A new 4th Edition has just been released for IEC 60601-1-2, “Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.” The new revision replaces the 3rd Edition, which is now obsolete. This particular document is geared for medical equipment that will operate in healthcare facilities or in the home. It confirms that the equipment will not affect or be affected by other devices in the area. For example, it is concerned with the interference with RF wireless communications equipment that is becoming more commonplace in these types of locations.
The standard is a complementary document to the IEC 60601-1, “Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.” The set of IEC 60601-1 collateral standards each address a particular situation or equipment that is not addressed in the main document.
In the new 4th Edition for IEC 60601-1-2, there are a series of updates and additions. They include:
- Harmonization of the locations for intended use with the IEC 60601-1-11, Professional healthcare facilities, home healthcare and special environments.
- Changes in the tests and test levels when portable RF communications equipment is used closer to the medical electrical equipment than was specified in the 3rd edition,
- Use of tests based on the ports of the equipment or system,
- The increase of immunity test levels in some cases based on the expected reasonable maximum level of disturbance in the environments of intended use,
- Better harmonization with the concept of risk, including the deletion of the term “life-supporting,”
- New guidance on determining immunity test levels for special environments,
- Guidance of how to adjust test levels when special considerations are applicable,
- New guidance on risk management for electromagnetic disturbances, and
- Information on the pass/fail criteria for identification of immunity.
IEC 60601-1 and it’s collateral standards play an important role in the safety of medical electrical equipment development and production. If this is a part of your product safety criteria, you’ll want to purchase a copy of the new 4th Edition.
You can get your copy in paper format or as a pdf download from the Document Center webstore at www.document-center.com. Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We have been providing customers with access to standards since 1982. Make us your Standards Experts!
P.S. You may also need the new Corrigendum 1 for the IEC 60601-2-2, 5th Edition, titled “Medical Electrical Equipment – Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories.” This Technical Corrigendum is a correction sheet, 1 page in length.
