NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 82304-1 ; VDE 0750-102-1:2018-04 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 80601-2-30 Corrigendum 1 | 2010-01 | Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygnomanometers; Corrigendum 1 More |
| IEC 80601-2-58 Edition 2.1 | 2016-10 | Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery More |
| IEC 80601-2-59 | 2017-09 | Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening More |
| IEC 80601-2-71 | 2015-06 | Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional Near-Infrared Spectroscopy (NIRS) equipment More |
| IEC 82304-1 | 2016-10 | Health software - Part 1: General requirements for product safety More |
| IEC/TR 80001-2-2 | 2012-07 | Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls More |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
| ISO 14708-1 | 2014-08 | Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer More |
| ISO 14708-3 | 2017-04 | Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators More |
| ISO 9000 | 2015-09 | Quality management systems - Fundamentals and vocabulary More |
