DSF/PREN IEC 60601-2-91
Particular requirement for basic safety and essential performance of non-thermal plasma wound treatment equipment
| Organization: | DS |
| Status: | pending |
| Page Count: | 70 |
| ICS Code (Other medical equipment): | 11.040.99 |
| ICS Code (Hospital equipment): | 11.140 |
scope:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of NON-THERMAL PLASMA 112 WOUND TREATMENT EQUIPMENT hereafter referred to as ME EQUIPMENT. 113 NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT apples to chronic and acute wounds as well as diverse 114 skin and itching diseases 115 HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of 116 this document are not covered by specific requirements in this document except in 7.2.13 of the general 117 standard. 118 This document does not apply to: 119 - ME EQUIPMENT intended for the haemostasis in biological tissue by using ionized gas ( see IEC 60601-2-76
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