Regulatory Information; Medical Equipment Safety Standards - Konica Minolta SKR 4000 User Manual

5. Regulatory Information

5.1. Medical equipment safety standards

Medical equipment classification
Type of protection against electrical shock
Degree of protection against electrical shock
Degree of protection against ingress of water
Mode of operation
Flammable anesthetics
Product safety standards
MDD (93/42/EEC)
ISO 13485:2016
IEC 60601-1:2005/AMD1:2012
IEC 60601-1-2:2014/EN60601-
1-2:2015
IEC 60601-2-54:2015/EN
60601-2-54:2015
IEC 62133:2012
IEC 62220-1:2003
EN 62220-1:2004
IEC 62304:2006/AMD1:2015
IEC 62366-1:2015/IEC
62366:2007/EN 62366:2008
IEC 60601-1-6:2010+A1:2013
EN ISO14971: 2012
ANSI/AAMI
1:2005/(R)2012+A1:2012+C1:2
INC..................................................................................................................................
External electrical power source equipment Class I
Equipment (medical approved adaptor)
Internal electrical power source equipment (battery)
Type-B applied part
IPX1
Continuous operation
Not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous
oxide
Not suitable for use in the oxygen rich environment
Medical Device Directive
Medical devices
Requirements for regulatory purposes
Medical electrical equipment -- Part 1: General requirements
for basic safety and essential performance
Medical electrical equipment – Part 1-2: General requirements
for basic safety and essential performance – Collateral
standard: Electromagnetic disturbances – Requirements and
tests
Medical electrical equipment -- Part 2-54: Particular
requirements for the basic safety and essential performance of
X ray equipment for radiography and radioscopy
Secondary cells and batteries containing alkaline or other non-
acid electrolytes – Safety requirements for portable sealed
secondary cells, and for batteries made from them, for use in
portable applications
Medical electrical equipment - Characteristics of digital X-ray
imaging devices - Part 1: Determination of the detective
quantum efficiency
Medical device software - Software life-cycle processes
Medical devices –part 1: Application of usability engineering
to medical devices
Medical electrical equipment - Part 1-6: General requirements
for basic safety and essential performance - Collateral standard:
Usability
Medical device – Application of risk management to medical
devices
ES60601- Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance (IEC 60601-1:2005,
Regulatory Information
-- Quality management
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