What's New

26 Jan 2012

KTL Engineer Working with OBCM

Ho Sung Lee, test engineer, at Korea Testing Laboratory (KTL), is visiting OBCM on an exchange program for 3 months.

"We're thrilled to have Ho Sung, and expect to learn much," explains Frank O'Brien, president of OBCM.  "Korea is an important market for medical devices, and KTL plays a pivotal role in device approvals, along with Korea FDA."

Ho Sung Lee adds, "It's my honor to be working with OBCM engineers and American medical device manufacturers.  I'm excited about the opportunity to see how IEC 60601-1, 3rd ed, and the associated risk management and usability engineering processes are being implemented.  In Korea, we're undergoing the same transitions."

Ho Sung will be returning to Seoul on 1 April 2012.

OBCM to host Shocktoberfest Open House, 14 Oct, 3p

Find out about our Open House here.

Job Opening for Product Safety Project Engineer

See our job opening posting on our About Us page.

OBCM Finalizes 2011 Training Schedule

OBCM has established themselves a global leader in IEC 60601 training.  This year's schedule has been finalized and has us in Korea, 3 European locations, and 3 US locations.  We constantly update our training to accomodate the latest changes, but this year we've redesigned our training to a 3 day course.  This extra day was something our feedback showed was necessary.  Participants wanted more time for exercises and to get more into the details of the requirements.  You can find more information about our training here.

O'Brien to Speak at FDA/AAMI Conference

Frank O'Brien will join with Chuck Sidebottom and discuss conformity assessment strategies for the 3rd edition to IEC 60601-1, the basic safety and essential performance standard for medical electrical equipment, required by Europe and Canada by June 2012.  The 21st annual AAMI/FDA international conference on medical devices and standards is being held 23-24 March 2011, in Herdon, VA.  Details are here, http://www.aami.org/meetings/isc/.

The presentation given is here.  There's details about the 3rd edition effective date here.  For guidance on how test labs will be assessing to the 3rd edition, see docs R8 and R9 here.

OBCM Comments Regarding Proposed FDA 510(k) Process

Frank O'Brien, president of OBCM was recently asked by Virgil Dickson, from FDAnews, about the recent comments made during a teleconference by Jeff Shuren, the director of the device division at the FDA, about how the European system allows unsafe devices on the market, "There are a number of differences between us and the European Union, they have a different standard than we do. Here in the U.S., the device has to be safe and effective. In Europe, a device has to be safe and it has to perform.

For example, if I have a laser that's supposed to treat an abnormal heart rhythm, you cut into the heart, in Europe, you have to show that when it cuts the heart, it cuts the heart well. In the U.S., you have to show when it cuts the heart it actually treats atrial fibrillation. It treats the abnormal heart rhythm - that patients get a benefit out of it.

"We also have to remember, 'Let's not throw the baby out with the bathwater,'" Shuren said. "Here in the U.S., devices are safe and effective, but in many cases - and we have a number of examples - devices that came on the market in Europe, when they had to show data here for the U.S. we found they have safety concerns, where they didn't work and they came off the market in Europe thereafter.

I'll leave this with a quote regarding one particular technology that was recently removed from the [EU] market. It was a breast implant that never made it here [in the U.S.]. This is from Nigel Mercer, a former president of the British Assn. of Aesthetic and Plastic Surgeons. He recently stated that, 'Under the EU system, the public are being used as guinea pigs.' We don't use our people as guinea pigs in the U.S," explained Jeff Shuren.

Frank O'Brien, OBCM, provided the following response to FDAnews, "First, FDA does a very good job of protecting the US public, and as it's a large market, FDA is very influential in protecting worldwide markets. Europe also does a very good job. While both are very good, neither the FDA nor European systems are perfect.

I would characterize the FDA comments, as quoted above, as in some cases misinformed. I will try to clarify the European regulatory system, and then offer some suggestions on how FDA might improve their 510(k) process.

To be on the European market a medical device needs to comply with 13 essential requirements for safety and performance, including adequate quality management, risk management, and usability engineering processes. The device must be safe and must fulfill its clinical purpose. A clinical evaluation includes known research and where needed, clinical investigations (e.g. a laser intended to treat atrial fibrillation, must fulfill its intended purpose). The clinical evaluation requirements were tighten up with Mar 2007 revisions (effective Mar 2010). To show compliance with the essential requirements a manufacturer will normally choose to comply with European standards harmonized to the essential requirements, which provide a presumption of compliance with the essential requirements. A checklist showing how a manufacturer has chosen to comply with applicable essential requirements, and all verification documentation, including test reports showing compliance with harmonized standards is compiled in the manufacturer's technical file. This is a very good system that correctly stresses management controlled life cycle processes, and the use of consensus standards to demonstrate compliance with the 13 high level requirements for safety and performance.

