What's New

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.

News Archive