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INFORMATION FOR EUROPEAN TRANSITION TO THE 3RD
EDITION (from CENELEC)
CENELEC/TC 62 has decided that, with the publication
of EN 60601-1:2006, compliance with EN 60601-1:1990 and its related
collateral standards will no longer give ‘presumption of
conformity’ with the European directives covered as of 2012-06-01.
This is the so called DOCOPOCOSS (Date Of Cessation Of Presumption
Of Conformity Of Superseded Standard), which is published in the
Official Journal of the European Union.
The CENELEC/TC 62 decision on the DOCOPOCOSS of
2012-06-01 was confirmed by the CENELEC Technical Board in October,
2009 (decision D135/C228). Publication in the Official Journal of the
European Union (OJEU) is necessary for this decision to enter into
force. This publication is expected in spring of 2010.
The part 2 standards referencing EN 60601-1:1990 will
remain to give presumption of conformity with the directives until
their own DOCOPOCOSS.
For those medical devices for which a part 2 exists
(i.e., a standard labeled EN 60601-2-x or EN 80601-2-x), the
transition period for that part 2 is decisive.
One must consider that a part 2 is essentially the
content of the main document (EN 60601-1), together with the content
of all the relevant collateral standards (all EN 60601-1-x), and then
modified by the content of the part 2. If the transition period of
the part 2 ends, for example, on 21 November 2011 then, after this
date, compliance with the old (‘superseded’) standard no
longer gives the presumption of conformity with the Essential
Requirements covered by the standard. In this situation, the 2012-06-01
date is not relevant for that device.
For products for which there is no (harmonized) part
2, compliance with the main standard and related collaterals can be
used to claim presumption of conformity. The DOCOPOCOSS date of
2012-06-01 implies that, after that date, compliance with EN
60601-1:1990 will no more give that presumption of conformity. Until
that date, since both EN 60601-1:1990 and EN 60601-1:2006 are listed
in the OJEU, either standard (with its set of collaterals, etc.) can
be used to claim presumption of conformity.
It is not possible to use the EN 60601-1:2006 with
the old collateral standards.
Since the main standard was substantially modified in
its revision to the 2006 version, the collateral standards had to be
modified as well. As a result, it is not possible to mix standards
from different “era”. You are encouraged to check the
normative reference clause of the collateral standards to find out
which edition of the general standard is related to that edition.
NOTES:
There are several collateral standards that relate to
EN 60601-1:1990, for which the same DOCOPOCOSS applies as it does for
EN 60601-1:1990.
These are: EN 60601-1-2:2001, EN 60601-1-3:1994, EN
60601-1-6:2004, and EN 60601-1-8:2004 (all with their respective amendments).
There are two more collateral standards that relate to
EN 60601-1:1990; these are EN 60601-1-1:2001 and EN 60601-1-4: 1996
(with A1:1999).
The relevant parts of these two collateral standards
were revised and updated, and included in EN 60601-1:2006.
As a consequence, the DOCOPOCOSS for these two
collaterals will be connected with the DOCOPOCOSS of the EN 60601-1:2006.
Not all EN 60601-standards adopted by CENELEC/TC 62 as
EN’s have been developed by IEC exclusively. Some standards in
this framework are the result of a joint effort between ISO and IEC,
which is made more visible by replacing the first digit in the
60601-numbering into an “8” (IEC/EN 80601 Standards).
The text in the foreword of EN 60601-1 says “However,
when Part 1 is used for appliances not covered by a part 2, EN
60601-1:1990 is not to be used after 2009-09-12".
This was included to stimulate manufacturers to
consider using the latest edition. In itself, that text does not
constitute any legal obligation or a change in the right to claim
presumption of conformity. The legal situation is that as long as EN
60601-1:1990 and its amendments have a current listing in the
Official Journal of the EU, they will continue to provide presumption
of conformity with the Essential Requirements of the MDD covered by
the standard. In spite of their listing in the OJ, harmonized
standards remain voluntary, so there is never a legal obligation to
use them.
SUMMARY:
All existing medical equipment being sold in Europe
must be evaluated/re-evaluated to the Third Edition of EN 60601-1
(2006), EXCEPT where there is an applicable Particular Standard (EN
60601-2-xx), where the date of withdrawal (DOCOPOCOSS) of that
Particular Standard would be the required date to have the medical
equipment evaluated/re-evaluated to the Third Edition of EN 60601-1
(2006), with the Particular(s)
This will be EXTREMELY difficult to meet for every
medical device on the market in Europe, as the certification agencies
are backlogged already.
It is difficult to anticipate what will happen when
the 2012-06-01 date arrives, and all of the certification agencies
are backlogged by 6 Months or longer.
Will there be another extension if companies are
backlogged getting through the certification agencies?
No one knows, but I wouldn't bank on it.
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