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prEN IEC 63322
Security of medical electrical equipment containing high-activity sealed radioactive sources
EN ISO 14155/prA11
Clinical investigation of medical devices for human subjects - Good clinical practice
ISO/FDIS 15193
In vitro diagnostic medical devices - Requirements for reference measurement procedures
ISO/DTS 16766
Manufacturers' considerations for in vitro diagnostic medical devices in a public health emergency
ISO/AWI 22246
Packaging for non-sterile medical devices - Requirements for packaging systems
ISO/DIS 14155
Clinical investigation of medical devices for human subjects - Good clinical practice
EN ISO 10993-23/prA1
Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1
IEC 62D/784A/FDIS
IEC 80601-2-35 Ed. 2: Medical electrical equipment - Part 2-35: Particular requirements for basic safety and essential performance of blankets, pads and mattresses, intended for heating in medical use This document cancels and replaces 62D/784/FDIS
IEC 62D/552/CD
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use (IEC 80601-2-35:2009)
DIN EN IEC 80601-2-78/A1
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation (IEC 62D/1884/CDV:2021); German and English version EN IEC 80601-2-78:2020/prA1:2021