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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 12-356
Standard(Included in ASCA)
IEC  60601-2-22 Edition 4.0 2019-11
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications, intended for use on humans or animals, classified as LASER PRODUCT of CLASS 1C where the ENCLOSED LASER is of CLASS 3B or 4, or CLASS 3B, or CLASS 4.

MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS which incorporate lasers as sources of energy being transferred to the PATIENT or animal and where the lasers are specified as above, are referred to as "laser equipment" in this document.
NOTE 1 LASER PRODUCTS for these applications classified as a Class 1, Class 1M, CLASS 2, Class 2M or CLASS 3R LASER PRODUCT, are covered by IEC 60825-1:2014 and by the general standard.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies to ME EQUIPMENT and to ME SYSTEMS, as relevant. Hazards inherent in the intended physiological function of laser equipment within the scope of this document are not covered by specific requirements in this document except in 7.2.13, Physiological effects, of the general standard.
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.

Note: There is an editorial error to be corrected in the revision. The third sentence of subclause e) refenced sub clause 4.7.3 of IEC 60825-1 Edition 3.0 2014-05, which does not exist. The reference should be sub clause 6.7.3 instead.
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FDA recognition of IEC 60601-2-22 Edition 3.1 2012-10 [Rec# 12-268] will be superseded by recognition of IEC 60601-2-22 Edition 4.0 2019-11 [Rec# 12-356].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
§1040.10 Laser products.
§1040.11 Specific purpose laser products.
§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.

Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56): Guidance for Industry and Food and Drug Administration Staff, Issued Feb. 2023.

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
 Pejman Ghassemi
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.