Date |
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post-2005 |
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31 Dec 2005 |
IEC 60601-1:2005-12 Published
The new 3rd Edition of IEC 60601-1, the international
standard for basic safety and essential performance of
electrical medical equipment, has been published by the
IEC. Its transition dates with the current 2nd Edition are
still being worked out by regulatory authorities like the EU,
and FDA; standards organizations like CENELEC, AAMI, and CSA;
and certification organizations. It's expected everyone
will be following CENELEC's lead, so that a common set of
transition dates will be established. It's expected the
2nd edition will be withdrawn in either 3 or 5 years.
After this time, all new medical designs will need to comply
with the 3rd edition.
The 3rd edition changes from a test verification orientated
standard into a process based standard, requiring an ISO 14971
risk management driven design process. This is consistent
with regulatory requirements, so while a large change on the
surface, should be consistent with existing manufacturing
practices. Perhaps the organizations most effected by this
philosophical change are test and certification organizations,
who will need to establish policies for reviewing a
manufacturer's risk management file. The new standard
still provides a substantial amount of specific, verifiable
requirements, (test and examination compliance criteria), which
can be used to presume an acceptable level of risk. In
this sense, the 3rd edition plays the same role as the 2nd
edition.
The concept of safety has been expanded from Basic Safety to
also include Essential Performance. A manufacturer will
now be required to identify features and functions that must
perform properly to protect the patient from an unacceptable
risk of harm. While the general standard provides some
guidance and examples to assist a manufacturer with their risk
management process, the collaterals and particular, which are in
the process of being aligned with the new 3rd edition, are
expected to provide specific examples.
The 3rd edition updates requirements in a number of areas,
including electrical insulation, motion control, mechanical
safety factors, and hot surfaces limits. There will now be
cases where more designs will be considered adequate. For
a brief overview of 3rd edition changes you can download a
3rd Edition Introduction,
given by Frank O'Brien, president of OBCM, to the MassMEDIC
Society in March 2005. Frank also serves as a instructor
for UL's
public or private educational seminars on the 3rd Edition.
Frank was the secretary of SC62A, working group 17, responsible
for drafting the mechanical requirements, and as secretary, also
participated on the oversight committee, SC62A. |
28 Nov 2005 |
Risk Management Featured in Doonesbury
Garry Trudeau's main purpose may have been to raise a
chuckle, but there's more than a small grain of truth in its
message as well. It's a great example of why you
want some clinical and user representation in your hazard
identification process. It also illustrates why it's so
important to continue to use market and user feedback to improve
your design. |
11-12 Oct 2005 |
IEC 60601 Technical Seminar, Boston Area
UL
and Quadtech
are hosting a technical seminar on Designing for Compliance with
IEC 60601-1, at the Quadtech facility in Maynard, MA.
Frank O'Brien, president of OBCM, will be an instructor. |
26 Sep 2005 |
OBCM Quoted in Regional Focus on New England -- MPMN,
September 2005
The September 2005 issue Medical Product Manufacturing
News (MPMN) featured a focus on
New England Medical Device Suppliers. Frank O'Brien,
president of OBCM, was interviewed for this piece, and was quote
as saying, "with medical device manufacturing, it always comes
down to venture capital and doctors with ideas," in response to
why New England has the 2nd highest concentration of medical
device manufacturing, although only 5% of the population.
Of course New England is rich with both venture capital, and
medical universities. This drives medical device
innovation, which in turn creates a market for firms providing
contract design, and manufacturing support. OBCM fills the
regulatory compliance support role. OBCM is proud to be
part of the reason New England remains a leader in medical
device innovation. |
28 Aug 2005 |
OBCM Working with Top Innovative Medical Technologies --
MD&DI, July 2005
According to Medical Device & Diagnostic Industry (MD&DI),
July 2005, the
Top 10 Technologies in medicine having the biggest effect
are: 1) implantable elution devices (drug assisted stents), 2)
carotid artery stents, 3) heart assist devices, 4) artificial
bone and skin drafts, 5) artificial orthopedic disks, 6) nucleic
acid-based IVD's, 7) medical lasers, 8) medical imaging
technology, 9) wireless technology, and 10) computer-assisted
surgery.
