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sklademVydáno: 2021-01-28
PD IEC TR 60601-4-5:2021
Medical electrical equipment Guidance and interpretation. Safety-related technical security specifications
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Označení normy: | PD IEC TR 60601-4-5:2021 |
Počet stran: | 54 |
Vydáno: | 2021-01-28 |
ISBN: | 978 0 539 05359 3 |
Status: | Standard |
DESCRIPTION
PD IEC TR 60601-4-5:2021
This standard PD IEC TR 60601-4-5:2021 Medical electrical equipment is classified in these ICS categories:
- 11.040.01 Medical equipment in general
This document is applicable to MEDICAL DEVICES with external data interface(s), for example when connected to a MEDICAL IT-NETWORK or when a human interface is used for processing – e.g. entering, capturing or viewing – CONFIDENTIAL DATA.
This document does not apply to other software used on a MEDICAL IT-NETWORK which does not meet the definition of MEDICAL DEVICE SOFTWARE.
This document does not apply to in-vitro diagnostic devices (IVD).