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UPDATES: |
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2012/03/30 - Health Canada Implementation of the 3rd Edition of
IEC 60601-1, CSA C22.2 No. 60601-1:2008 |
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Health Canada has announced their Guidance on
Transition from the Second to Third Edition of the IEC 60601-1 Family
of Standards
This document provides the dates that compliance with
the 3rd Edition will be required for Health Canada.
It specifies that the deadline for the Base Standard
and Particulars that were published by June 1st, 2009, will be June
1st, 2012.
Particular Standards published after June 1st, 2009
will be given a 3 year transition period.
This means all the applicable Particular Standards for
a medical device must have been published for 3 years before the 3rd
Edition and applicable Particulars will be required.
The transition is similar to that of Europe, except
that devices currently on the market are "grandfathered" in,
under the Second Edition.
Please read the full document for details: Health
Canada IEC 60601 Ed3 Transition.pdf
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2012/03/24 - European Implementation of the 3rd Edition of EN
60601-1, under the MDD |
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Working Document for NBRG - Frequently Asked
Questions related to the Implementation of EN 60601-1:2006 with
respect to MDD 93/42/EEC
This document was published to clarify the many
questions that relate to the implementation of EN 60601-1:2006 within
the EU under the scope of MDD 93/42/EEC.
Please note that Question/Answer 3.3.9 may be
misleading, since any device that required a fire enclosure under the
2nd Edition (for example, required a flame rated plastic) do need to
meet the bottom openings requirements in the 3rd Ed. standard.
Link to Document: 3rd
Ed EN_60601-1_Implementation_NB-Med-comments_11 - V1.1.pdf
A summary is that the EU is giving 3 years after all
the applicable 3rd Edition EN 60601/80601 Particular Standard(s) for
a medical device are published to meet the new standard.
This applies to new devices, and existing devices,
sold on the European market (there is no "grandfathering"
of existing equipment on the market).
This does not apply to devices already sold to the end user,
only to manufactured devices, being placed on the market.
See the document referenced above for more specific information.
The following is a link to the European Publications
in the Official Journal (OJ) for Medical Standards, with the
published deadline dates for each standard (note, some standards do not
yet have a published deadline date).
The list of EN 60601/80601 standards start
approximately 2/3 of the way down the page.:
http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/
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2012/03/17 - IEC 60601-1, Ed. 3 New Risk Management Guidance and
Report Document Added |
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We have added the new Risk Management Guidance and
Report Document to the DOWNLOADS website page.
This new document provides guidance and documentation
to submit for a device evaluation to the 3rd Edition.
The document has been generated to provide the
required information to meet the requirements of the standard.
The locked pdf document is free to download, but the
Word document is only available to MECA clients.
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2011/09/20 - FDA and Symbols, Requiring Wording for All Symbols on
Device Labeling |
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Some information that we are receiving from clients indicates that
the FDA has been requesting that all symbols on the equipment
markings must include the English wording definition of the symbols
on the markings.
While this is not consistent with our interpretation of the
requirements, it is being required by some FDA reviewers.
Per US FDA News, Letters-To-File & Symbols:
"Letters-To-File: AdvaMed is reporting that the FDA
district offices are starting to review a company's 510(k)
Letters-To-File and if they disagree with your decision to not file
an amended/new 510(k) they will issue a warning letter and in some
cases FDA is forcing companies to recall the misbranded devices.
Symbols: FDA is expected to come up with a regulation that
will allow the use of some symbols. Right now their official position
is that symbols must be accompanied by words, otherwise your device
is considered misbranded and subject to recall. However it has been
noted that from a premarket standpoint some reviewers have been
allowing some symbols to pass their review, others have not.
Enforcement picked up starting about 2 years ago. So for now
it's hit-or-miss if they are used without corresponding words.
It is definitely buyer beware with the FDA right now. I
would not design a user interface with only symbols for 510(k)
clearance without a readily available backup plan that includes
symbols (just too risky). As you can see above, one may be
forced to RECALL symbol only designs."
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2011/08/12 - OSHA NRTL Mark Update for the Third Edition of IEC
60601-1, and AAMI ES 60601-1 |
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Kevin Robinson, at OSHA, commenting on the NRTL Mark and the IEC
60601-1, Ed. 3 standard:
Use of the certification mark that is identical to their NRTL
certification mark is currently not an issue under the NRTL program
(as long as the mark does not reference "NRTL"). We
understand that it does cause some confusion, and we are considering
some options for requiring a unique identifier for NRTL related
certifications, but that discussion is completely separate from the
ES60601-1 discussion.
Kevin Robinson
OSHA (robinson.kevin@dol.gov)
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2010/09/01 - MECA Has Moved the Engineering Department to a New Facility |
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MECA has moved to our Engineering department to new
location, 10 minutes from the previous location in Oak Creek.
The Oak Creek address is now for accounting only.
The old address (now for accounting only) is:
MECA
8350 S. Benjamin Dr.
Oak Creek, WI 53154
The new Engineering offices and Labs address is:
MECA
5060 W. Ashland Way
Franklin, WI 53132
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2010/06/11 - FDA Officially Recognizes 3rd Edition, and Specifies
Transition Date |
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The FDA now officially recognizes AAMI ES 60601-1:
2005 (based on IEC 60601-1, 3rd Edition) in the Federal Register
For 510(k) and PMA submissions in the United States,
they will continue to accept declarations of conformity to IEC 60601,
2nd Edition until June 30, 2013.
After this three year transitional period,
declarations of conformity to UL/IEC 60601-1, Ed. 2 will not be accepted.
The Link to FDA's website with details: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?id=28193
ANSI/AAMI ES60601-1:2005 includes the original IEC
text, plus U.S. differences/deviations.
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OLDER, RELEVANT INFORMATION: |
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2009/11/04 - MECA is now a TUV Rheinland Qualified Laboratory
for the Medical Standards |
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We are pleased to announce that MECA is now a
Qualified Laboratory for TUV Rheinland, under the Partner Test
Laboratory Program.
This allows us to offer TUV Certification services to
our clients.
MECA conducts the evaluation, testing, and writes the
report, and TUV conducts the Reviews and provides the authorization
to apply their safety mark.
See the ABOUT page for Certificate
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2008/11/17 - MECA is now a CB Testing Laboratory (ACTL) for
the Medical Category, under the CB Scheme |
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Medical Equipment Compliance Associates, LLC has been
accepted by the IECEE as an ACTL, associated with Underwriters
Laboratories, Inc.
This allows MECA to conduct testing under the medical
category (IEC 60601-1 and specified Collateral and Particular
standards) for the CB Scheme.
See the ABOUT page for Certificate
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2007/08/28 - MECA is now under the UL Third Party Test Data Program
(TPTDP), for the Medical Category |
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We are pleased to announce that MECA is now under the
full Third Party Test Data Program for Underwriters Laboratories, Inc.
This allows us to offer UL Classification and
Recognition services to our clients.
MECA conducts the evaluation, testing, and writes the
report, and UL Reviews the reports and provides the authorization to
apply their safety mark.
Prior to this, a level of required UL test witnessing
was required per project.
See the ABOUT page for Certificate
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2002/07/16 - MECA Founded |
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MECA (Medical Equipment Compliance Associates, LLC) founded by Brian Biersach
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