Of these 10, 6 involve electrical medical device
technologies. OBCM has clients working in 5 of the top 6:
- Thoratec makes heart assist devices, (LVAD's),
- IQuum and HistoRX make nucleic acid-based IVD's,
- Breakaway Imaging provides real-time CT type imaging
during surgery
- Smith & Nephew makes wireless and voice recognizing
operating room control systems
- MAKO Surgical makes computer assisted surgical equipment
OBCM is also working with Boston Scientific and Novelis on
innovative alternatives to clearing artery blockage. Prior
to forming OBCM, Frank O'Brien has worked with laser
manufacturers, Laserscope and Coherent. Frank was also
instrumental in Intuitive Surgical receiving their US and
European regulatory approvals on their ground breaking computer
assisted surgical device, the da Vinci.
If your firm is working on innovative medical technologies,
and is seeking expert advise on how medical regulatory and
safety requirements apply, there's no better fit than OBCM. |
7 Aug 2005 |
OBCM Brochure Released
A new pdf brochure is available from the
Documents Download page, which provides an overview of
O'Brien Compliance Management |
13-15 Jun 2005 |
OBCM To Exhibit at MD&M, East
OBCM will be at booth 1864 at the Jacob K. Javits Convention
Center, 13-15 June 2005. |
17-18 May 2005 |
IEC 60601 Technical Seminar, Chicago Area
UL
and Quadtech are hosting a technical seminar on Designing for
Compliance with IEC 60601-1, at the UL Northbrook, IL office.
Frank O'Brien, president of OBCM, will be an instructor. |
10-11 May 2005 |
IEC 60601 Technical Seminar, Orange County Area
UL
and Quadtech are hosting a technical seminar on Designing for
Compliance with IEC 60601-1, at the UL Brea, CA office.
Frank O'Brien, president of OBCM, will be an instructor. |
14-15 Apr 2005 |
IEC 60601-1, 3rd Edition Work in Williamsburg, VA
Frank O'Brien, president of OBCM, will be in Williamsburg attending
a SC 62A, Working Group 17 meeting. The venue is hosted by
the AdvaMed, and during a 2 week period will include meetings of
TC62, SC62A, and many of their numerous groups. Work is
beginning to align the particulars and collaterals with the new
3rd edition of the general standard. |
14 Mar 2005 |
Public Download Page added to OBCM Website
A Documents Download page has been
added to the website. A copy of the MassMedic presentation
giving an overview of IEC 60601-1, 3rd edition, is available. |
1 Mar 2005 |
Standards Update at March MassMEDIC Meeting
Frank O'Brien, president of OBCM, will be a speaker at the
March MassMEDIC meeting providing an Update on Medical Device
Regulatory and Safety Standards. |
15-18 Nov 2004 |
IEC 60601-1, 3rd Edition Work in London
Frank O'Brien, president of OBCM, will be in London attending
a SC 62A, Working Group 17 meeting. The agenda includes
resolving the comments to the 2CDV version of IEC 60601-1, 3rd
edition. |
6 Nov 2004 |
OBCM Opens New Test Laboratory
The OBCM office now includes a test laboratory for prototype
testing. For details, see our
Services page. |
19-20 Oct 2004 |
IEC 60601 Technical Seminar
UL
and Quadtech are hosting a technical seminar on Designing for
Compliance with IEC 60601-1, in the Boston area. Frank
O'Brien, president of OBCM, will be an instructor. |
14 Aug 2004 |
IEC 60601-1, 3rd Edition, 2CDV Approved
The 2nd Committee Draft (2CDV) of 60601-1 Ed. 3 was approved
by a wide margin, (21 approved (91% > 67%; 2 opposed (8% <
25%)). Thirteen National Committees submitted comments so
a lot of work remains, but it's on to the Final Draft
International Standard (FDIS), which is due by 15 November 2004,
and the final standard by April 2005. Frank O'Brien,
president of OBCM, works on one of the working groups drafting
this document, and therefore we are very informed about all
changes. |
20 Jul 2004 |
UL 61010-1 / CSA C22.2 No. 1010.1 / ISA 82.02.01 Released
UL, CSA, and ISA have released a common standard based on IEC 61010-1, 2nd edition;
the edition already required
by Europe. The new UL 61010-1 will replace UL
