NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 11608-4 [CURRENT] references following documents:

Document number Edition Title
DIN EN 62304 ; VDE 0750-101:2016-10 2016-10 Medical device software - Software life-cycle processes (IEC 62304:2006 + A1:2015); German version EN 62304:2006 + Cor.:2008 + A1:2015 More 
DIN EN 62366-1 ; VDE 0750-241-1:2021-08 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 More 
DIN ISO 3534-1 2009-10 Statistics - Vocabulary and symbols - Part 1: General statistical terms and terms used in probability (ISO 3534-1:2006); Text in German and English More 
IEC 60112 2020-10 Method for the determination of the proof and the comparative tracking indices of solid insulating materials More 
IEC 60601-1-6 2010-01 Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Usability More 
IEC 60601-1-8 2006-10 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems More 
IEC 60664-1 2020-05 Insulation coordination for equipment within low-voltage supply systems - Part 1: Principles, requirements and tests More 
IEC 62368-1 2018-10 Audio/video, information and communication technology equipment - Part 1: Safety requirements More 
ISO 11608-2 2022-04 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles More 
ISO 11608-3 2022-04 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths More