Safety and Regulatory Information
AJ4309 | 2019-08-13 1–17
Standards
ISO 13485:2016 Medical devices — Quality management systems —
Requirements for regulatory purposes
IEC 60601-1:2005/AMD1:2012 Medical electrical equipment — Part 1: General
requirements for basic safety and essential perfor-
mance
IEC 60601-1-2:2014/EN60601-1-2:2015 Medical electrical equipment — Part 1-2: General
requirements for basic safety and essential perfor-
mance — Collateral standard: Electromagnetic dis-
turbances v Requirements and tests
IEC 60601-2-54:2018/EN 60601-2-54:2019 Medical electrical equipment — Part 2-54: Particu-
lar requirements for the basic safety and essential
performance of X ray equipment for radiography
and radioscopy
IEC 62133-2:2017 Secondary cells and batteries containing alkaline or
other non-acid electrolytes — Safety requirements
for portable sealed secondary lithium cells, and for
batteries made from them, for use in portable
applications — Part 2: Lithium systems
IEC 62220-1-1:2015/EN 62220-1-1:2015 Medical electrical equipment — Characteristics of
digital X-ray imaging devices — Part 1-1: Determi-
nation of the detective quantum efficiency - Detec-
tors used in radiographic imaging
IEC 62304:2006/AMD1:2015 Medical device software — Software life-cycle pro-
cesses
IEC 62366-1:2015/IEC 62366:2007/EN62366:2008 Medical devices — Part 1: Application of usability
engineering to medical devices
IEC 60601-1-6:2010+A1:2013 Medical electrical equipment — Part 1-6: General
requirements for basic safety and essential perfor-
mance — Collateral standard: Usability
EN ISO14971:2012 Medical device — Application of risk management
to medical devices
ANSI/AAMI
ES60601-1:2005/(R)2012+A1:2012+C1:2009/(R)2
012+A2:2010/(R)2012
Medical electrical equipment — Part 1: General
requirements for basic safety and essential perfor-
mance (IEC 60601-1:2005, MOD)
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