| 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)] |
| Recognition Date | 2014-07-09 |
| Recognition List | 036 |
| Recognition Number | 12-273 |
| 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 |
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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.
| 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 |
| There is no relevant guidance developed at this time. |