VitaScan LT
User and Service Manual
Applicable Standards/Approvals
93/42/EEC Council Directive concerning medical devices
EN ISO 13485:2012+ AC:2012 Medical devices- Quality management systems-
Requirements for regulatory purposes
EN ISO 14971:2012 Medical devices – Application of risk management to medical
devices
EN ISO 14155:2011 Clinical investigation of medical devices for human subjects — Good
clinical practice
EN 60601-1:2006+ AC:2010 + A1:2013 Medical electrical equipment -- Part 1: General
requirements for basic safety and essential performance
EN 60601-1-1:2001 Medical electrical equipment. Part 1-1: General requirements for
safety. Collateral standard: Safety requirements for medical electrical systems (IEC 60601-
1- 1:2000)
EN 60601-1-2:2015 Medical electrical equipment Part 1: General requirements for
safety 2.Collateral Standard: Electromagnetic compatibility - Requirements and tests
EN 60601-1-4: 1996+ A1:1999 Medical electrical equipment-Part 1-4 General
requirements for safety- Collateral Standard: Programmable electrical medical systems
EN 60601-1-6:2010 Medical electrical equipment-Part 1-6: General requirements for
safety- Collateral Standard: Usability
EN 60601-2-37:2008+A11:2011 Medical electrical equipment-Part 2-37: Particular
requirements for the safety of ultrasonic medical diagnostic and monitoring equipment)
EN 62304:2006+АС:2008 Medical device software – Software life-cycle processes
EN 62366:2008 Medical Devices. Application of usability engineering to medical devices
EN 60529:1991+A1:2000 Degrees of protection provided by enclosures (IP code)
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