Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

028

Date of Entry 03/16/2012

FR Recognition Number

12-242

Standard

(Included in ASCA)

IEC 60601-2-57 Edition 1.0 2011-01
Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

Scope/Abstract

This International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual photobiological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment (LS EQUIPMENT).

This particular standard does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy.

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.

Transition Period

FDA recognition of IEC 60601-2-57 Edition 1.0 2011-01 [Rec# 12-242] will be superseded by recognition of IEC 60601-2-57 Edition 2.0 2023-07 [Rec# 12-355]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-242] until July 04, 2027. After this transition period, declarations of conformity to [Rec# 12-242] will not be accepted.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§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
§878.5400	Fat Reducing Low Level Laser	Class 2	OLI
§890.5500	Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy	Class 2	NHN
N/A	System, Laser, Photodynamic Therapy	Class 3	MVF

Relevant FDA Guidance and/or Supportive Publications*

1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

2. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices, Issued July 1995.

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 Contacts

Wlodzimierz Strzelecki

FDA/OC/CDRH/OPEQ/OIDRH/DRH/MREPB/

301-796-6939

WOODY.STRZELECKI@FDA.HHS.GOV

Pejman Ghassemi

CDRH/OPEQ/OIDRH/DRH/MREPB/

240-402-1313

Pejman.Ghassemi@fda.hhs.gov

Standards Development Organization

IEC

International Electrotechnical Commission