FDA is under some scrutiny for their pre-market notification, 510(k), process. Fundamentally this process relies on a new device to be found substantially equivalent to a predicate device already on the market, since 1968. While there are guidance documents that require FDA recognized consensus standards to provide a reasonable assurance of safety and efficacy, I would say needed standards are not recommended across all device panels consistently. Fundamentally as the 510(k) process is a bootstrapping type approval process relying on the iterative similarity of device technology and intended purposes to previously approved devices since 1968, it's not a scientific review of each new device on its merits. I would say FDA attempts to correctly provide such a review, with spotty consistency, and without the support of their regulatory mandate to restrict their review to substantial equivalence.

An easy fix for the 510(k) process would be to adopt the European Type Exam process described above. The European essential requirements are mirrored in the global harmonization task force list of "essential principals of safety and performance". The FDA recognized consensus standards could provide a "reasonable assurance" of compliance with the essential principals of safety and performance. The records associated with compliance would be retained in the manufacturer's "design history file" and "device master record" as FDA presently requires, and which is similar to the European technical file records. Both Europe and FDA rely on the same set of international ISO/IEC standards for their regional/national consensus list. A review could continue to be done within the present 90 day deadline. I would characterize FDA present proposal to redefine the 510(k) process as unnecessarily complex, and avoids the fundamental need to replace the regulation's need for a substantial equivalence finding with a scientific review to essential principals of safety and performance.

There's another fundamental difference between the European and US regulatory systems. The European system relies on their government agencies to accredit private third party bodies to assess and approve medical devices, thus relying on the free market to balance review resources and market approval wait times. The US system relies on the congressional budget process to provide adequate review resources. One must remember that lives can be lost by delaying the approval a good device, or inappropriately approving a bad device. Attention must be paid to both factors," explained Frank O'Brien.

OBCM to Provide Korean FDA and Korean Test Laboratory with IEC 60601-1, 3rd Edition Training

Frank O'Brien, OBCM is serving as instructor for a 2 day training conference on the 3rd edition of IEC 60601-1,  the basic safety and essential performance standard for medical electrical equipment, being offered by Korean FDA and Korean Test Laboratory on 6-7 April 2011, in Seoul, South Korea.  The conference is being followed by a special 2 day private training seminar for KTL.

New Support Material to Help Document Compliance with IEC 60601-1, 3rd Edition

OBCM has posted a Risk Management File Checklist, and additional background on the definitions of Essential Performance and Reasonably Foreseeable Misuse.  See Documents page for these documents, which can be downloaded.

OBCM Hires New Engineering Leader

OBCM is proud to announce the hiring of Gregory Chase, Engineering Leader.  Greg has over 15 years experience working in the product safety field, most recently as Lab Supervisor at Bureau Veritas.  After gaining expertise with our procedures and processes, Greg will be responsible for supporting our project engineers with review and training, and handling our more complex projects.

"With the new 3rd edition of the medical electrical equipment safety standard, we're seeing an increase in projects -- both for gap analysis of legacy devices, and for testing all products to the new requirements.  With the addition of Greg, we hope to keep ahead of demand and meet our customers' aggressive timelines," explains Frank O'Brien, president of OBCM.

How Test Labs Will Be Assessing Risk Management As Part of IEC 60601-1:2005, 3rd Edition Investigations

OBCM shares their observations following the Milan training that CB test labs attended.  See docs R8 and R9 here.

OBCM Moves to The Mill in North Chelmsford

Starting 11 August, OBCM is now located at The Mill in North Chelmsford, with Aprile's European Restaurant (formerly Bainbridge's).  The new suite is 1878 sq ft, including 517 sq ft (28%) for laboratory space.  There's a conference room, and offices for all staff.

"Since moving to New England in 2001, I've always loved how the landscape seems dominated by red brick mills along the many rivers and canals -- both for their beauty, and for their symbolism as relics from the dawn of the industrial revolution," explains Frank O'Brien, president of OBCM.  "The Mill we've chosen as our new location has been beautifully restored, and we hope will symbolize our continued commercial success.  We'll have room to accommodate at least 2 new staff members, should business growth warrant this.  We remain near Interstate 495 and Route 3, allowing our main customer base, greater Boston's medical device manufacturers, easy access to our regulatory support services."

Europe Sets 1 Jun 2012 Effective Date for Use of EN/IEC 60601-1, 3rd ed

Since Nov 2008, the 3rd edition has been on the List of Standards Harmonized to the Medical Device Directive that can be used to presume compliance with Essential Requirements in Medical Device Directive, but since 7 Jul 2010, we now have a cessation date for the use of the 2nd edition of 1 Jun 2012. This cessation date holds for general equipment that does not require the use of a particular standard (EN/IEC 60601-2--xx). The cessation date for the use of the 2nd edition aligned series of standards, for when the use of a particular is required, is the cessation date for the older 2nd edition aligned particular, (e.g. with -2-37 for ultrasound imaging, the cessation date is 1 Oct 2011; and with 2-2 for HF surgical equipment, the cessation date is 1 Apr 2012).

