GE Vscan Air Manual page 7

Standard/Directive
ISO10993-1
EN 300 328
ISO 14971
IEC* 62304
IEC* 62366-1
IEC 60601-1-11
IEC 60601-1-12
EN13718-1
EN1789
ISO15223
EN1041
IEC 62209-2
ISO 17664
2015/863/EU
* including national deviations
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Vscan Air User Manual
Direction GP092020-1EN Rev 18
Table i-1: Regulatory requirements (Continued)
Biological evaluation of medical devices
Electromagnetic compatibility and Radio spectrum Matters
(ERM); Wideband transmission systems
Medical devices — Application of risk management to
medical devices
Medical device software — Software life-cycle processes
Medical devices — Application of usability engineering to
medical devices
Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency
medical services environment
Medical vehicles and their equipment — Air ambulances,
Part 1: Requirements for medical devices used in air
ambulances
Medical vehicles and their equipment — Road ambulances
Medical devices — Symbols to be used with medical device
labels, labelling and information to be supplied — Part 1:
General requirements
Information supplied by the manufacturer with medical
devices
Human exposure to radio frequency fields from hand-held
and body-mounted wireless communication devices —
Human models, instrumentation, and procedures — Part 2:
Procedure to determine the specific absorption rate (SAR)
for wireless communication devices used in close proximity
to the human body (frequency range of 30 MHz to 6 GHz)
Specifies requirements for the information to be provided by
the medical device manufacturer for the processing of a
medical device that requires cleaning followed by
disinfection and/or sterilization to ensure that the device is
safe and effective for its intended use.
This includes information for processing prior to use or reuse
of the medical device. The provisions of ISO 17664:2017 are
applicable to medical devices that are intended for invasive
or other direct or indirect patient contact.
Annex II to Directive 2011/65/EU of the European
Parliament and of the Council as regards the list of restricted
substances (RoHS 3).
Scope
i-5