ANSI IESNA RP-27.3-17 Medical Standard

Recommended Practice For Photobiological Safety For Lamps - Risk Group Classification And Labeling

RP-27.3-17

Standard Organization: ANSI IESNA

ANSI IESNA RP-27.3-17
Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling

Recognition Number

Radiology

Recognition Date

2019-01-14

Recognition List

051

Recognition Number

12-321

Extent

Complete standard

Standards Orgs

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STG

Radiology

FDA Tech

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This standard covers the classification, labeling and informational requirements for lamps that emit optical radiation in the wavelength range from 200 nm to 3,000 nm, with exception for LED diodes used in optical fiber communication systems and for lasers. Lamps included are incandescent filament lamps including tungsten halogen types and incandescent heating sources, low pressure discharge lamps, high intensity discharge (HID) lamps, short arc lamps, carbon arcs, electroluminescent lamps, lightemitting diodes (LEDs), organic light emitting diodes(OLEDs) and laser-driven broadband sources. For the purposes of this document, induction lighting is classified under fluorescent lamps and plasma lighting is classified under HID lamps. Federal mandatory requirements for lamps subject to specific Federal Regulations take precedence over requirements included in this consensus standard.

Code of Federal Regulations:

Regulation Number

Device Name

Device Class

Product Code

§878.4810

Laser Assisted Lipolysis

Class 2

ORK

§878.4810

Laser, Benign Prostatic Hyperplasia

Class 2