Medical

OSHA Close to Authorizing NRTL Certification to ANSI/AAMI ES60601-1 for Medical Equipment

by admin on Aug.19, 2014, under Medical, Product Safety

After a long wait, medical electrical equipment manufacturers are looking forward to the Occupational Safety & Health Administration’s (OSHA) expected near-term recognition of one or more labs – including MET Labs – for product safety certifying medical devices to ANSI/AAMI ES60601-1:2005/(R)2012 under the U.S. Nationally Recognized Testing Laboratory (NRTL) Program.

In March 2014, OSHA announced through a Federal Register Final Notice its incorporation of  ANSI/AAMI ES60601-1 into the list of Appropriate NRTL Program Test Standards.  This version of the standard is the U.S. National Version of IEC 60601-1 + A1.

OSHA delayed NRTL recognition for the U.S. version of IEC 60601-1:2005 (3rd edition) due to what it saw as subjective compliance requirements, as well as statements in the standard that would have required the NRTL to accept statements from the manufacturer without the ability for the NRTL to verify the validity of these statements.

The changes in language introduced in Amendment 1 (496 changes for the IEC standard) allows the NRTL to verify the validity of data accepted from the manufacturer.

Here are some of the key changes in AAMI ES60601-1 as compared to UL 60601-1:

  • Clause 9.6 Acoustic Energy – Not included in UL 60601-1
  • Clause 9.7.2-.4 Pressure vessels and parts subject to pneumatic and hydraulic pressure – Not included in UL 60601-1
  • Clause 9.7.6 Pressure control device – Not included in UL 60601-1
  • Clause 9.8 Mechanical hazards associated with support systems – This is a unique mechanical test not included in UL 60601-1
  • Clause 11.2.1 Oxygen Rich Environment – An optional additional test if evaluation is not sufficient for proving that the product is not an ignition hazard in an oxygen-rich environment
  • Clause 15.3.5 Rough handling test – Additional ascending shock testing and door frame shock testing is included that was not present in UL 60601-1
  • Clause 15.4.3.4 Lithium batteries – Not included in UL 60601-1

MET Labs is OSHA-recognized for UL 60601-1, and is expecting to soon be recognized for ANSI/AAMI ES60601-1:2005/(R)2012 as well.  Contact us for a free fast-response quote for electro-medical equipment testing and certification for any major market.

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IEC 60601-1-2 4th Edition for Medical EMC Has Immunity & Risk Management Changes

by admin on May.28, 2014, under EMC, Medical

In February 2014, the IEC published IEC 60601-1-2:2014, ed 4.0 for Medical EMC.  There are a number of changes in the 4th edition, including new immunity and risk analysis requirements. 

Dates
For new products in the U.S., the FDA will make a decision on the 4th edition this July, with a likely 3-year transition period (2017 recognition).  The FDA does not currently require retesting of legacy products unless changes are made to the product that may affect its compliance. 

Canada is planning to review the 4th Edition sometime in 2015 so it will not be accepted before 2015/2016.  It’s typically 3 years before accepted standards are required for new submittals.

In Europe, CENELEC has voted affirmatively to accept the 4th edition but has not set a date to withdrawal (DOW) the 3rd edition.  The DOW of the current 3rd Edition is expected in the 2017-2018 timeframe.  There is no grandfathering in Europe. 

Changes
Following are some of the key changes in the 4th edition.

Use environments are split into three areas:

  • Professional Healthcare Facility Environment
  • Home Healthcare Environment
  • Special Environment (test levels specified in Annex E)

Small clinic, and Home use equipment need CISPR 11 Class B emission, IEC 61000-3-2 Class A harmonic distortion, and IEC 61000-3-3 voltage fluctuation and flicker.  The home use equipment needs 10 V/m, 80 MHz to 1 GHz immunity.

For equipment that is installed in an aircraft or an ambulance, additional testing per ISO 7137 and CISPR 25 applies.

For an EUT with auto ranging power supply, most tests are required to be performed at one nominal voltage only. Only voltage interruptions need to be performed at maximum and minimum voltage if the rated voltage range is >25% of lowest rated input voltage.

