CENELEC - EN 60601-1
Medical Electrical Equipment Part 1: General Requirements for Safety
Organization: | CENELEC |
Publication Date: | 1 August 1990 |
Status: | inactive |
Page Count: | 200 |
ICS Code (Medical equipment in general): | 11.040.01 |
scope:
This Standard applies to the safety of MEDICAL ELECTRICAL EQUIPMENT (as defined in Sub-clause 2.2.15). Although this Standard is primarily concerned with safety, it contains some requirements regarding reliable operation where this is connected with safety.
SAFETY HAZARDS resulting from the intended physiological function of EQUIPMENT covered by this Standard are not considered.
Appendices in this Standard are not mandatory unless made so by an explicit statement in the main text.
Object
The object of this Standard is to specify general requirements for the safety of MEDICAL ELECTRICAL EQUIPMENT and to serve as the basis for the safety requirements of Particular Standards.
*Particular Standards
A Particular Standard takes priority over this General Standard.
Environmental conditions
See Section 2.
Collateral Standards
In the IEC 601 series, Collateral Standards specify general requirements for safety applicable to:
- a group of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment);
- a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT not fully addressed in the General Standard (e.g. electromagnetic compatibility).
If a Collateral Standard applies to a Particular Standard, then the Particular Standard takes priority over the Collateral Standard.
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