Also on the harmonized list since Nov 2008 are the Risk Management and Usability Engineering standards, ISO 14971, and EN/IEC 60601-1-6 / IEC 62366. These are required by EN/IEC 60601-1, 3rd edition, but by putting them separately on the harmonized list, they become required harmonized standards whether using 2nd or 3rd edition of EN/IEC 60601-1.

For a summary of the 3rd edition's effective dates and the impact, see https://docs.google.com/a/obcompman.com/Doc?docid=0AWHRGv-ISZrrZHQ3ejU1Yl8yNDlnZ3BiemtkZw&authkey=CJC0gJkH&hl=en.

OBCM is qualified and ready to provide 3rd edition testing, consulting, and training services.  Our president has been helping with the drafting of the 3rd edition since it's start in 1997.  OBCM is also a leading provider of a 2 day training course for development and test engineers, with training locations all over the world.

CFR Notice of FDA Recognition of IEC 60601-1:2005, 3rd Edition -- 30 Jun 2013 Cut Off Date For Use of 2nd Edition

US FDA has recognized the US adoption of IEC 60601-1:2005 in the form of ANSI/AAMI/ES 60601-1:2005 along with many collateral and particular parts of the 60601 series. A copy of the Federal Register notice published on 10 June is here. The FDA has set a transition period for acceptance of declarations of conformity to the second edition plus A1 and A2 of 30 June 2013. Full information on the extent of recognition including how they intend to deal with those aspects of 60601 that rely on risk management can be found here.

FDA Recognizes IEC 60601-1:2005, 3rd Edition

The US Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) is immediately recognizing IEC 60601-1, third edition. The announcement was made in early March at the 20th annual AAMI/FDA international standards conference by Carol Herman, director of the standards management staff at CDRH. The center's acceptance of the standard also includes "all collaterals and particulars," said Herman. She anticipates CDRH will publish a Federal Register notice by June 1, and from that point, there will be a three-year transition period. The third edition of IEC 60601-1 deals with the general requirements for basic safety and essential performance of medical electrical equipment.  The quote above comes from MDDI at: http://www.mddionline.com/blog/devicetalk/cdrh-officially-recognizes-iec-60601-1.

This announcement is significant to electrical medical device manufacturers as it puts FDA in line with Health Canada and the European Community for transitioning to the new 3rd edition alignment of the safety family of standards, IEC 60601, explains Frank O'Brien, president of O'Brien Compliance Management (OBCM). Canada is requiring compliance with these newer versions by June 2012. Europe accepts compliance with the new alignment, but has not formally announced a general cessation date for the older alignment. CENELEC, their standards body, has suggested June 2012 as a general cessation date. For some particular devices, such as ultrasound diagnostic equipment, Europe is requiring compliance by October 2010. The Canadian and European effective date applies to those manufacturers choosing to comply with recognized/harmonized standards to presume compliance with essential requirements/principals, which is the normal strategy employed by almost all manufacturers. Canada and Europe represent about 30% of the world market. With the FDA joining, this now represents about 75% of the world market, and a clear critical mass, encouraging other countries to join with a common effective date. It would not be surprising to see Countries like Japan, and Brazil follow with similar effective dates. The problem with different effective dates for the medical device manufacturer is that manufacturers need to comply with both alignments, rather than only the newer alignment, in order to sell globally.

The impact of the new 3rd edition alignment is that electrical medical device manufacturers' implementation of risk management and usability engineering (human factor) processes, something regulators were seeking even without the new IEC 60601 alignment, will now be part of an IEC 60601 assessment. When the manufacturer's risk assessment identifies it as appropriate, there are less stringent requirements for operator safety, mechanical safety factors, and surface temperatures. For equipment such as mobile carts, there are more stringent requirements for stability, and rough handling. For all equipment, the enclosure strength requirements are more stringent.

For electrical implant device manufacturers, the impact applies to the electrical non-implant accessories.  The applicable international family of safety standards for active implants, such as cardiac assist devices, neural-stimulators, and infusion pumps, is ISO 14708.  Except for neural stimulators, these standards aren't formally on the FDA recognized standards list.  In any case, FDA would probably accept that they represent the state of art for consensus standards.  This family of standards requires non-implant accessories, such as the chargers, programmers, network devices, etc, to comply with IEC 60601.  Therefore, for the non-implant accessories, the effect of transitioning to the 3rd edition is the same as for the other electrical medical device manufacturers.

