IEC - 60601-1
Safety of medical electrical equipment Part 1: General requirements
| Organization: | IEC |
| Publication Date: | 1 January 1977 |
| Status: | inactive |
| Page Count: | 396 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
This Standard applies to MEDICAL ELECTRICAL EQUIPMENT intended for use by or under the supervision of qualified personal in the PATIENT ENVIRONMENT, or related to the PATIENT in such a way that the safety of persons or animals in that environment is directly affected.
This Standard specifies requirements for the transport, storage, installation, use and maintenance of such EQUIPMENT under the environmental conditions specified in Sub-clause 14 or by the manufacturer or as prescribed in Particular Standards.
Although this Standard is primarily concerned with safety, it contains some requirements regarding reliable operation where this is connected with safety.
Dangers resulting from the physiological effects produced by the intended function of EQUIPMENT covered by this Standard are not considered.
A (non-exhaustive) survey of MEDICAL ELECTRCAL EQUIPMENT is given in Appendix A.
Document History