Recognized Consensus Standards
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IEC 60601-2-22 Edition 3.1 2012-10
Standard Organization:
| 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 |
| Recognition Date | 2014-01-14 |
| Recognition List | 033 |
| Recognition Number | 12-268 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | Radiology |
| FDA Tech | Richard P. Felten FDA/OMPT/CDRH/ODE/DSD/GSDB1/ 301-796-6392 richard.felten@fda.hhs.gov |
Rationale:
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Scope:
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.
Code of Federal Regulations:
| 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, 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 |
| §878.4810 | Laser For Gastro-Urology Use | Class 2 | LNK |
FDA Guidance:
U.S. Food & Drug Administration
