News

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  It's expected the 2nd edition will be withdrawn in either 3 or 5 years.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.

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.

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.

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.

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.

OBCM Brochure Released

A new pdf brochure is available from the Documents Download page, which provides an overview of O'Brien Compliance Management

OBCM To Exhibit at MD&M, East

OBCM will be at booth 1864 at the Jacob K. Javits Convention Center, 13-15 June 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.

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.

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.

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.

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.

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.

OBCM Opens New Test Laboratory

The OBCM office now includes a test laboratory for prototype testing.  For details, see our Services page.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.   

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.