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YY/T 0982-2016Heating and magnetic vibrator therapeutic equipment (English PDF)

热磁振子治疗设备

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 23, 2016

Implementation date

January 1, 2017

Scope

YY/T 0982-2016 is the English-translated version of 热磁振子治疗设备.

YY/T 0982-2016 is the Chinese pharmaceutical industry standard for thermomagnetic transducer therapy equipment, the device that treats by applying heat together with a magnetic field.

It gives the terms and definitions, the requirements and the test methods, covering the magnetic flux density produced and its distribution, the temperature reached at the applicator and its control, the timer, the materials in contact with the patient and the electrical safety. Issued on 23 March 2016, it has applied since 1 January 2017.

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Document preview — YY/T 0982-2016

National Standard of the People's Republic of China

ICS: 11.040.60
Classification: C 42

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative reference documents
3 Terms and definitions GB 9706.1-2007 and the following
4 Requirements

Foreword

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

1 Scope

This standard specifies the terms and definitions, requirements, and test methods for thermomagnetic transducer treatment equipment (hereinafter referred to as equipment).

This standard applies to the equipment defined in 3.1. This standard does not apply to thermal pad therapeutic apparatus.

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 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 A medical electrical device in which the application part comprises a thermomagnetic transducer, which utilizes the magnetic field generated by the thermomagnetic transducer, vibrates and conducts heat to the patient For treatment.

GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (ISO 10993-1.:2009, 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)

3 Terms and definitions GB 9706.1-2007 and the following

terms and definitions apply to this document.

3.2 Thermal magnetator

Components made of winding coils and ferromagnetic materials. When there is a pulse or alternating current through, the part will heat up and produce both magnetic Field and vibration.

3.3 Steady state temperature

After the equipment has been in operation for some time, the temperature of the application part starts to fluctuate within ± 0.5 ° C of a certain temperature value, which is steady-state temperature.

4 Requirements

4.1 Normal working conditions

Shall comply with the manufacturer's regulations; if not specified, it shall comply with the requirements of Chapter 10 of GB 9706.1-2007.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.

Referenced standards

Normative references

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