OBCM is qualified and ready to provide 3rd edition testing, consulting, and training services.  Our president has been helping with the drafting of the 3rd edition since it's start in 1997.  OBCM is also a leading provider of a 2 day training course for development and test engineers, with training locations all over the world.

OBCM has new Location for Laboratory Operations

OBCM will now be operating out of two offices.  Engineering and Laboratory operations will now be at the new address 225 Stedman St, Suite 7, Lowell, MA, 01851.  Administrative operations will continue from the 12 Stedman St, Chelmsford, MA 10824 address.  The environmental chamber remains at 12 Stedman St.  Photos and directions are here.

"We're very pleased to have this new location for our electrical safety testing laboratory, " explains Frank O'Brien, the business owner.  "This step will allow us to have our engineers working in the lab, and to have visitors, something we haven't been able to do since October."

O'Brien Contracted by TUV Rheinland to Provide Training

Frank O'Brien, Principal Engineer at OBCM, recently provided training for TUV Rheinland customers to explain the impact of the recast Machinery Directive and IEC 60601-1, 3rd edition, to medical device manufacturers.  The training was held in Waltham, MA; and San Francisco, CA.  A briefer version of same material is available here.

OBCM Denied Home Occupation Permit; To Move to New Location

The Chelmsford Zoning Board of Appeals denied Frank O'Brien's application for a Special Permit.  The Variance application was withdrawn.  Within the next few weeks OBCM will move into a temporary commercial space.  Over the next 3 months, OBCM will move into a new permanent commercial location.

"This places us on a commercial track sooner than we planned, " explains Frank O'Brien, the business owner, "but will allow for more flexibility."

O'Brien Provides ZBA Additional Information

In preparation for the next Chelmsford Zoning Board of Appeals meeting on 14 Jan, Frank O'Brien, the business owner, has provided an architect certified floor plan, and a more concise rationale for the variance.  The amendment 3 (5.5 MB) is here.  The recompiled complete application (16.7 MB) is here.

OBCM to Rent Annex Office for Laboratory Use and Customer Visits

While waiting for ZBA approval of their applications, OBCM will be renting a small annex type office.  It will allow an employee other than the owner, to conduct safety testing, and will allow customer visits.  The annex will likely be about 2 miles away in a commercial district, on Stedman St, in Lowell.

"We need to get operations back to normal, " explains Frank O'Brien, the business owner.  "Renting this space will also allow the town of Chelmsford and our neighbors all the time they need to get familiar with what's allowed by the town's bylaws.  If the town eventually approves at least the Special Permit, this will be a temporary measure."

ZBA Requests Additional Information; Next Meeting is 14 Jan 2010

On 17 Dec 2009, Frank O'Brien had his hearing before the Chelmsford Zoning Board of Appeals.  He provided his side to the misinformation that's appeared in the press and on the internet.  He reviewed the 4 jobs he provides (including himself), and the 36 firms within 2 hours of Chelmsford his firm has helped with their regulatory approvals in the last 5 years.  He reviewed how he provides negligible ill effects to the neighborhood, speaking directly to the criteria in 195-102(B).  The rationale for finding favorably for a variance for an extra non-household employee was reviewed.  The neighbors, including their lawyer, voiced their views that the ill effects of accepting the application would amount to commercial zoning creep.  The board asked that the floor plan that shows the business uses not more than 25% of floor space be certified.  The board needs to research how to treat dual use floor space, such a bathroom, and a dining room being occasionally used for business purposes.  The next ZBA meeting is 14 Jan 2010.

Before the meeting, Frank O'Brien provided a 2nd amendment (2.9 MB) to his application in order to address recent questions that had been raised.  Frank also opened his house to inspection by 2 Westland Watchdog members.

O'Brien Amends Home Business Application

Today, Frank O'Brien filed an amendment to his application with the Chelmsford Board of Appeals.  The intent remains the same to obtain a Special Permit for Home Occupation, and Variance for 1 additional non-household engineer to work on premises.  The rationale for granting the variance was been updated to more clearly speak to the criteria in MGL Chapter 40A, Section 10.  A new table has been added to address the misinformation that's out there in the press and internet.  Anyone interested in reviewing the amendment (1.5 MB) is free to do so.

O'Brien Files Home Business Application with Chelmsford Town

On Monday Frank O'Brien, the business owner, filed an application with the Chelmsford Board of Appeals for a Home Occupation by Special Permit, and a Variance to allow 4 employees, including himself, the present size of the business.  The Special Permit will allow 1 non-household employee on premises, customer visits, and a business sign.  Should he be granted the Special Permit, he's explained that he'll waive his right to a business sign.  In return, he's asking that his neighbors and the town look favorably on his request for a variance to have up to 4 persons in his residence, including himself.  Frank has also distributed an open letter to abutting neighbors, assuring them that his small home based business will continue to blend in with the quiet residential character of neighborhood.  Anyone interested in reviewing application package (7.1 MB) or open letter to abutters (240 kB) is free to do so.

