What's New

Frank retiring

posted Oct 31, 2017, 8:26 AM by Frank O'Brien

Frank O'Brien, our founder, will be retiring from active consulting and testing starting in Jan 2018. The company will remain a provider of IEC 60601 training services. Frank will also stay active with IEC 60601 committee work through 2019. After 2019, Frank and OBCM will be winding down to full retirement.

We're finishing the work we have now. We're not taking on any new work.  

We can recommend the following Consultants/Labs that could help you out.

MECA
Located in Wisconsin
Brian Biersach (sales and engineering)
(262) 347-3436
www.mecassociates.us
Accreditations

Eisner Safety Consultants
located in Portland OR
Leonard (Leo) Eisner, P.E.
Principal Consultant
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

TUV Rheinland
Littleton MA
Richard Kilroy (sales)
Greg Chase (Engineering)
978-266-9500 ex 4225
rkilroy@us.tuv.com
Accreditations

Interek
Boxboro MA
http://www.intertek.com
978-263-2662
Rayshon Payne (Sales)
Bill Sterns (Engineering)
Accreditations

Curtis Straus a BV company
Littleton MA
Anissa Herrick (Sales)
Steve Henderson (Engineering)
978-486-8880
anissa.herrick@us.bureauveritas.com
Accreditations

We have a full list of test and consulting service providers here.

We may sell our test equipment and a portion of our business to a local new business.  We'll keep you informed should that occur.  This will be a good option for consulting and test services as well.

What's New for Medical EMC?

posted Sep 12, 2017, 10:48 AM by Debra Carlson   [ updated Sep 12, 2017, 12:02 PM ]

Amendment underway to the Electromagnetic Disturbances standard

Early 2017, work began on Amendment 1 to IEC 60601-1-2:2014, edition 4.0, the medical electrical equipment collateral standard for electromagnetic disturbances.  With Amendment 1, the edition will become 4.1 and target publication date will be late 2019.

 The "Short List" items for the electromagnetic disturbances standard are summarized below:

·        Perform conducted and radiated emissions testing using multiple AC input voltages

·        Clarification of voltage dips and Interrupts to with respect to the min./max voltage rating

·        Delete the exemption for testing short SIP/SOP cables for conducted immunity testing

·        Consider the use of IEC 61000-4-39 for Close Field Proximity testing

·        Clarify the emissions requirements for devices used on aircraft

·        Simplify Annex E (Special Environments)

·        Simplify Annex F (Risk Management)

·        Add a low frequency (<150 kHz) magnetic Immunity test requirement

·        Update references to CISPR standards

·        Correct an error for the voltage dips and interrupts testing (Table 5 note r) as it contradicts similar note in Table 1


The Kobe agreement (Nov 2015) and voting in Frankfurt (Oct 2016) by the TC62 National Committees established a “Short List” of safety critical issues, which will be addressed in the next amendments to the IEC 60601 general standard and all of the collateral standards.

Darryl Ray a member of IEC TC 62, SC 62A Maintenance Team 23, the committee responsible for this work, can be contacted for further questions. 

Darryl, together with OBCM, is offering along with Safety Training an EMC Training Seminar in Boston, November 2017.  

For more details click here.

New 2017 Training Schedule

posted Feb 2, 2017, 9:06 AM by Debra Carlson   [ updated Sep 14, 2017, 8:43 AM ]

Our Training for Integrating medical device safety into the design process

IEC 60601/ISO 80601, ed 3.1 and 2.2 families will be held in 3 locations this year

May 23-25
Sept 12-14 
Nov 7-9

Thanks for coming....

posted Oct 27, 2016, 1:00 PM by Debra Carlson

Thanks to everyone who came out to our open house always a nice time and a little info/education as well. For those of you who missed it here is Franks presentation

what's new, shocktober 2016

 

OBCM Open House

posted Sep 29, 2016, 9:05 AM by Debra Carlson

Shocktober 
Wednesday October 19, 2016
5pm to 8pm

We cordially invite you to join us for our annual Open House

  • Frank O'Brien will give a brief talk on regulatory changes in 2016
  • We will have Lab demos  
  • There will be plenty of food and drinks at Apriles Restaurant's upstairs Bar (located in the same building as us)  
  • Also, giveaways so make sure to bring your business cards. 

EM Safety; EU and FDA effective dates

posted Aug 3, 2016, 10:46 AM by Frank O'Brien   [ updated Aug 3, 2016, 11:34 AM ]

The FDA recently extended the effective date for the EM Disturbances collateral, IEC 60601-1-2:2014, 4th edition, to align the date with the recently announced EU harmonized standard date. Here’s a summary of upcoming FDA and EU effective dates.

