DSH 532 Accompanying documents
http://decisions.iecee.org/icons/ecblank.gifDSH 532
Accompanying documents
6.8.1
60601-1(ed.2);am1;am2
Standard(s)- (year and edition):
IEC 60601-1:1988 Ed.2
Am1+Am2
Sub clause(s):
6.8.1
Sheet n°: 532
Subject:
Accompanying documents
Key words:
Manuals, CD-ROM, Accompanying
documents
Decision taken at the 40th
meeting 2003
Question:
1) Is it required that accompanying documents shall be provided as hard copy?
2) What if accompanying documents are provided either on CD-ROM or Electronic File Format ?
Decision:
1) Accompanying documents may be in electronic format if acceptable to the USER..
2) Please note that at least that part of documentation concerned with safety precautions shall be
readable with the equipment in normal use and without interrupting a clinical procedure. A risk analysis
will indicate whether hard copy is necessary to cover emergency procedures e.g. resulting from power
failures.
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