulation Materials 13

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. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Electrical Apparatus Standardization Technical Committee of Physiotherapy Equipment Subcommittee (SAC/TC10/SC4) centralized. The standard drafting unit. Tianjin Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Yang Guojuan, Duan Chuanying, Han desert, Wu Gang. The previous release of this standard is. YY/T 0165-1994, YY/T 0165-2007. Heat pad treatment instrument

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 article Pieces. 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) 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. 3.1 The device is treated in a heat conduction manner by the thermal effect of the thermal pad placed on the local body of the patient's body. 3.2 Hot pad medicalheatingpad A flexible part that can be bent, placed on the patient or body, for the application part of the heating. 3.3 Steady state temperature After the treatment instrument for a period of time, the temperature of the thermal pad reaches the steady state. 3.4 Steady state state The temperature of the center of the surface of the effective heating zone of the hot pad is within the maximum treatment time that can be set and the temperature fluctuates by no more than 2 ° C. ......

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