DSF/FprEN 60601-2-2
Medical electrical equipment -- Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
| Organization: | DS |
| Status: | pending |
| Page Count: | 82 |
| ICS Code (Surgical instruments and materials): | 11.040.30 |
scope:
Clause 1 of the general standard2) applies, except as follows: 201.1.1 * Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF SURGICAL EQUIPMENT as defined in 201.3.222. HF SURGICAL EQUIPMENT having a RATED OUTPUT POWER not exceeding 50 W (for example for micro-COAGULATION, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements.
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