Maico easyTone - Electrical Safety, EMC and Associated Standards

Operation Manual easyTone
8529689 Rev. 2
61
10/05/2022
6.5 Electrical Safety, EMC and Associated Standards
• IEC 60601-1: 2005 + Corr. 1:2006 + Corr. 2:2007 + AM1:2012/ ANSI/AAMI ES60601-
1:2005 + A2:2010/ CAN/CSA-C22.2 No. 60601-1:14: Medical Electrical Equipment,
Part 1 General Requirements for Basic Safety and Essential Performance
• IEC/EN 60601-1-2: 2015 + AMD1:2020: Medical Electrical Equipment - Part 1-2:
General Requirements for Basic Safety and Essential Performance - Collateral
Standard: Electromagnetic Compatibility - Requirements and tests
• ISO 14971:2019- Application of risk management to medical devices
• General Safety and Performance Requirements of the current REGULATION (EU)
2017/745
• 2011/65/EU of 8 June 2011 on the restriction of the use of certain hazardous
substances in electrical and electronic equipment (RoHS)
• Directive 2002/96/EC of the European Parliament and of the Council of
27 January 2003 on waste electrical and electronic equipment (WEEE)