IEC 60601 - 1 3rd Edition
IEC 60601 - 1 3rd Edition Standard Testing
IEC 60601 - 1 is the harmonised standard for medical electrical equipment recognised by public health authorities in most countries around the world. First published in 1977 IEC 60601 - 1 has become the gold standard of medical electrical equipment safety and the parent standard of over 60 particular device standards. With its increased emphasis on Risk Management the 3rd Edition of IEC 60601 - 1, first published in 2005 and presently being adopted by countries and public health organisations around the world, represents a major overhaul of the IEC 60601 family of medical electrical equipment safety standards.
Transition Dates for IEC 60601 - 1 3rd Edition
|
EU General Standard |
June 1, 2012 |
|
EU Particular Standard |
Varies* |
|
Canada |
June 1, 2012 |
|
USA (FDA) |
July 1, 2013 |
|
Brazil |
January 1, 2014 |
|
Japan, China |
TBD |
* Medical devices that fall within the scope of a particular standard are subject to various dates as noted by the Official Journal of the EU. Contact Anecto for specific and current dates.
Why is this transition so important?
The 3rd Edition of IEC 60601 - 1 represents a departure from the 2nd Edition in that it is now a requirement for all manufacturers of medical electrical equipment and systems to have a formal risk management system in place to comply with the new standards.
What is the formal Risk Management Process?
Risk management is now a key element of the 3rd Edition. On top of the requirement for manufacturers to establish a risk management process that conforms to ISO 14971 (the only international standard for risk management for medical devices) there are more than 100 instances where the standard directs manufacturers to determine risk acceptability in applying a particular requirement. For each of these instances the manufacturer must assess the risk of its device and act according to how that risk compares to its predefined levels of risk acceptability.
The addition of the Risk Management Process now allows the manufacturer greater freedom. The introduction of the standard states that, 'In all cases, the risk management process will determine whether the requirements of the standard are appropriate and acceptable'. This simply means that manufacturers are now free to target certain areas of the standard that are directly applicable to their product. However, if they choose to ignore other areas of the standard that they feel are not relevant to their product, they must clearly outline their reasons for doing so in the Risk Management File.
As mentioned above, in order to claim conformity to the 3rd Edition a manufacturer must impose a Risk Management Process where the requirements of ISO 14971 are satisfied. The requirement of this clause and all requirements of this standard referring to inspection of the Risk Management are considered to be satisfied if the manufacturer has:
- Established a Risk Management process;
- Established acceptable levels of risk; and
- Demonstrated that the residual risk(s) is acceptable in accordance with the policy for determining acceptable risk.
There are numerous reasons for the increased emphasis on Risk Management in the third edition. The strict imposition of Risk Management allows the third edition to keep up with ever evolving technology. Applying a Risk Management process enables a manufacturer to capitalise on advancements in technology while providing safer products.
It is also recognised that explicit use of Risk Management is an efficient way to address essential safety performance issues in a way that would be impossible with a standard utilising only rigid test methods and pass/fail criteria. It is important to stress that the Risk Management Process must address the entire life-cycle of the device, not just the design.
How does this impact your Company?
Once established, risk acceptability levels are key to the application of the third edition. A range of decisions are made based upon comparing residual risks with predefined risk acceptability levels. In order to make these decisions the levels of risk being assessed have to be quantified.
In demonstrating that a residual risk is acceptable it must be shown to be less than or equal to an acceptable level of risk. Such a comparison is extremely difficult to make if risks are not measurable in some way and many manufacturers may find this adjustment difficult. If a manufacturer cannot adequately quantify the risks it may have difficulty demonstrating to a certification body or regulatory committee that the residual risk is acceptable. Anecto can offer the expertise to aid your company in making the necessary adjustments to conform to the 3rd Edition.
What can Anecto offer you?
Anecto has the experience and expertise to help ensure your product is IEC 60601 - 1 compliant. We accomplish this by developing a Risk Management File that we review throughout the development cycle of your product. Once we have evaluated all the judgements in your Risk Management File we can validate it in accordance with ISO 14971. Anecto also has the capacity to ensure compliance to IEC 60601 - 1 3rd Edition for products that have already been certified to the 2nd Edition.
When you choose Anecto for IEC 60601 - 1 compliance you receive:
- A dedicated service and advice from trusted experts.
- An unbiased evaluation of your Rick Management Process which allows you to track your progress in conforming to IEC 60601 - 1 3rd Edition and ensures the safety of your product according to the recognised standard.
