| IEC 60601-2-50 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)] |
| Recognition Date | 2017-08-21 |
| Recognition List | 047 |
| Recognition Number | 6-387 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Sajjad Syed FDA/OMPT/CDRH/ODE/DAGID/ANDB/ 301-796-6295 sajjad.syed@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.5700 | Unit, Neonatal Phototherapy | Class 2 | LBI |
| There is no relevant guidance developed at this time. |