Explains Frank O'Brien, "Granting this proposal will allow a quiet home occupation with 4 professional employees, including myself, in what appears from the outside to be a quintessential New England, 4 bedroom residence, with a 2 car garage, on an almost 1/2 acre lot. From the perspective of any neighbor or passerby, the residence and its home business will seem consistent with a residential setting. Should the business stay on its current growth curve, it will move into a commercial setting in 3 to 5 years. The future long term impact on the town's tax base and jobs is potentially very positive."

The public hearing before the board is set for 17 December.  In the meantime, OBCM will continue to operate with both non-household employees working in their homes, and no customer visits, in accordance with Zoning Bylaws for a Home Occupation without a Special Permit.

OBCM Changes Structure to Comply with Local Zoning Regulations

The recent OBCM Open House has had some unintended consequences.  As a result of complaints from neighbors, the town has required OBCM to operate within home business limits without a Special Permit.  The business' 2 non-household, engineering employees now work off-site in their homes.  The business can no longer have customer visits.  The business owner performs all safety testing.  The business is still able to meet most customer expectations.

The business owner Frank O'Brien will be filing an application for a Special Permit.  If approved the business will be able to have 1 non-household employee on-site, and customers will be able to visit again.  If approved, OBCM's service will return to normal.  The town review with neighbor input will likely come in December.

"I used bad judgment in not seeking the needed Special Permit earlier, relates Frank O'Brien.  Hopefully our neighbors' and the town's response will stay proportional to our transgression.  We're new to Chelmsford since February 2009.  Prior to that we were a home business in Lowell with the proper permit.  We reached a point where we needed larger space.  We looked at commercial space and a larger home business option.  The home business option offered much less overhead, something very important for a small business starting out, especially during this economic slowdown.  We choose a home in Chelmsford whose prior owner had a home business, and up until 1976 had been a town school.  A move to a commercial site would have offered us a more professional image, but we felt it was a luxury we couldn't afford.  We hope that once we explain we're within the 25% floor space limit, our neighbors will be satisfied we're a small home business; one that can coexist with a quiet residential setting."

Open House Well Attended

We want to thank all for attending, and hope you enjoyed the presentation, lab tour, and trick or treat goodies bag.

For those who attended, as well as those who couldn't, the presentation link for what's ahead with medical device regulations.

OBCM to Host Open House, 9 Oct

All customers, present and prospective, are cordially invited to our Open House on 9 October 2009, from 3p to 7p.  This is our 5th year of operations.  We will be showing off our new offices and laboratory space, including many new equipment acquisitions.  We will be serving hors d'oeuvres and refreshments.

"With our recent equipment acquisitions, we're now one of the premier medical device test laboratories in the area," explains Chris Studley, Senior Engineer, OBCM.  "We can't wait to show off off our new lab."

OBCM Hires new Office Manager

OBCM proudly announces the hiring of a new Office Manager, Matthew O'Brien.  Matt provides customer support, including requests for quote, project status, and invoicing. He handles all our accounts payable and collectable.  He has a Bachelors degree in Economics and has worked for the banking industry.

"Having Matt will allow myself and our 2 safety engineers to focus on our medical device safety projects," explains Frank O'Brien, President of OBCM, "increasing our ability to deliver expert, responsive service."

OBCM Makes Capital Investment to Add New Patient Monitoring Test Capabilities

OBCM has recently purchased the following new test equipment:

• Environmental chamber, 8 ft3, -41 C to 190 C, 5 to 95 %RH
• Non-Invasive Blood Pressure Analyzer
• Pulse oximeter simulator
• ECG and pacemaker simulator
• Arbitrary function generator (for simulating complex heart rhythms)
• Circulating refrigerated bath, 6 L, -25 to 150 C

"The need we've identified is to be able to provide safety and performance testing for multifunction monitors without the need to use the manufacturer's in-house patient simulation devices.  This allows the manufacturer's development department to remain focused on their development tasks, while we can take care of their verification testing," explains Chris Studley, Senior Engineer of OBCM.  "We see this type of work picking up, particularly due to the transition to the new 3rd edition, IEC 60601-1:2005, which will become effective for Canada in June 2012, and for Europe perhaps by 2014, or as the particular standards become effective.  The new particular standards for each monitoring function are including more performance testing.  All legacy devices, as well as new devices, will need to be tested to these new requirements."

For details on OBCM's Testing Services, see our Services page.

