User's Manual

6. Regulatory Information
64 iRay Technology Co., Ltd..
6.1 Medical equipment safety standards
 Medical equipment classification
Type of protection against electrical
shock
External electrical power source equipment Class I
Equipment (medical approved adaptor)
External electrical power source equipment (battery)
Degree of protection against electrical
shock
Type-B applied part
Degree of protection against ingress of
water
IPX3
Mode of operation Continuous operation
Flammable anesthetics 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
 Product safety standards r
MDD (93/42/EEC) Medical Device Directive
Directive 2011/65/EU
Restriction of the use of certain hazardous
substances (RoHS)
EN ISO 13485:2016
Medical devices– Quality management systems–
Requirements for regulatory purposes
EN ISO14971: 2012
Medical device – Application of risk management to
medical devices
IEC 60601 1: 2005 + CORR. 1 (2006) +
CORR. 2 (2007) + AM1 (2012)
Medical electrical equipment –Part 1: General
requirements for basic safety and essential
performance
EN 60601-
1:2006+A11:2011+A1:2013+A12:2014
Medical electrical equipment – Part 1: General
requirements for basic safety and essential
performance
BS EN 60601-1:2006+A11:2011
Medical electrical equipment –Part 1: General
requirements for basic safety and essential
performance