Classification; Safety - Philips V60 User Manual

Regulatory compliance

Classification

Safety

D-8
Protection Against Electric
Shock
Degree of Protection Against
Electric Shock
Degree of protection against
ingress of particulate matter
and water given by the enclo-
sure
Mode of operation
Method of sterilization
Suitability for use in an
O -rich environment
2
IEC 60601-1; Medical electrical equipment – Part 1: General requirements for
2012, Ed. 3.1 basic safety and essential performance
IEC 60601-1-6; Medical electrical equipment – Part 1-6: General requirements for
2013, Ed. 3.1 basic safety and essential performance; collateral standard: usabil-
ity
IEC 60601-1-8; Medical electrical equipment – Part 1-8: General requirements for
2012, Ed. 2.1 basic safety and essential requirements; collateral standard - alarm
systems
IEC 62366-1, Medical devices - Application of usability engineering to medical
2015, Ed. 1.1 devices
ISO 14971; 2007 Medical devices – Application of risk management to medical de-
vices
EN ISO 14971; Medical devices – Application of risk management to medical de-
2012 vices
ISO 80601-2-12; Medical electrical equipment – Particular requirements for basic
2011 safety and essential performance of critical care ventilators
IEC 60529; 2013, Degrees of protection provided by enclosures (IP Code)
Ed. 2.2
IEC 62304; 2015, Medical device software - Software life cycle processes
Ed. 1.1
Class I
Type B
IP21
Protected against solid objects ≥ 12.5 mm in diameter.
Protected against vertically falling water drops when en-
closure is tilted up to 15°
Continuous Operation
Not intended to be sterilized
Not suitable