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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 033 FR Publication Date: 01/14/2014 

Part B: Supplementary Information

Recognition Number 12-268: 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. (Radiology)

Date of Standard: 2012. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
Applies to laser equipment for medical applications, classfied as a class 3B or a class 4 laser product according to the classification in IEC 60825-1.
Processes Affected:
510(k), PMA, IDE, Initial reports
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard

FDA recognition of IEC 60601-2-22 Third Edition 2007-05 [Rec# 12-208] will be superseded by recognition of IEC 60601-2-22 Edition 3.1 2012-10 [Rec# 12-268]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 12-208] until August 1, 2016. After this transition period, declarations of conformity to [Rec # 12-208] will not be accepted.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Device, Angioplasty, Laser, Coronary Class 3 LPC
Unclassified Excimer Laser System Class 3 LZS
Unclassified Implantable Cardioverter Defibrillator (Non-Crt) Class 3 LWS
Unclassified Laser For Gastro-Urology Use   LNK
Unclassified Laser, Dental   LYB
Unclassified Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary Class 3 LOI
Unclassified Laser, Neurosurgical Class 3 LKW
Unclassified Laser, Neurosurgical, Argon Class 3 LLF
Unclassified System, Laser, Fiber Optic, Photodynamic Therapy Class 3 MVG
Unclassified System, Laser, Photodynamic Therapy Class 3 MVF
Unclassified System, Laser, Transmyocardial Revascularization Class 3 MNO
FDA Technical Contact:
 Richard P. Felten
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1436
  Silver Spring MD 20993
  301/796-6392
  email: richard.felten@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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