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11.040.01 Lékařská zařízení/Zdravotnické prostředky obecně

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PD CEN ISO/TR 24971:2020 ExComm - SET
Medical devices. Guidance on the application of ISO 14971

Vydáno: 2020-06-19

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BS EN ISO 389-8:2004
Acoustics. Reference zero for the calibration of audiometric equipment Reference equivalent threshold sound pressure levels for pure tones and circumaural earphones

Vydáno: 2004-06-08

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BS EN 62353:2014
Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment

Vydáno: 2014-12-31

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BS EN 60601-1-9:2008+A2:2020
Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for environmentally conscious design

Vydáno: 2020-09-14

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PD IEC/TR 62354:2014
General testing procedures for medical electrical equipment

Vydáno: 2014-09-25

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BS EN 62304:2006+A1:2015
Medical device software. Software life-cycle processes

Vydáno: 2015-11-30

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BS EN IEC 60601-2-31:2020
Medical electrical equipment Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

Vydáno: 2023-01-27

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24/30506281 DC
BS EN IEC 60601-1/FRAG3 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - User interface hazards (Fragment 3)

Vydáno: 2024-12-06

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BS EN ISO 13485:2016
Medical devices. Quality management systems. Requirements for regulatory purposes

Vydáno: 2017-01-31

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23/30472825 DC
BS IEC 80601-2-31. Medical electrical equipment Part 2-31. Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

Vydáno: 2023-04-12

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23/30476395 DC
BS EN IEC 60601-2-93. Medical electrical equipment Part 2-93. Particular requirements for the basic safety and essential performance of neutron capture therapy equipment

Vydáno: 2023-07-05

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PD IEC/TR 62296:2009
Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements

Vydáno: 2009-01-22

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