Medisafe PCF Pro - Applied Standards

PCF Pro User Manual
DOC01851 Page 64 of 74
Applied Standards
Standard Description
2006/42/EC Machinery Directive
ISO 13849-1:2006
Safety of machinery - Safety-related parts of control systems -- Part
1: General principles for design
ISO 13849-1:2012
Safety of machinery - Safety-related parts of control systems -- Part
2: Validation
BS EN 60204-1:2006+A1:2009
Safety of machinery. Electrical equipment of machines. General
requirements
BS EN ISO 15883-1:2009 +A1:2014
Washer-disinfectors. General requirements, terms and definitions
and test
MDD 93/42/EEC
Medical Device Directive
BS EN ISO 15883-2:2009
Washer-disinfectors - Requirements and tests for washer-disinfectors
employing thermal disinfection for surgical instruments, anaesthetic
equipment, bowls, dishes, receivers, utensils, glassware, etc.
BS EN 61010-1:2010
Safety requirements for electrical equipment for measurement,
control, and laboratory use
BS EN 61010-2-040:2015
Particular requirements for sterilizers and washer-disinfectors used to
treat medical materials
BS EN 60601-1-6:2010+A1:2015
Medical electrical equipment. General requirements for basic safety
and essential performance
BS EN 60601-1:2006 +A12:2014
Medical electrical equipment. General requirements for basic safety
and essential performance
BS EN 60601-1-2:2007
Medical electrical equipment. General requirements for basic safety
and essential performance. Collateral Standard. Electromagnetic
disturbances. Requirements and tests
BS EN 62366-1:2015
Medical devices. Application of usability engineering to medical
devices
BS EN ISO 13485:2012 Medical devices - Quality management systems
BS EN ISO 14971:2012 Medical devices - Application of risk management to medical devices
PD IEC/TR 60878:2015
Graphical symbols for electrical equipment in medical practice
BS EN 1717:2000
Protection against pollution of potable water in water installations and
general requirements of devices to prevent pollution by backflow
PD 5304:2014
Guidance on the safe use of machinery
EN 61326: 2013
Electrical equipment for measurement, control and laboratory use.
EMC requirements. General requirements
2003/10/EC
Minimum health and safety requirements regarding the exposure of
workers to the risks arising from physical agents (noise)
2009/104/EC
Minimum safety and health requirements for the use of work
equipment by workers at work