Medical Electrical Equipment Standard

FDA effective date

EU effective date (DOCOPOCOSS)

Electromagnetic Disturbance, IEC 60601-1-2:2014 (ed 4)

31 Dec 2018


Announced 5 Jul 2016, extended from 1 Apr 2017,

31 Dec 2018, (EN 60601-1-2:2015)


Announced 13 May 2016


The scope of IEC 60601-1-2:2014, is safety, i.e. freedom from unacceptable risk.  During immunity testing, the medical electrical equipment under test must maintain basis safety and essential performance.  In some cases immunity levels are higher than currently specified in IEC 60601-1-2:2007.

The impact of transitioning

For a summary of the newer requirements in IEC 60601-1-2:2014, where new testing may be needed, see our prior news post here.

How Effective Dates Work

With FDA effective dates, these apply when seeking device clearance (510(k) or approval (PMA)). They don’t apply for products already cleared/approved for US market.

With EU effective dates, these apply to all products placed on EU market after date.

EM Compatibility

There's also a technical report, IEC TR 60601-4-2:2016, Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems. The scope of this technical report is EM compatibility. During immunity testing, the medical electrical equipment under test must maintain intended functionality. Immunity levels are a bit less than safety immunity levels. This technical report describes how to meet both EMC and EM Safety (IEC 60601-1-2) in one set of tests.

Other safety standard effective dates

For other related effective dates, see our prior news post here.

FDA EMC guidance

In a future post we'll describe FDA's 11 July 2016 EMC guidance document for manufactures seeking device approval.

A FAQ for medical equipment with intentional radios

posted May 31, 2016, 9:19 AM by Frank O'Brien

Some terms:


Term

Meaning

Intentional radio

radio transmitter such as for WiFI, Bluetooth, RFID, cell phones

R&TTED

Radio and Telecommunication Terminal Equipment Directive, 1999/5/EC

RED

Radio Equipment Directive,  2014/53/EU

MDD

Medical Device Directive, 93/42/EEC


Harmonized standards for RED and R&TTED, http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/rtte/index_en.htm


Q1. What’s the effective date for RED?


A1: On 13 Jun 2017, all electrical medical equipment with intentional radios placed on EU market will need to comply with RED, (except radios that fall within the exceptions listed in Annex I: amateur, marine, airborne, R&D).  The R&TTED will be no longer valid.


Q2: Can a new electrical medical device with an intentional radio be placed on the market in compliance with R&TTED up until 13 Jun 2017?


A2: Yes.  It probably wasn’t the intention for new equipment, as the R&TTE is repealed on 13 Jun 2016, but the period between 13 Jun 2016 and the 13 Jun 2017 effective date for the RED is being treated as a transition period for new and legacy equipment being placed on market.


Q3: Does RED take full responsibility for the medical device?


A3: No, the medical device will still need to comply with the MDD and its harmonized standards, including the safety standard series EN/IEC 60601/ISO 80601, its EMC collateral, EN/IEC 60601-1-2, and the reference standards to which the collateral refers, including, series EN/IEC 61000-x-x.


The radio portion will need to comply with the RED and its harmonized standards, including  EN 300 328-x and the EN 301 489-x standards.


Q4: What’s listed on the Declaration of Conformity (DoC)?


A4: The DoC must declare conformity to both the MDD, and RED.  The MDD DoC does not require harmonized standards be listed on the DoC (rather these are in technical file).  Article 18, and Annex VI of RED requires that the “harmonized standards, or other technical specifications” be part of DoC.


Q5: Has an analysis been done to summarize the worst case radio/EMC standards to which medical devices with intentional radios need to comply?


A5: No.  An analysis will need to be done on a case by case basis.  In the case of a radio module certified and tested, all the work with respect to the RED directive has been already done. The compatibility of the module with the medical part is then evaluated with the safety tests, EMC tests, etc. for the whole combination, for example by application of the EMC standards listed as harmonized standards under the MDD.


Q6: Can OBCM help with further questions?


A6: Yes.


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Regulatory Safety Consulting and Testing Services

At OBCM we help medical device manufacturers speed up their regulatory and safety approvals

Each year, our 3 day IEC 60601-1, ed 3.1 training course is offered in the US on the east and west coasts; and in Europe. The course continues to evolve to stay up to date with the latest standards, interpretations, regulatory guidance, and feedback from over 1,100 past participants.