Immunity test levels increase:

  • The range of testing for radiated immunity harmonized up to 2.7GHz (up from 2.5GHz in the 3rd edition)
  • Magnetic immunity at 30A/m
  • Conducted immunity at 6V in ISM bands
  • ESD at 8kV contact and 15kV air (up from 6kV and 8kV in the 3rd edition)
  • Voltage dips and interruptions at additional phase angles

In addition to these Immunity changes:

  • Immunity levels (Table 9) are harmonized with IEC 60601-1-11
  • Immunity testing now follows the same port-by-port convention of the IEC 61000-6 series of Generic EMC standards
  • Immunity to proximity fields from RF wireless communications equipment is now included, and is based on a minimum separation distance of 30cm
  • There is a procedure for continuing to test a product that is damaged by an immunity test signal

And Risk Management is expanded:

  • Manufacturers will be required to submit a test plan and the risk analysis document before testing
  • Operating modes are based on risk analysis
  • Reasonably foreseeable electromagnetic disturbances (Annex F) shall be taken into account in the risk management process
  • The risk management process is used to determine whether subsystem testing is allowed
  • The minimum separation distance are considered in the risk management process
  • Reduced test levels (e.g. based on the intended use of the product) must be justified in the risk management file

MET Labs has extensive experience doing EMC testing and product safety testing for medical equipment and scores of other product categories.

Contact us for questions about these changes or for a free quote to test and certify medical equipment to any edition of 60601-1.

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FDA Issues Guidance for Integration of RF Wireless Technology in Medical Devices

by admin on Aug.26, 2013, under EMC, Medical, Wireless

Due to rapid growth in medical devices that incorporate RF wireless technology, on August 14 the Food and Drug Administration (FDA) released final guidance for integrating radio frequency (RF) wireless technology in medical

MET Engineer Doing a Medical Product Evaluation

devices.  The guidance is recommended, but not mandatory.

FDA said its recommendations cover devices that are implanted or worn on the body, and others intended for use in locations such as hospitals and clinical laboratories.

The guidance discusses issues that may affect the safe and effective use of medical devices that incorporate RF wireless technology, including electromagnetic compatibility (EMC).

The use and deployment of RF wireless technology in and around medical devices is an increasing concern because the electromagnetic environments where medical devices are used might contain many sources of RF energy, and the RF wireless emissions from one product or device could potentially affect the function of another, the agency said.

FDA says these issues should be considered for all medical devices that incorporate RF wireless technology, such as Wireless Medical Telemetry Service (WMTS); Medical Device Radiocommunication Service (MedRadio) as well as Medical Micropower Network (MNN) and Medical Body Area Network (MBAN); cellular communication chipsets; and RF identification (RFID) products.

FDA recommends that EMC be an integral part of the development, design, testing, and performance for RF wireless medical devices. Beyond FCC requirements, FDA recommends using risk analysis to identify any potential issues associated with EMC and determining risk acceptability criteria based on information about the device and its intended use, including foreseeable misuse, sources of environmental EMD (e.g., radio transmitters, computer RF wireless equipment), and the potential for RF emissions to affect other devices.

IEC 60601-1-2 is a FDA-recognized consensus standard for EMC, but it does not adequately address whether the wireless communications will operate properly in the presence of in-band EMD (e.g., other RF emissions overlapping the frequency band utilized by the medical device wireless signals). Therefore, the medical device’s wireless communication(s) should be actively transmitting while testing for susceptibility during all EMC immunity testing.

EMC considerations for active implantable medical devices are covered under documents such as the ISO 14708-1 standard (see Appendix B).

FDA worked closely with the Federal Communications Commission (FCC) to develop this guidance.

MET Labs teamed with FDA on a voluntary Program to Test Medical Devices for RFID Interference.  Find out more about the Program. 

MET also tests medical equipment for product safety to 60601-1 3rd edition, for EMC compliance to 60601-1-2, and does performance testing for leading medical device manufacturers.

MET’s Annual Global Compliance Seminar in September will include a session on Electrical Medical Equipment Approvals for EU.  Register here.

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New Medical Equipment Safety of Interoperability Standard AAMI/UL 2800 Being Developed

by admin on Jun.05, 2013, under Medical, Product Safety

This week, MET’s Product Safety Lab Director Rick Cooper is attending a meeting of a newly-convened standards committee in Long Beach, CA to discuss the creation of a new medical equipment safety of interoperability standard(s) tentatively known as AAMI/UL 2800. The meeting is well attended by interested parties consisting of certification agencies like MET Labs, and manufacturers, consultants, researchers, and medical professionals.

