GE Vscan Air, Руководство пользователя

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Vscan Air
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User Manual
i-5
Direction GP092020-1EN Rev 18
ISO10993-1 Biological evaluation of medical devices
EN 300 328 Electromagnetic compatibility and Radio spectrum Matters
(ERM); Wideband transmission systems
ISO 14971 Medical devices — Application of risk management to
medical devices
IEC* 62304 Medical device software — Software life-cycle processes
IEC* 62366-1 Medical devices — Application of usability engineering to
medical devices
IEC 60601-1-11 Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
IEC 60601-1-12 Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency
medical services environment
EN13718-1 Medical vehicles and their equipment — Air ambulances,
Part 1: Requirements for medical devices used in air
ambulances
EN1789 Medical vehicles and their equipment — Road ambulances
ISO15223 Medical devices — Symbols to be used with medical device
labels, labelling and information to be supplied — Part 1:
General requirements
EN1041 Information supplied by the manufacturer with medical
devices
IEC 62209-2 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)
ISO 17664 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.
2015/863/EU Annex II to Directive 2011/65/EU of the European
Parliament and of the Council as regards the list of restricted
substances (RoHS 3).
* including national deviations
Table i-1: Regulatory requirements (Continued)
Standard/Directive Scope