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Standards Worldwide
Standards Worldwide
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Medizintechnik

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Draft standard 2024-09

DIN 91422:2024-09 - Draft
Requirements for planning and safety in the multifunctional high-tech working environment surgical theatre/interventional suite

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Standard [CURRENT] 2022-11

DIN EN 60601-1:2022-11; VDE 0750-1:2022-11
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor1:2006 + Cor2:2007 + A1:2012 + A1:2012/Cor1:2014 + A2:2020); German version EN 60601-1:2006 + Cor.:2010 + A1:2013 + AC:2014 + A1:2013/AC:2014 + A12:2014 + A2:2021

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Standard [CURRENT] 2022-01

DIN EN 60601-1-2:2022-01; VDE 0750-1-2:2022-01
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014 + A1:2020); German version EN 60601-1-2:2015 + A1:2021

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Standard [CURRENT] 2021-11

DIN EN 60601-1-6:2021-11; VDE 0750-1-6:2021-11
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010 + A1:2013 + A2:2020); German version EN 60601-1-6:2010 + A1:2015 + A2:2021

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Standard [CURRENT] 2021-05

DIN EN 60601-1-9:2021-05; VDE 0750-1-9:2021-05
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design (IEC 60601-1-9:2007 + A1:2013 + A2:2020); German version EN 60601-1-9:2008 + A1:2013 + A2:2020

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Standard [CURRENT] 2021-11

DIN EN 60601-1-10:2021-11; VDE 0750-1-10:2021-11
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 60601-1-10:2007 + A1:2013 + A2:2020); German version EN 60601-1-10:2008 + A1:2015 + A2:2021

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Standard [CURRENT] 2021-12

DIN EN 60601-1-11:2021-12; VDE 0750-1-11:2021-12
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 + A1:2020); German version EN 60601-1-11:2015 + A1:2021

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Draft standard 2024-10

DIN EN IEC 61340-6-1/A1:2024-10; VDE 0300-6-1/A1:2024-10 - Draft
Electrostatics - Part 6-1: Electrostatic control for healthcare - General requirements for facilities (IEC 101/700/CDV:2023); German and English version EN IEC 61340-6-1:2018/prA1:2023

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Standard [CURRENT] 2016-10

DIN EN 62304:2016-10; VDE 0750-101:2016-10
Medical device software - Software life-cycle processes (IEC 62304:2006 + A1:2015); German version EN 62304:2006 + Cor.:2008 + A1:2015

This standard defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical ...

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Standard [CURRENT] 2021-08

DIN EN 62366-1:2021-08; VDE 0750-241-1:2021-08
Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016 + A1:2020); German version EN 62366-1:2015 + AC:2015 + A1:2020

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