YY/T 1534-2017Measuring methods for optical radiation safety classification of medical LED equipment (English PDF)
医用LED设备光辐射安全分类的检测方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 28, 2017
Implementation date
April 1, 2018
Scope
YY/T 1534-2017 is the English-translated version of 医用LED设备光辐射安全分类的检测方法.
YY/T 1534-2017 is the Chinese pharmaceutical industry standard that gives the measuring methods for the optical radiation safety classification of medical LED equipment with one or more sources emitting between 200 nm and 3000 nm.
It sets out the measurement geometry and the quantities to be determined - the radiance and irradiance weighted for the photobiological hazards - and the way the equipment is assigned to a risk group.
It does not apply to ophthalmic instruments or to infant phototherapy equipment. Issued on 28 March 2017, it has applied since 1 April 2018.
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Document preview — YY/T 1534-2017
National Standard of the People's Republic of China
- ICS
- 11.040.99
- Classification
- C 40
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the wavelength range of 200nm ~ 3000nm, with one or more light sources of medical LED equipment, optical radiation safety Full classification of detection methods.
This standard does not apply to ophthalmic apparatus and infant phototherapy equipment.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB 7247.1-2012 Safety of laser products - Part 1 Classification of equipment, requirements (IEC 60825-1:2007, IDT) Photobiological safety of lamps and lamp systems
IEC 60601-2-57:2011 Medical electrical equipment - Part 2-57 - Non-lasers for treatment, diagnosis, monitoring and cosmetology/aesthetics Basic requirements for safety and basic performance of light source equipment (Particularrequirementsforthebasicsafetyandessential performanceofnon-laserlightsourcequipmentintendedfortherapeutic, diagnostic, monitoringand cosmetic/aestheticuse)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Angle of reception angle
The detector responds to the light radiation plane angle.
Note 1. The acceptance angle can be controlled by using aperture or optics.
Note 2. The unit is radian (rad).
Note 3. Rewrite IEC 60601-2-57:2011, Definition 2.1.101.
3.2 Aperture aperture
The aperture used to determine the area through which radiation is to be measured. [GB 7247.1.2012, Definition 3.9]
3.3 Antenna angularsubtense; alpha
The viewing angle of the observer's eye or measuring point by the light source or by the apparent light source.
Note 1. In this standard, the angle of intersection refers to the whole angle, not the half angle.
Note 2. The unit is radian (rad).
Note 3. Rewrite IEC 60601-2-57:2011, Definition 2.1.102.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
IEC 60601-2-57:2011
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Related Standards
GB 7247.1-2012 — Safety of laser products - Part 1: Equipment classification and requirements
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