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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 12-102
ANSI IES  RP-27.2-00/R17
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques
The ANSI/IES RP-27 series of standards applies to all electrically powered sources of optical radiation that emit in the wavelength range from 200 nm to 3,000 nm. The standards do not apply to any lasers or to those light emitting diodes used in optical fiber communication systems.

This standard is to be used by the radiometrist for guidance regarding special problems related to photobiological hazard measurements. Additionally, specific recommendations are included to provide consistency and to reduce test design time and effort.

It is impractical for this standard to teach all of the concepts or provide all experience needed to make accurate photobiological safety measurements.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§878.4635 Suntan Bed Class 2 REF
§878.4635 Suntan Lamp Class 2 REG
§878.4635 Tabletop Sunlamp System Class 2 REH
§878.4810 Powered Laser Surgical Instrument Class 2 GEX
§878.4810 Massager, Vacuum, Light Induced Heating Class 2 NUV
§878.4810 Laser, Dental, Soft Tissue Class 2 NVK
§878.4810 Laser, Benign Prostatic Hyperplasia Class 2 OEL
§878.4810 Light Based Over The Counter Wrinkle Reduction Class 2 OHS
§878.4810 Light Based Over-The-Counter Hair Removal Class 2 OHT
§878.4810 Over-The-Counter Powered Light Based Laser For Acne Class 2 OLP
§878.4810 Powered Light Based Non-Laser Surgical Instrument Class 2 ONE
§878.4810 Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Class 2 ONF
§878.4810 Powered Laser Surgical Instrument With Microbeam\Fractional Output Class 2 ONG
§878.4810 Neurosurgical Laser With Mr Thermography Class 2 ONO
§878.4810 Laser Assisted Lipolysis Class 2 ORK
§878.4810 Laser, Cellulite Appearance Class 2 OYW
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Pejman Ghassemi
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
IES Illuminating Engineering Society https://www.ies.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.