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.