Tag: risk management
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.