Foreword
The text of document 62A/505A//FDIS, future edition 3 of IEC 60601-1, prepared bySC 62A, Common
aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in
medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC
as EN 60601-1 on 2006-09-12.
The following date was fixed:
latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement
(dop)
2007-07-01
This European Standard supersedes EN 60601-1:1990 and its amendments.
This EN 60601-1:2006 has been significantl y restructured compared to EN 60601-1:1990.
Requirements in the electrical section have been further aligned with those for information technology
equipment covered by EN 60950-1 and a requirement for including a RISK MANAGEMENT
PROCESS has been added. For an expanded description of this revision, see Cla use A.3.
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directives 90/385/EEC and 93/42/EEC. See Annex ZZ.
In this standard the following print types are used:
− requirements and definitions: in roman type;
− testspecifications: in italic type
;
−
informative material appearing outside of tables,such as notes, examples and references: in smaller type. Normative text
of tables is also in a smaller type;
−
TERMS USED THROUGHOUT THISSTANDARD THAT HAVEBEEN DEFINED IN C LAUSE 3 AND ALSO GIVEN IN
THE INDEX
: IN SMALL CAPITALS .
In referring to the structure of this standard, the term
clause means one of the seventeen numbered divisions within the table of contents, inclusive of
all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
subclause means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses
of Clause 7).
References to clauses within this standard are preceded by the term Clause followed by the clause
number. References to subclauses within this standard are by number only. In this standard, the
conjunctive or is used as an inclusive or so a statement is true if any combination of the conditions
is true.
The verbal forms used in this standard conform to usage described in Annex G of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
− shall means that compliance with a requirement or a test is mandatory for compliance with this
standard;
− should means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
− mayis used to describe a permissible way to achieve compliance with a requirement or test.
latest date by which the national standards conflicting
with the EN have to be withdrawn.
(dow)
2012-06-01
BS EN 60601-1:2006+A11:2011
EN 60601-1:2006+A11:2011 (E)
Licensed copy: graseby / hythe, Smiths Medical International Ltd, Version correct as of 27/03/2012 15:24, (c) The British Standards Institution 2012
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