The topic is a very complex one, but essentially a need has been determined that medical equipment shall be designed, tested and certified to be interoperable while maintaining a specified level of safety.

The problem of interoperability is significant. There are so many different makes and models of so many different types of products to consider – e.g. pulse oximeters, blood pressure monitors, EKGs, and on and on. Each has its own unique needs and features. For example, with EKG filter settings, how do you assure this is communicated to connected equipment? What protocol is to be used? This is just one example of many possible scenarios.

This initial meeting will move into a standards development process jointly managed by AAMI and UL via UL’s Collaborative Standards Development System (CSDS).

No firm deadline exists for when this process might result in a standard or set of standards, but everyone in attendance agrees it needs to be as soon as possible. Any resulting standard will be voluntary and not mandatory.

Official minutes of the meeting are due to be released to participants in early July.

For more information, contact Rick Cooper at info@metlabs.com with “AAMI/UL 2800” in the subject line.

Register for a free Overview of 60601-1 3rd Edition Webinar for safety certification of electro-medical devices.

For a quote for medical product testing for safety or electromagnetic compatibility, visit our quote center.

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Health Canada Provides Guidance on IEC 60601-1 3rd Edition Transition

by admin on May.07, 2012, under Canada, Medical, Product Safety

For Medical Electrical Equipment product safety compliance in Canada, Health Canada currently recognizes both the second edition of IEC 60601-1, published in 1988, and the third edition, published in 2005. In October, 2008, Health Canada published a notice indicating that until June 1, 2012, conformity to the second edition of IEC 60601-1 and its related collateral and particular standards would be accepted. After June 1, 2012, conformity to the third edition would be required.

New editions of particular standards (specific to a particular device type and designated as IEC 60601-2-X) harmonized with the third edition of IEC 60601-1 have, in many cases, not yet been published, or have been published only recently, making a full transition to the entire family by the June 1, 2012 deadline impossible.

To address this, on March 22, Health Canada issued Additional Guidance on Transition from the Second to the Third Editions of the IEC 60601 Family of Standards on Health Canada’s List of Recognized Standards.  It states:

  • If there is not a particular standard that is directly applicable to the device as of June 1, 2012, it should conform to IEC 60601-1 3rd edition and its applicable collateral standards (that is, IEC 60601-1-X).
  • If there is a particular standard that is directly applicable to the device and the version that harmonizes with IEC 60601-1 3rd edition was published by IEC before June 1, 2009, then the device should conform to IEC 60601-1 3rd edition and its applicable collateral standards in addition to this particular standard.
  • If there is a particular standard that is directly applicable to the device and the version that harmonizes with IEC 60601-1 3rd edition was published by IEC after June 1, 2009, a three year transition period from the date of publication by IEC will apply. During this transition, Health Canada will accept conformity to both editions and related collateral standards.

These transition rules will not be applied retroactively. If the manufacturer currently holds a license for a device that was tested according to IEC 60601-1 2nd edition, you do not need to submit additional data, unless there is a significant change to the product as defined in the Guidance for the Interpretation of Significant Change of a Medical Device.

Keep in mind that provincial or territorial electrical safety requirements are separate and distinct from the requirements of the Health Canada regulations. For further information regarding these requirements, contact the applicable regulatory authorities. A listing of some of these authorities is available here.

The Health Canada website should be consulted for the most current List of Recognized Standards.

For the 3rd edition implementation schedule for the United States, see this Compliance Today post.

Later this month, MET is hosting a free Medical Equipment Regulatory Compliance Seminar in Texas. It features presentations on 60601-1 for product safety and EMC compliance, as well as CE marking.

For testing and certification to the second or third edition of 60601-1, contact MET Labs.

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60601-1 Third Edition Overview Covers Key Changes from Second Edition

by admin on Oct.24, 2011, under Medical, Product Safety

This Compliance Today blog post is derived from the second half of a MET Labs-hosted 60601-1 3rd Edition Overview webinar.  Find the transcription of the first half of the webinar here, or the full recorded webinar here.