61010A/B/C-1, based on the IEC 61010-1, 1st edition. The
situation is similar for CSA and ISA. New
UL submittals can now use this standard, or still use the older
standard. New UL product submittals must use the newer UL
61010-1 by 1 Jan 2010, and any existing Listing will be
withdrawn on 1 Jan 2014 unless found to comply with new UL
61010-1. Details are in a UL bulletin dated 12 Jul
2004. Not mentioned was the transition dates for C-UL Listings,
but UL and CSA typically use the same dates. OBCM
recommends using the newer 2nd edition immediately, since this
is harmonized with Europe. OBCM has detailed knowledge of
this new standard, including all changes. |
20 Jul 2004 |
Withdrawal Date for UL 544 and UL 187 Postponed
UL has postponed the withdrawal date for UL 544 and UL 187
(medical and x-ray equipment) to 1 Jan 2010, (rather than the
original w/d date of 1 Jan 2005). Existing Listing to
these standards will stay in force, except in the case of some
stand-alone power supplies. However, all new submittals
and substantial changes to existing equipment must be evaluated
to UL 60601-1, (in force since 1 Jan 2003). UL 60601-1 is
based on IEC 60601-1, and is therefore the basic standard used
by most other international markets. It seems that C-UL
Listings to CSA C22.2 No. 114 (UL 187) will have a similar
postponement, dependent on CSA decisions, however indications
are that CSA will maintain the w/d date of 1 Jan 2005 for CSA
C22.2 No. 125 (UL 544). UL will be following CSA's lead
regarding the C-UL Mark. Details are in a UL bulletin
dated 30 Jun 2004. |
16 Jun 2004 |
Certification Database Links
Added certification database links for UL, CSA, VDE, and
Semko to Links page. These are
great places to go for confirming components and accessories
you're purchasing really have the safety certifications you're
looking for. |
10 Jun 2004 |
Milken: Boston #1 Area for Medical Devices
According to a study released
this month by the Milken Institute, the San Diego metro area
ranks #1 for the biotech industry. When including
pharmaceuticals and medical devices in the mix, the Boston metro
area ranks #1. When considering just medical devices,
Boston is again #1. The study was paid for by someone
trying to promote SD. The SF/SJ/Oakland bay
area was treated as 3 metro areas, and the LA/Orange County area as 2 metro
areas, which of course helped SD and Boston in the rankings. The Boston metro area (Boston NECMA) included
Worchester, Brockton, Lowell, Lawrence, and Nashua). You can download complete study
here,
Milken Institute, (which requires a free login), or obtain
study from here,
Deloitte research. |
18-19 May 2004 |
IEC 60601 Technical Seminar
UL
and Quadtech
are hosting a technical seminar on Designing for Compliance with
IEC 60601-1, in Melville, Long Island, NY. Frank O'Brien,
president of OBCM, will be the instructor. |
10-11 Mar 2004 |
Draft IEC 60601-1, 3rd Edition Technical Seminar, AAMI/FDA
Frank O'Brien will be a speaker at the
14th
Annual AAMI/FDA International Conference on Medical Device
Standards and Regulation, in McLean, Virginia. Frank will
speak on the changes to the mechanical requirements in the 3rd
edition of IEC 60601-1. 300 participants are expected. |
3-4 Mar 2004 |
IEC 60601 Technical Seminar
UL
and Quadtech
are hosting a technical seminar on Designing for Compliance with
IEC 60601-1, in the Boston area. Frank O'Brien will be an instructor. |
28 Jan 2004 |
CE Marking Process for Medical and IVD Devices Presentation
Frank O'Brien will be speaker at the
Northeast Product
Safety Society Meeting. The topic will be the CE
marking process for medical and IVD devices. |
25-26 Sep 2003 |
Draft IEC 60601-1, 3rd Edition Technical Seminar, Frankfurt
Frank O'Brien will be speaker at the IEC SC62A, Technical
Seminar in Frankfurt, Germany. Seminar topic is the 3rd
Edition of IEC 60601-1, Basic Safety and Essential Performance
of Medical Electrical Equipment. Frank will speak on the
mechanical requirements. 150 participants are expected. |
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