Tag: risk management
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.
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.
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
Contact us for questions about these changes or for a free quote to test and certify medical equipment to any edition of 60601-1.
The 2012 International Consumer Product Health and Safety Organization (ICPHSO) Annual Meeting and Training Symposium in Orlando moved into Workshop Day yesterday.
Some of the topics that were addressed:
- Global regulatory outlook
- Comparing Canadian and U.S. Consumer Product Safety Law
- EU Directives related to toys
- Effective recalls
- Risk management
- Global product safety strategies
- Hazardous substance regulations
The most interesting workshop looked at what product safety agencies will be focused on in 2012.
The U.S. market was covered by Kenneth Hinson, Executive Director of the U.S. Consumer Product Safety Commission. Following are staff-proposed 2012 priorities, although he emphasized that they have not yet been approved by the Commission.
Import surveillance. Expand Risk Assessment Methodology (RAM) pilot.
Global outreach to regulated community. Build capacity of regulators in producer nations. Lead standards harmonization efforts. Continue operations of Beijing office.
Market surveillance and enforcement.
IT modernization to bridge silos. CPSRMS (Consumer Product Safety Risk Management System) and ITDS RAM.
Key mandatory standards activities. Table saws, portable generators, durable nursery products, etc.
Connecting with consumers. NSN and CPCS 2.0 Social Media Initiative.
Work on potential testing and certification revisions. Opportunity to reduce 3rd party testing burden (P.L. 112-28). Small batch manufacturing exemption. ATV final rule.
A side note. The next ICPHSO meeting will be in Brussels, Belgium October 16-17, 2012. In 2013, there will be meetings in Arlington, Virginia and on the Gold Coast of Australia. Spain will host a 2014 meeting, followed by plans to return to Japan and China. ICPHSO organizers were encouraged by a successful Asia-Pacific Consumer Product Safety Symposium in Seoul, Korea in 2011.
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 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 is addressed in IEC 60601-1-6. It covers design, controls, signals, and instructions, and needs to be addressed in the Risk Management File.
Transport and storage conditions must be indicated, including any special instructions. The use of symbols per ISO 780 is mandated.
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
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
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.
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.
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.