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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Recognition 07/09/2014 
FR Recognition Number 12-273
Standard
IEC 60825-1 Edition 2.0 2007-03
Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
Scope/Abstract
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

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 both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1.

This standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability.

Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
Unclassified Device, Angioplasty, Laser, Coronary Class 3 LPC
Unclassified Device. Laser Peripheral Angioplasty Class 3 LWX
Unclassified Excimer Laser System Class 3 LZS
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
§874.4490 Laser, Microsurgical Argon, For Use In Otology Class 2 LXR
§874.4490 Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology Class 2 LMS
§874.4500 Laser, Ent Microsurgical Carbon-Dioxide Class 2 EWG
§874.4500 Laser, Neodymium:Yag, Pulmonary Surgery Class 2 LLO
§878.4810 Laser For Gastro-Urology Use Class 2 LNK
§878.4810 Powered Laser Surgical Instrument Class 2 GEX
§884.4550 Laser, Neodymium:Yag For Gynecologic Use Class 2 LLW
§884.4550 Laser, Surgical, Gynecologic Class 2 HHR
§886.4390 Laser, Ophthalmic Class 2 HQF
§886.4392 Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla Class 2 LXS
§886.4670 Laser, System, Phacolysis Class 2 MXO
§886.4690 Photocoagulator And Accessories Class 2 HQB
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Richard P. Felten
  FDA/OMPT/CDRH/ODE/DSD/GSDB1/
  301-796-6392
  richard.felten@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Radiology
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