OBCM Moves Into New Office and Laboratory

OBCM has moved into its new facility at 12 Stedman St, Chelmsford, just north of exit 34 of Interstate 495, and south of exit 31 of Route 3. 

The test laboratory is powered by a 100 A subpanel.  For additional information about our medical product safety test laboratory, see About Us page.

"We're very proud our growth has warranted this new facility," exclaims Frank O'Brien, President of OBCM.

Europe Announces Option to Use 3rd Edition; Requires Risk and Usability Whether 2nd or 3rd Edition Chosen

Starting on 27 Nov 2008, Europe will accept compliance with the 2nd or 3rd edition of IEC 60601-1 for the presumption of compliance with Essential Requirements of Medical Device Directive.  This was made official with the addition of the 3rd edition, EN 60601-1:2006 (IEC 60601-1:2005), and it's 3rd edition aligned EMC collateral, EN 60601-1-2:2007 (IEC 60601-1-2:2007), to the EU Harmonized Standards list. 

No cessation date with the 2nd edition has been announced.  It's expected that it will be the cessation of 2nd edition aligned particular standards that will define the date by which particular medical equipment must comply with 3rd edition.  For example, for Ultrasound equipment, the effective date for when you must meet 3rd edition starts 1 Oct 2009, since that's the cessation date for the 2nd edition aligned EN 60601-2-37:2001 + A1:2005 + A2:2005 (IEC 60601-2-37:2001 + A1:2004 + A2:2005).

The current Nov 2009 list includes new Harmonized Standards, EN ISO 14971:2007, and EN 62366:2008 (ISO 14971:2007 and IEC 62366:2007), for risk management and usability engineering processes, respectively.  As the inclusion of these 2 standards is effectively already requiring new 3rd edition requirements with the largest impact, the advantage of staying indefinitely with the 2nd edition is minimized.  The EN ISO 14971:2000 (ISO 14971:2000) ceases to provide a presumption of compliance with Essential Requirements on 31 Mar 2010.

See also the related article about a Canadian effective date for the 3rd edition of 1 Jun 2012.  A related FDA announcement is expected, but there's been no official notice.

OBCM has a training course to help with the transition to IEC 60601-1:2005, the 3rd edition, as well as a laboratory to perform testing.

Canada Announces 1 June 2012 Effective Date For 3rd Edition

In an email today to stakeholders, Health Canada, Therapeutic Products Directorate has announced an extended effective date for IEC 60601-1:2005, and its Canadian version, CAN/CSA-C22.2 No. 60601-1-08.  The new effective date is 1 Jun 2012, modifying the prior date of 15 Dec 2008.

Similar announcements are expected from US FDA and European Commission, but there's no news yet.

Currently medical devices are evaluated to the 2nd edition.  We now have a date when we'll need to transition to the 3rd edition.  This effective date will apply to new products in development, as well as current products already in production, which will be shipped after the effective date. 

OBCM has a training course to help with this transition, as well as a laboratory to perform testing.

Here's the text of the Canadian email:

From: DEVICE_LICENSING [mailto:device_licensing@hc-sc.gc.ca]
Sent: Thursday, October 16, 2008 9:59 AM
Subject: Date for Transition from the Second to the Third Editions of IEC 60601-1 and IEC 60601-1-2 on the Therapeutic Products Directorate's List of Recognized Standards

NOTICE

This is to amend the Notice of February 18, 2008, in which Health Canada announced the intent to remove the second editions of the recognized standards IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) and IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests) and the CSA adoptions: CAN/CSA-C22.2 No. 60601-1-08 [correct 2nd ed reference, CSA C22.2 No. 601.1-M90 + S1‑94 + B-90 (A2:1998)] and CAN/CSA-C22.2 No.60601-1-2-03 (R2008) from the Therapeutic Products Directorate's List of Recognized Standards and replace them with the third editions, effective December 15, 2008.

Since then, consultation with numerous stakeholders, including other regulatory bodies, registrars, standards organizations, and manufacturers, has identified the need to delay the withdrawal of the second editions of the IEC 60601 family of standards and the full recognition of the third editions.

In order to harmonize with our international regulatory partners, and to allow time for the development of the relevant collateral and particular standards, Health Canada intends to fully recognize the third edition of the IEC 60601 family of standards effective June 1, 2012. Until this date, Health Canada will continue to accept conformity to the second edition of IEC 60601-1 and the related collateral and particular standards (and their CSA Canadian adoptions) to demonstrate compliance with those aspects of the safety and effectiveness requirements of the Medical Devices Regulations addressed by these standards.

