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11.040.01 Lékařská zařízení/Zdravotnické prostředky obecně

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PD ISO/PAS 18761:2013
Use and handling of medical devices covered by the scope of ISO/TC 84. Risk assessment on mucocutaneous blood exposure

Vydáno: 2013-02-28

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BS EN 60601-1-2:2015+A1:2021
Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic disturbances. Requirements and tests

Vydáno: 2021-03-24

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PD IEC/TR 80001-2-1:2012
Application of risk management for IT-networks incorporating medical devices Step-by-step risk management of medical IT-networks. Practical applications and examples

Vydáno: 2012-07-10

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PD CEN ISO/TR 24971:2020 - TC
Tracked Changes. Medical devices. Guidance on the application of ISO 14971

Vydáno: 2020-08-14

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PD IEC/TR 80001-2-4:2012
Application of risk management for IT-networks incorporating medical devices Application guidance. General implementation guidance for healthcare delivery organizations

Vydáno: 2012-11-29

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BS EN 60601-1:2006+A2:2021
Medical electrical equipment General requirements for basic safety and essential performance

Vydáno: 2021-11-02

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BS EN 15986:2011
Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates

Vydáno: 2011-03-31

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BS EN 60601-1-10:2008+A2:2021
Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for the development of physiologic closed-loop controllers

Vydáno: 2021-08-16

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BS EN ISO 389-3:2016
Acoustics. Reference zero for the calibration of audiometric equipment Reference equivalent threshold vibratory force levels for pure tones and bone vibrators

Vydáno: 2016-02-29

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BS EN ISO 15223-1:2021 (CD-ROM+PDF)
Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied General requirements

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PD IEC/TR 80001-2-9:2017
Application of risk management for it-networks incorporating medical devices Application guidance. Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities

Vydáno: 2017-01-30

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PD IEC/TR 60601-4-3:2018
Medical electrical equipment Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements

Vydáno: 2019-01-04

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121 results

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