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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 033 Date of Entry 01/14/2014 
FR Recognition Number 12-268
Standard(Included in ASCA)
IEC  60601-2-22 Edition 3.1 2012-10
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser equipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinary applications, intended for its use on humans or animals, classified as a CLASS 3B or CLASS 4 LASER PRODUCT as defined by 3.22 and 3.23 in IEC 60825-1, hereafter referred to as LASER EQUIPMENT.

Throughout this International Standard, light emitting diodes (LED) are included whenever the word "laser" is used.
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FDA recognition of IEC 60601-2-22 Edition 3.1 2012-10 [Rec# 12-268] will be superseded by recognition of IEC 60601-2-22 Edition 4.0 2019-11 [Rec# 12-356]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-268] until July 04, 2027. After this transition period, declarations of conformity to [Rec# 12-268] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§878.4810 Laser For Gastro-Urology Use Class 2 LNK
N/A Laser, Neurosurgical Class 3 LKW
N/A Laser, Neurosurgical, Argon Class 3 LLF
N/A Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary Class 3 LOI
N/A Device, Angioplasty, Laser, Coronary Class 3 LPC
N/A Implantable Cardioverter Defibrillator (Non-Crt) Class 3 LWS
N/A Excimer Laser System Class 3 LZS
N/A System, Laser, Transmyocardial Revascularization Class 3 MNO
N/A System, Laser, Photodynamic Therapy Class 3 MVF
N/A System, Laser, Fiber Optic, Photodynamic Therapy Class 3 MVG
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.