For further information on the List of Recognized Standards, please
contact:

Device Evaluation Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
Main Statistics Canada Building, Room 1605 150 Tunney's Pasture Driveway Tunney's Pasture, AL 0301H1 Ottawa, Ontario K1A 0K9
E-mail: DED_manager@hc-sc.gc.ca
Phone: 613-954-0297
Fax: 613-957-9969

OBCM hires new Project Engineer; Staff up to four

Due to a significant increase in new business, OBCM has hired it's fourth employee.  OBCM proudly announces the hiring of a new Engineering staff member, Pooja Soni.  Pooja is responsible for testing, report writing, and generally helping our medical device manufacturing customers with their compliance management tasks.  She has a Bachelors degree in Biomedical & Instrumentation Engineering with experience working with various diagnostic and therapeutic equipment.  Pooja also brings research experience with imaging, optical biosensors and radio therapy equipment.

"Maintaining our ability to deliver responsive, expert service is critical to us," explains Frank O'Brien, President of OBCM.  "We now have myself and 2 safety engineers available to help with medical device safety projects.  Anissa Herrick, our Account Executive, keeps our work flow on schedule."

OBCM Certified as TUV Rheinland Partner Test Laboratory

By successfully completing an audit to ISO/IEC 17025 and PTL requirements, OBCM is now a proud member of the TUV Partner Test Laboratory (PTL) Program.  As a PTL, OBCM can handle all submittal paperwork, including the submission of test data, for TUV Rheinland's review and audit; thereby efficiently integrating TUV's certification processes into OBCM's testing and reporting processes.

OBCM's TUV PTL Certificate is on the Lobby Wall.

OBCM announces seminar training schedule for 2008

From April 2008 to October 2008, 7 training seminars for IEC 60601-1, 2nd & 3rd editions are planned; 2 in the US, 1 in New Zealand, 2 in Japan, and 1 in Europe.

The average feedback score from past participants for "Would you recommend to others?" was 4.6 out of 5.

The 3rd edition was published in December 2005, and represents the state of the art for safety verification requirements for general electrical medical equipment.  In Canada, the Therapeutic Product Directorate has announced that electrical medical devices must comply by December 2008.  For the US and Europe, it's expected that equipment will be required to comply with the 3rd edition sometime after 2009 for equipment without a particular or collateral, or 2012 otherwise.  Many manufacturers are considering the 3rd edition as a design requirement for equipment currently in development.  We hope we'll be welcoming you to one of our upcoming practical training seminars.

There are specific details about the training seminar content and pricing here.

OBCM hires new Account Executive

OBCM announces the hiring of a new Account Executive, Anissa Herrick.  Anissa is responsible for customer support, including requests for quote, project management and invoicing.  Prior to joining OBCM in December 2007, Anissa worked 13 years as an Account Manager and Engineering Team Leader for Intertek and TUV Rheinland. 

"We're very fortunate Anissa has decided to join us," explains Frank O'Brien, President of OBCM.  "With Anissa managing project coordination, our global compliance engineers can dedicate themselves to service fulfillment."

OBCM posts open source forms for Essential Requirement Matrix (Checklist), and combined 2nd & 3rd edition Test Report Form

For details, see Documents page.

OBCM hires new Associate Project Engineer

OBCM announces the hiring of a new Engineering staff member, Christopher Studley.  Chris is responsible for testing, report writing, and generally helping our medical device manufacturing customers with their compliance management tasks.  He has 6 years prior experience working in the R&D departments for a number of Boston based medical device manufacturers.

"We're very pleased Chris has decided to join us," explains Frank O'Brien, President of OBCM.  "With our growing customer base, Chris maintains our ability to deliver responsive, expert service."

IEC, AAMI, and CENELEC publish new electromagnetic compatibility (EMC) standard for medical devices

IEC, AAMI (US version), and CENELEC (European version) have published a new 2007 version of "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests."  The collateral standard is intended to be used with the 3rd edition Part 1, general standard, IEC 60601 1:2005.  It's expected the standard will make it's way onto the EC Official Journal list of harmonized standards, and the FDA list of consensus standards in the next few years, after which time the older standards will no longer allow the presumption of acceptable risk.

The standard clarifies that immunity test levels should be considered a normal use environment, similar to high ambient temperatures. Equipment must "perform satisfactorily" within its intended environment in order to establish electromagnetic compatibility (EMC).  Satisfactory performance is normally a greater level of functionality than only those functions considered essential performance.  On the other hand, the conventional single fault approach to safety is not appropriate for application to EMC standards.

The IEC standard, and its national/regional versions, can be purchased from iec.ch, aami.org, and cenelec.org. For additional information contact Jim Conrad or OBCM.

Jim Conrad, Frank O'Brien help author an EMC Article for Conformity Magazine.

The August 2007 issue of Conformity Magazine has an EMC article, "What's New in EMC Standards for Medical Devices."  For additional information contact Jim Conrad or OBCM.

