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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 062 Date of Entry 05/29/2024 
FR Recognition Number 12-355
Standard(Included in ASCA)
IEC  60601-2-57 Edition 2.0 2023-07
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, cosmetic and 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FDA recognition of IEC 60601-2-57 Edition 1.0 2011-01 [Rec# 12-242] will be superseded by recognition of IEC 60601-2-57 Edition 2.0 2023-07 [Rec# 12-355].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 http://www.iec.ch/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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