The International Electrotechnical Commission (IEC) has released a new edition of the standard for “Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment.” IEC 60601-2-50:2009+AMD1:2016 CSV (consolidated version) can now be purchased at the IEC webstore.
This second edition replaces the first edition that published in 2000. Specific technical changes from the previous edition include: requiring graphical representation of the spectral irradiance in the instructions for use (this was previously optional; see 201.7.9.2.5 b)); requirements for support and mounting brackets for ACCESSORIES (see 201.9.8.101); requiring restoration of any preset values upon interruption and restoration of the power supply, if applicable (see 201.11.8); and corrections to the first four exposure limits (ELs) listed in Table AA.1.
Description*
IEC 60601-2-50:2009+A1:2016 establishes particular basic safety and essential performance requirements for infant phototherapy equipment, which reduce the safety hazards to patients and operators as much as possible, and specifies tests for demonstrating compliance with these requirements. This second edition cancels and replaces the first edition published in 2000. This edition constitutes a technical revision. The main purpose of this new edition is to provide consistency with the third edition of the general standard. This edition further provides consistency with the four other particular standards related to pediatric equipment for which the committee is responsible. The contents of the corrigendum of August 2010 have been included in this copy. This consolidated version consists of the second edition (2009) and its amendment 1 (2016). Therefore, no need to order amendment in addition to this publication.
*Description from the IEC’s website.
