IEC/TR 62354, Guidance for Medical Electrical Equipment Testing, Updated

For those of you who use IEC 60601-1 in your business, you know that the IEC/TR 62354, provides you with information on testing for meeting those requirements.  Now the technical report, titled “General testing procedures for medical electrical equipment,” has been updated.  The new 3rd Edition of the publication is available from Document Center now, in paper format or for pdf download.  And it can be included in your multi-user access online subscription service as well.

The IEC/TR 62354 is intended to provide guidance on general testing procedures according to the IEC 60601-1.  So it’s no surprise that it has been updated to align the guidance with the modifications made to the IEC 60601-1 by the Amendment 1 released in 2012.  For this reason, the 3rd Edition of the IEC/TR 62354 is a technical update, withdrawing and replacing the previous 2nd Edition.

What’s new in this revision?  The changes are centered in Section 13, procedures for testing, including particular conditions.

For Clause 13.2, Tests to be performed by inspection, you should particularly review Sections 13.2.1 (risk management), 13.2.4 (durability and legibility of marking), 13.2.5 (battery markings), 13.2.8 (potential equalization terminal) and 13.2.14 (usability of medical electrical equipment).

For Clause 13.3, Measurements and tests performed on non-energized equipment, you’ll need to look at Sections 13.3.1 (humidity preconditioning), 13.3.2 (impedance of PE [protective-earth] connection), 13.3.7 (creepage distances and air clearances), 13.3.12 (instability), 13.3.13 (castors and wheels), 13.3.14 (safety catch evaluation), 13.3.17 (overflow), 13.3.18 (spillage), 13.3.23 (impact), 13.3.24 (drop impact), 13.3.25 (rough handling), 13.3.27 (actuating parts of controls) and 13.3.28 (construction of transformers).

For Clause 13.4, Measurements and tests for equipment that is operating, please review sections 13.4.1 (essential performance – functional), 13.4.3 (voltage mismatch), 13.4.4 (limitation of voltage, current or energy), 13.4.5 (defibrillation-proof applied part protection), 13.4.6 (energy reduction), 13.4.7 (earth leakage current), 13.4.9 (patient leakage current), 13.4.14 (sound pressure level measurements), and 13.4.16 (X-radiation measurement).

You’ll note that some of these sections are new, while others have been revised.

Now to get your copy of this new revision.  Head to Document Center’s webstore at www.document-center.com.  It’s easy to order the publications you need from our collection of over 500, 000 unique titles of specifications and standards from around the world.  Need to talk to an expert before you make your purchase?  Just contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been helping folks like you from our Silicon Valley location since 1982.  Make us your Standards Experts!