Following are the key changes from the 2nd to 3rd edition of 60601-1 for electro-medical device product safety certification.

Risk Management File
The Risk Management File is a new requirement for 3rd edition that goes beyond electric shock, energy and fire hazards.  It requires consideration of all possible risks of use.  The manufacturer must have a policy that addresses risks to include:

  • A declaration of acceptable risks
  • A declaration of acceptance of residual risks

ISO 14971 is essential to a successful Risk Management File. The certification body shall review the Risk Management File and verify that the manufacturer has:

  • Established a suitable process to manage risks of the particular product
  • Established reasonable acceptance levels for these risks
  • Shown that residual risks are acceptable

The Risk Management File must be submitted when a product is submitted to the certification body.

Essential Performance
Essential performance is not new but has been enhanced for third edition.  Many Part 2s have been rewritten with increased performance requirements.  Manufacture must define for their device even if Part 2 does not exist.  Manufactures must address essential performance in the Risk Management File.

Markings & Documentation
Markings must be clearly visible under defined angle, distance and lighting parameters.  Visibility is based on essentially perfect human sight (20/20 in U.S.).

Third edition also has new international symbols or meanings of previous symbols.  There is also increased documentation information.

Usability
Usability is addressed in IEC 60601-1-6.  It covers design, controls, signals, and instructions, and needs to be addressed in the Risk Management File.

Packaging
Transport and storage conditions must be indicated, including any special instructions.  The use of symbols per ISO 780 is mandated.

Insulation Coordination
Changes allow for more compact and less costly designs.  However, they are more complex to interpret.

Hand & Foot Controls
Third edition specifies: 

  • Isolation from hazardous voltages
  • Activation tests
  • Cord anchorage and guard same as mains cord requirement
  • Ingress IPX1 and IPX6

Other Differences
Following are other key difference areas:

  • Stability and mobility tests
  • Noise and vibration tests
  • Temperatures on accessible parts (other than applied parts)
  • Temperatures on applied parts
  • Fire enclosure
  • Mechanical strength
  • Radiation hazards
  • Software
  • EMC

Find out more about product safety testing and certification of electrical medical equipment, or the new Program for Testing Medical Devices for Susceptibility to RFID.

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60601-1 Third Edition Overview Outlines Adoption in U.S., Canada & EU

by admin on Oct.21, 2011, under Medical, Product Safety

Last week, MET Labs hosted a 60601-1 Third Edition Overview webinar.  The webinar was very popular, so we are following up with a transcription of many of the key points.

About half of the presentation was devoted to regional acceptance.

United States
In the U.S., the current standard is UL 60601-1 First Edition, with revisions through April 26, 2006.

  • Based on IEC 60601-1 Second Edition with Amendment 1 and Amendment 2
  • Requires use of Particular Standards or Part 2s
  • Collateral standards are optional

AAMI ES60601-1:2005 incorporates Amendment 2: 2010

  • Based on IEC 60601-1 3rd Edition
  • FDA will accept now as well as previous version
  • FDA has stated they will mandate acceptance by July 1, 2013
  • OSHA has not yet recognized this edition

OSHA, which governs the NRTL program, is concerned with the new concepts of risk-based hazard analysis and the Risk Management File.  It does not yet recognize it nor endorse certification bodies to certify to it.  It may be prudent to consider obtaining current edition and 3rd edition certification.

Canada
In Canada, the current standard is CSA C22.2 601.1-M90 First Edition, revised through November 2003.

  • Based on IEC 60601-1 Second Edition
  • Requires use of Particular Standards or Part 2s
  • Collateral standards are required

Canada also recognizes CSA C22.2 No. 60601-1-08, which is based on the Third Edition.

Switchover date from 2nd edition to 3rd edition is June 2012.

European Union
In Europe, the current standard is EN 60601-1, with amendments through January 1996.

  • Based on IEC 60601-1 Second Edition
  • Requires use of Particular Standards or Part 2s
  • Collateral standards are required

EU also recognizes EN 60601-1, incorporating corrigendum March 2010, which is based on IEC 60601-1 Third Edition.

Switchover date from 2nd edition to 3rd edition is June 2012.

CB Scheme
For the CB Scheme, the current standard is IEC 60601-1 Second Edition, with amendment 1.