Keeping up with the effective dates

posted May 11, 2016, 1:59 AM by Frank O'Brien   [ updated Jul 6, 2016, 9:10 AM ]

FDA and EU effective dates

Here’s a summary of upcoming FDA and EU effective dates for common Medical Electrical Equipment safety standards

Medical Electrical Equipment Standard

FDA effective date

EU effective date (DOCOPOCOSS)

Amendment 1:2012 to General Basic Safety and Essential Performance, IEC 60601-1:2005, ed 3.1

1 Aug 2016

31 Dec 2017

Electromagnetic Disturbance, IEC 60601-1-2:2014 (ed 4)

31 Dec 2018 (recently extended from 1 Apr 2017, announced 5 Jul 2016)

31 Dec 2018 (announced 13 May 2016)

Home health care, IEC 60601-1-11:2015 (ed 2)

1 Apr 2017

Not announced, 2017-2018 expected

Amendment 1:2015 to Software, IEC 62304-1:2006, ed 1.1

since 4 Apr 2016

Not announced, 2019 expected

Usability engineering, IEC 62366-1:2015

since 14 Aug 2015

Not announced, 2018 expected

Emergency medical services, IEC 60601-1-12:2014 (ed 1)

since 14 Aug 2014

Not announced, 2017-2018 expected


With FDA effective dates, these apply when seeking device clearance (510(k) or approval (PMA). They don’t apply for products already cleared/approved for US market.

With EU effective dates, these apply to all products placed on EU market after date. EU effective dates seem to be held up awaiting Annex Z to the EN standards (mapping to directive essential requirements). Consistent with maintaining state of the art it’s acceptable to use the newer (non-harmonized) standards to presume compliance with essential requirements, but you should confirm with your notified body. 


Impact of Amendment 1, IEC 60601-1, ed 3.1 

Amendment 1 to the general basic safety and essential performance safety standard for medical electrical equipment is required for new FDA submittals after 1 Aug 2016. Amendment 1 mostly makes the application of the base standards easier/clearer. For example, risk management records has been reduced, Y-capacitors in secondary circuits is clarified, and rough handling requirements for mobile equipment are reduced. New more stringent requirements, which would normally be applied anyway based on risk assessment, are 

  • lithium batteries are required to comply with IEC 62133, and 
  • software must comply with IEC 62304, in addition to existing clause 14.
  • when seeking CB cert, OD-2055, requires usability engineering to IEC 60601-1-6 and IEC 62366 to be within scope
  • NRTL/Can certifications remain valid without Amendment 1.

To demonstrate compliance to the new amendment, you’ll need new verification documents.

Impact of IEC 62366-1

The newer Usability Engineering standard is also required by FDA. There’s no fundamental changes, but things rather the process description evolves:
  • Human Factors Engineering is a synonym for Usability Engineering
  • Use Error Causes -- Perception, Cognition, or Action; compared with categories; Unintended Slip or Lapse, and Intended Mistake
  • Hazard Related Use Scenarios; identify, describe, categorize 
  • Evaluation types -- Formative (iterative), Summative (final); compare with verification (serial phases) and validation (final)
  • NRTL/Can certifications remain valid without IEC 62366-1

To demonstrate compliance to the new standard, you’ll need new verification documents.

Risk reduced As Far As Possible

As a reminder, the guidance document to help with the application of Annex ZA to the EU Risk Management Standard is available here, NBs Recommendation Group’s "Interim" Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971: 2012, Version 1.1, 13 October 2014. OBCM has a blog post with more information here, more information.

= o =

Regulatory Safety Consulting and Testing Services

At OBCM we help medical device manufacturers speed up their regulatory and safety approvals

Each year, our 3 day IEC 60601-1, ed 3.1 training course is offered in the US on the east and west coasts; and in Europe. The course continues to evolve to stay up to date with the latest standards, interpretations, regulatory guidance, and feedback from over 1,100 past participants.

IEC/SC 62A CAG meeting, Daytona Florida

posted Feb 18, 2016, 10:46 AM by Debra Carlson   [ updated Apr 11, 2016, 4:40 AM by Frank O'Brien ]

The upcoming IEC/SC 62A CAG meeting being held in Daytona Florida this February, which Frank O'Brien will be attending, will be to propose a prioritzed "short list" of changes to IEC 60601-1 and its collaterals that might be included in an Amendment 2, or if all candidates for changes will be held until work begins on an Edition 4.  This work was authorized during the November 2015 Kobe meeting.

After, the short list items will be circulated to the National Committees at the Frankfurt meeting in October 2016. There will be a vote on whether to begin work on Amendment 2 with the short list, or postpone work until Edition 4.

2016 Training Schedule

posted Feb 1, 2016, 12:23 PM by Debra Carlson   [ updated May 24, 2016, 10:15 AM ]

 London England COMPLETED There are 3 more opportunities this year!


Click here for Registration and more information 


 

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