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11.040.01 Lékařská zařízení/Zdravotnické prostředky obecně

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BS EN ISO 15378:2017+A1:2024 - TC
Tracked Changes. Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)

Vydáno: 2024-11-14

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PD CEN ISO/TR 20416:2020
Medical devices. Post-market surveillance for manufacturers

Vydáno: 2020-08-19

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PD IEC/TR 62366-2:2016
Medical devices Guidance on the application of usability engineering to medical devices

Vydáno: 2016-04-27

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BS EN IEC 60332-3-25:2018
Tests on electric and optical fibre cables under fire conditions Test for vertical flame spread of vertically-mounted bunched wires or cables. Category D

Vydáno: 2018-10-19

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BS EN IEC 80601-2-60:2020 - TC
Tracked Changes. Medical electrical equipment Particular requirements for the basic safety and essential performance of dental equipment

Vydáno: 2020-11-12

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PD ISO/IEC GUIDE 63:2019
Guide to the development and inclusion of aspects of safety in International Standards for medical devices

Vydáno: 2019-08-21

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PD IEC TR 60601-4-5:2021
Medical electrical equipment Guidance and interpretation. Safety-related technical security specifications

Vydáno: 2021-01-28

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BS ISO/CIE 17166:2019
Erythema reference action spectrum and standard erythema dose

Vydáno: 2019-06-03

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PD CEN/TR 17223:2018
Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

Vydáno: 2018-03-21

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BS EN IEC 80601-2-30:2019
Medical electrical equipment Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

Vydáno: 2019-07-03

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BS ISO/CIE 17166:2019 - TC
Tracked Changes. Erythema reference action spectrum and standard erythema dose

Vydáno: 2020-02-24

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BS EN ISO 20417:2021
Medical devices. Information to be supplied by the manufacturer

Vydáno: 2022-05-27

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121 results

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