  • Requires use of Particular Standards or Part 2s
  • Collateral standards may be required

CB Scheme also recognizes IEC 60601-1 Third Edition.  Participating countries determine which edition they accept.

Stay tuned.  Next week we will cover the other half of the webinar: Key changes in the 3rd edition of 60601-1.

Find out more about product safety testing and certification of electrical medical equipment.

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Medical Product Safety Training Yields Insight on IEC 60601-1 3rd Edition

by admin on Mar.25, 2011, under Medical, Product Safety

MET Laboratories’ product safety engineers undergo regular training to stay up-to-date with changing standards and regulatory requirements.  When possible, we will share highlights of these sessions with customers.

Following are some of the key points of a recent training session on IEC 60601-1 3rd edition:

  • It is an entirely new standard and does not match up with the second edition. The effort required by manufacturers and test labs has at least doubled, or tripled for particularly complex products.
  • Risk Management is an integral part of the new standard. This will catch many manufacturers by surprise.
  • The new standard references ISO 14971, Risk Management, and requires traceability for each identified hazard for the risk analysis, evaluation, implementation and verification of risk control measures and the acceptable risk.
  • The risk management process for applied parts and parts that may contact the patient but that are not applied parts, is particularly onerous.
  • The new standard mandates use of collateral standards in addition to particular, or Part 2, standards. This is likely to catch manufacturers by surprise too.
  • The Risk Management file that a manufacturer must develop has to address the expected service life of the product.
  • The effective date for the EU and Canadian versions is June 2012.
  • The FDA will accept it now but will also continue to accept the previous edition until June 2013.
  • OSHA has not made a decision to recognize the standard yet. They are polling NRTLs as part of their research into this new standard. To meet OSHA workplace rules, medical products may only be certified by an NRTL to the current edition of the UL standard.
  • Though there has been a phase-in period for the main EU standard, collaterals and part 2s are effective upon their publication dates.
  • Some new collaterals are or have been introduced. For example, included now is IEC 60601-1-9, Environmentally Conscious Design.
  • Some previous collaterals, like 60601-1-1 for systems of equipment and 60601-1-4 for EMC, have been incorporated into the base standard now.

See our recent blog post for more information on the various rates of adoption of 60601-1 3rd edition in different countries and regions. 

Also, find out more about EMC and Performance Testing of medical products.

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IEC 60601-1 3rd Edition Challenges Medical Products Industry

by admin on Feb.24, 2011, under Medical, Product Safety

Rarely has a standard change elicited as much confusion – and anguish – as the transition to the third edition of 60601-1. 

Much of the confusion surrounds the varying rates of adoption of the new edition in different countries and regions.  Here is a basic primer: 

IECEE CB Scheme – Issued in 2005, IEC 60601-1 3rd edition is effective now, but so is the 2nd edition, which is still acceptable in many markets.  It’s usually up to the user/buyer/distributor to determine what level of certification he wants.

European Union – EN 60601-1 3rd edition is effective June 1, 2012, but can be used now.  Some part 2 standards may have an earlier adoption date and thus require use of the 3rd edition before June 1, 2012.

Canada – CSA C22.2 NO. 60601-1-08 is effective June 1, 2012, but can be used now.  Health Canada will continue to accept declarations of conformity to the second edition of IEC 60601-1 until June, 2012.  After June, 2012 Health Canada intends to only accept declarations to the third edition of IEC 60601-1, and the related collateral and particular standards.

United States – UL has published AAMI ES 60601-1, Ed. 1.  Acceptance of this standard or the previous edition is up to the user/buyer/distributor.  Though it may be used now it’s not OSHA-recognized yet, so NRTL certification must still be to UL 60601-1 2nd edition.  The FDA does recognize AAMI ES 60601-1: 2005, but will continue to accept declarations of conformity to IEC 60601 2nd edition until June 30, 2013.

The anguish surrounding the third edition is attributable to the much stiffer requirements of the standard.  Most significantly, the 3rd edition requires that the manufacturer establish a risk management file and process as outlined in ISO 14971, the international standard for Application of Risk Management to Medical Devices.

Because of these new requirements, third edition certification projects are typically double to triple the duration and cost of their second edition equivalent.

More on medical product certification to IEC 60601-1.

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