DS/EN 60601-1
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
| Organization: | DS |
| Publication Date: | 15 October 2013 |
| Status: | active |
| Page Count: | 142 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
1.1 * Scope Delete the fourth paragraph. Replace the fifth paragraph with: The IEC 60601 series does not apply to: - In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series 2); - implantable parts of active implantable medical devices covered by ISO 14708series 3); or - medical gas pipeline systems covered by ISO 7396-1 4).5 NOTE 2 ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and alarm signals.
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