Standard:
DIN EN 60601-2-45 VDE 0750-2-45:2017-01Medical electrical equipment Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
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DIN EN 60601-2-37 VDE 0750-2-37:2016-11Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
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DIN EN 60601-2-18 VDE 0750-2-18:2016-10Medical electrical equipment Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
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DIN EN 60601-2-5 VDE 0750-2-5:2016-08Medical electrical equipment Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
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DIN EN 60601-2-8 VDE 0750-2-8:2016-08Medical electrical equipment Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV |
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DIN EN 60601-2-23 VDE 0750-2-23:2016-08Medical electrical equipment Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment |
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DIN EN 60601-2-25 VDE 0750-2-25:2016-08Medical electrical equipment Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
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DIN EN 60601-2-11 VDE 0750-2-11:2016-04Medical electrical equipment Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment |
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DIN EN 60601-2-24 VDE 0750-2-24:2016-04Medical electrical equipment Part 2-24: Particular requirements for basic safety and essential performance of infusion pumps and controllers |
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DIN EN 60601-2-62 VDE 0750-2-62:2016-04Medical electrical equipment Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment |
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DIN EN 60601-2-17 VDE 0750-2-17:2016-03Medical electrical equipment Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment |
Standard:
DIN IEC/TR 80001-2-5 VDE 0756-2-5:2016-03Application of risk management for IT-networks incorporating medical devices Part 2-5: Application guidance – Guidance on distributed alarm systems |
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DIN EN 60601-2-47 VDE 0750-2-47:2016-02Medical electrical equipment Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
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DIN EN 45502-1 VDE 0750-10:2016-02Implants for surgery – Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer; |
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DIN EN 60601-2-36 VDE 0750-2-36:2015-11Medical electrical equipment Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy |
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DIN EN 62353 VDE 0751-1:2015-10Medical electrical equipment Recurrent test and test after repair of medical electrical equipment |
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DIN EN 60601-2-27 VDE 0750-2-27:2015-04Medical electrical equipment Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
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DIN EN 60601-2-34 VDE 0750-2-34:2015-01Medical electrical equipment Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
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DIN EN 60601-2-2 VDE 0750-2-2 Beiblatt 1:2014-02Medical electrical equipment Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories – Supplement 1: High frequency surgical equipment – Operation and maintenance An english translation of this document is available. |
Anwendungsregel:
VDE-AR-E 2750-200 Anwendungsregel:2013-03Approach to the classification of medical devices and the selection of conformity assessment procedure
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