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YY/T 1496-2016Red light therapy equipment (English PDF)

红光治疗设备

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

July 29, 2016

Implementation date

June 1, 2017

Scope

YY/T 1496-2016 is the English-translated version of 红光治疗设备.

YY/T 1496-2016 is the Chinese pharmaceutical industry standard for red light therapy equipment, the device that treats with visible red light.

It specifies the terms and definitions, the composition, the requirements, the test methods, the inspection rules, the marking and the rules for packaging, transport and storage, covering the wavelength band and the irradiance delivered at the treatment distance and their accuracy, the uniformity over the treated area, the timer, the heat reaching the skin, the protection of the eyes and the electrical safety. Issued on 29 July 2016, it has applied since 1 June 2017.

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Document preview — YY/T 1496-2016

National Standard of the People's Republic of China

Classification: C 42

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

Preface
1 Scope
2 normative reference document
3 Terms and definitions
4 Composition
5 request
6 Test Method
7 Inspection Rules
8 logo, label, instruction manual
9 Packaging, transportation, storage
Appendix A (informative) Evaluation of the spectral weighting function of UV hazards

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, composition, requirements, test methods, inspection rules, marking, packaging, transportation and Storage.

This standard applies to the red light treatment equipment defined in 3.1 (hereinafter referred to as equipment). For a multi-functional device, this standard is in rule The contents of the device only apply to the device's red light treatment function, the device's other functions should meet the requirements of the relevant standards.

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 Medical electrical equipment - Part 1. General requirements for safety GB 9706.1-2007

GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety - Side standard. Medical electrical system safety Claim Environmental requirements and test methods for medical appliances GB/T 14710-2009

GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1. Generic Claim

YY 0505-2012 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests

3 Terms and definitions

GB 9706.1-2007 and the following terms and definitions apply to this document.

3.1 Red light therapy equipment

It is expected that irradiation of the patient's body surface (excluding the natural cavity) with irradiation of incoherent light having a wavelength in the range of 600 nm to 760 nm device of.

3.2 Effective irradiated face

The manufacturer's prescribed treatment surface includes information on the area and shape of the treatment surface and the irradiation distance and irradiation angle associated with it.

3.3 Effective surface temperature sensor

A signal sensing device comprising a connection portion with a device for monitoring the temperature of an effective irradiating surface.

3.4 Effective red light irradiance

The irradiance of the irradiated surface is equivalent to the irradiance assessed in the range of 600 nm to 760 nm,

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

GB 9706.283-2022|YY 9706.268-2022

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