IEC 60601-1-2:2014 (4th Edition)
IEC 60601-1-2:2014 (Edition 4) has been recently published by the IEC. The date of publication (DOP) for the European version (EN 60601-1-2) is January 1, 2015. The technical content of the IEC version is identical to the EN version.
The 4th edition is significantly different than its predecessor. Some highlights of the differences are;
The 4th edition is significantly different than its predecessor. Some highlights of the differences are;
- EMC must be addressed in the Risk Management documentation
- A test plan is required
- The requirements of CISPR 15 have been eliminated
- Requirements of CISPR 14 clarified
- Immunity acceptance criteria is based on Essential Performance and Basic Safety only
- Immunity levels are based on the intended use locations
- Radiated Immunity upper test frequency has been extended. Modulations modified
- Increased ESD test levels
- The ESD test method on connectors is modified
- New test: "Close Field Proximity" - Radiated Immunity specific frequencies, up to 28 V/m, modified modulations
- New Surge test for devices connected to 12V vehicle power
- Conducted Immunity levels are increased in some cases
- Voltage Dips & Interrupts testing adds additional phase angles
- AC input voltage requirements for all tests are clarified
- Connection of the Potential Equalization Conductor Terminal is addressed
- A new procedure has been added to establish a procedure if a device is damaged during immunity testing
- Magnetic Immunity test levels are significantly increased
- A test report is required with the minimum contents are specified
- Modified labeling requirements
- and more…
This new standard may have a significant impact to the design, testing and documentation to many medical devices.
Impact on Legacy Devices
For legacy devices, some of the previous data gathered for example emissions test data may be suitable to apply to the 4th edition. Much of the immunity test data however is likely to be invalid as the pass fail criteria may have changed as linked to Essential Performance. The documentations requirements also will need updating.
If I meet the 4th Edition, can I claim compliance with a previous version of IEC 60601-1-2?
Although the 4th edition is more stringent in a number of areas, it is not worse case in all aspects. It would be incorrect to assume compliance with the 4th edition would also constitute compliance with the third edition (or earlier) as there are a number of differences between the two documents. A apples to apples comparison cannot be fully made.
Need Help with Essential Performance?
What exactly is Essential Performance and how do I determine it for my product? Essential Performance is defined from as many as three sources;
When do we have to comply with IEC 60601-1-2 4th edition?
The required date for compliance can be difficult to determine as the global requirements are not synchronized. The mandatory global compliance dates depends on the specific device type, its production status and region the product is marketed. A brief summary categorized by region is shown below:
US - For new submittals, compliance to the 4th edition is now mandatory as of January 1, 2019.
European Union - The Date of Withdraw (DOW) which is the required compliance date of EN 60601-1-2:2015, ended December 31, 2018. All medical devices shipped into the EU must meet EN 60601-1-2:2015.
Other Regions - The compliance dates are highly variable as they are driven by other international standards and local regulations. For example, the particular standard (IEC 80601-2-X) for a given device may have an undated reference to IEC 60601-1-2. In this case, compliance to IEC 60601-1-2 4th edition would be linked to the compliance date of the particular standard with no grandfathering provisions. Additionally, some countries will NOT accept the 4th edition at this time to further complicate this issue. We can help in the determination the mandatory compliance date on IEC 60601-1-2, 4th Edition for your device.
Please Note: The compliance dates of standards are driven by international regulators and are subject to change.
Impact on Legacy Devices
For legacy devices, some of the previous data gathered for example emissions test data may be suitable to apply to the 4th edition. Much of the immunity test data however is likely to be invalid as the pass fail criteria may have changed as linked to Essential Performance. The documentations requirements also will need updating.
If I meet the 4th Edition, can I claim compliance with a previous version of IEC 60601-1-2?
Although the 4th edition is more stringent in a number of areas, it is not worse case in all aspects. It would be incorrect to assume compliance with the 4th edition would also constitute compliance with the third edition (or earlier) as there are a number of differences between the two documents. A apples to apples comparison cannot be fully made.
Need Help with Essential Performance?
What exactly is Essential Performance and how do I determine it for my product? Essential Performance is defined from as many as three sources;
- Per IEC 60601-1, Edition 3.1
- Per the relevant IEC 80601-2-X particular standard (if applicable)
- By the manufacturer as determined by the Risk Analysis assessment
When do we have to comply with IEC 60601-1-2 4th edition?
The required date for compliance can be difficult to determine as the global requirements are not synchronized. The mandatory global compliance dates depends on the specific device type, its production status and region the product is marketed. A brief summary categorized by region is shown below:
US - For new submittals, compliance to the 4th edition is now mandatory as of January 1, 2019.
European Union - The Date of Withdraw (DOW) which is the required compliance date of EN 60601-1-2:2015, ended December 31, 2018. All medical devices shipped into the EU must meet EN 60601-1-2:2015.
Other Regions - The compliance dates are highly variable as they are driven by other international standards and local regulations. For example, the particular standard (IEC 80601-2-X) for a given device may have an undated reference to IEC 60601-1-2. In this case, compliance to IEC 60601-1-2 4th edition would be linked to the compliance date of the particular standard with no grandfathering provisions. Additionally, some countries will NOT accept the 4th edition at this time to further complicate this issue. We can help in the determination the mandatory compliance date on IEC 60601-1-2, 4th Edition for your device.
Please Note: The compliance dates of standards are driven by international regulators and are subject to change.
Darryl Ray EMC Consulting, LLC darryl.ray@dray-emc.com 925-487-0072