OBCM offering IEC 60601-1, 2nd & 3rd Edition Training Seminars in Boston or Dublin

Gain practical knowledge you can directly apply to your new medical device designs. Join O'Brien Compliance Management, (OBCM), for 2 days in Boston, USA, in September, or in Dublin, Ireland, in October for practical instruction on designing to new 3rd edition and current 2nd edition medical device safety requirements.  You will earn a certificate upon completion of 16 hours of instruction and exercises.

The instructor is Frank O'Brien, principal engineer of OBCM, and an IEC SC62A member responsible for writing the new 3rd edition. Frank has over 27 years experience working with medical device manufacturers, and over 10 years teaching IEC 60601-1 courses for organizations including IEC, AAMI, and UL.

Explains Frank O'Brien, "This training seminar has been designed from the ground up to emphasize the practical hands on application of new concepts with work group exercises involving typical medical devices.  I want participants to benefit from the hard earned knowledge I gained during the 9 year standard development process. I also hope to interject a bit of fun into the learning process."

For details, see here.

New White Paper posted, "When Should I Design to IEC 60601-1, 3rd Edition?"

A White Paper by OBCM.  IEC 60601-1 is the international basic safety and essential performance standard for electrical medical equipment. The current 2nd edition is IEC 60601-1: 1988 + A1:1991 + A2:1995. In December 2005 a new 3rd edition was published. Many manufacturers are asking, When's the effective date, or transition dates?  When is the required time, and if not required, the optimal time, to start designing to the new edition?   Related to choosing an optimal time, what are the impact of the changes?  This paper examines these questions. There's no simple answer but a practical conclusion is offered.

IEC 62304, Medical Device Software -- Software Life Cycle Processes, Approved and Awaiting Publication

The results of voting by IEC members were published on 21 April.  The standard had 21 yes votes, 5 abstentions, and 0 no votes.  These totals easily met the > 67% in favor and < 25% against thresholds required for adoption, and therefore the 1st edition is on its way to publication; expected on 15 Aug 2006.  It's unclear what jurisdictional authority it will have but its content is effectively a merger of current European and FDA requirements, and therefore it's expected to eventually make it's way onto the EC OJ list of harmonized standards, and the FDA software guidance docs.  For those currently meeting IEC 60601-1-4 and FDA guidance docs, it's more of an evolution of current risk management driven, development life cycle process requirements, rather than an introduction of new concepts.  One concept from FDA docs that has been incorporated is a 3 tier safety classification system (A, B, C), based on the severity of the risk that's being mitigated.  The higher the safety classification, the higher the burden of development life cycle controls.  There are a number of helpful Annexes, including an Annex C, which explains the relationship of IEC 62304 to other standards, like ISO 14971, ISO 13485, IEC 60601-1-4, IEC 61508-3, and ISO 90003.  Once published, the standard can be purchased from www.iec.ch.  OBCM offers services related to safety software development as indicated here.

AAMI Conference on the 3rd Edition of IEC 60601-1

Save these dates in May.  This Conference in Reston, VA, will provide an overview of the new requirements for electrical medical equipment and practical applications.  The speakers are the industry regulatory leaders who wrote the standard, including Frank O'Brien, President of OBCM, who will be moderating the mechanical hazard session.  This is an AAMI Conference that's held annually and is a must-attend event for professionals working in the electrical medical device sector.  The Conference typically has over 300 attendees, including key FDA and other regulatory affairs experts, coming from all over the world.  There's more information at AAMI's website.

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 Laboratory Adds New Test Capability

The OBCM product safety test laboratory has recently added the following new equipment and capabilities:

• Variable voltage, variable frequency power source for 45 to 500 Hz, 85 to 280 V, 2.5 kVA.  This supplements existing 60 Hz, 5 kVA power, and allows 50 Hz temperature testing, and 5x induced potential testing.
• A differential probe, rated for up to 1000 V, 25 MHz.  This allows quick and safe working voltage measurements of switching power supplies, as it allows the scope to be isolated from voltage measurements to non-earthed references.  It will also allow the 1 V surface measurement during defib-proof testing to be done quicker.  This supplements existing probe capabilities of up to 40 kV, 100 A.
• Variable resistive loads for up to 3 outputs, for voltages from 3 to 60 V, and powers from 20 to 1000 W. These supplement an ac resistive load for up to 5 kVA.
• A digital force gauge for push/pull loads from 1 to 250 kg (550 lb).
• A digital torque meter for torques from 6 to 147 Ncm (13 lbin).

By investing in test equipment, OBCM is able to speed up a manufacturer's safety approvals by conducting testing in their laboratory, and where needed, with witnessing by a certification organization, such as UL, ETL, VDE, or TUV.  For more information, see Test Services.

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