New VDA 4: 2020, English version 2021 is avilable here.

 

11.040.01 Medical equipment in general

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immediate download
Released: 2014-12-16
PD IEC/TR 80001-2-5:2014
Application of risk management for IT-networks incorporating medical devices Application guidance. Guidance on distributed alarm systems
LANGUAGE
English
immediate download
Released: 2016-05-19
PD IEC/TR 80001-2-8:2016
Application of risk management for IT-networks incorporating medical devices Application guidance. Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
LANGUAGE
English
immediate download
Released: 2017-01-30
PD IEC/TR 80001-2-9:2017
Application of risk management for it-networks incorporating medical devices Application guidance. Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
LANGUAGE
English
immediate download
Released: 2009-09-23
PD IEC/TR 80002-1:2009
Medical device software Guidance on the application of ISO 14971 to medical device software
LANGUAGE
English
immediate download
Released: 2014-06-04
PD IEC/TR 80002-3:2014
Medical device software Process reference model of medical device software life cycle processes (IEC 62304)
LANGUAGE
English
immediate download
Released: 2019-08-21
PD ISO/IEC GUIDE 63:2019
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
LANGUAGE
English
immediate download
Released: 2013-02-28
PD ISO/PAS 18761:2013
Use and handling of medical devices covered by the scope of ISO/TC 84. Risk assessment on mucocutaneous blood exposure
LANGUAGE
English
immediate download
Released: 2014-08-31
PD ISO/TR 19244:2014
Guidance on transition periods for standards developed by ISO/TC 84. Devices for administration of medicinal products and catheters
LANGUAGE
English
immediate download
Released: 2014-11-30
PD ISO/TR 80001-2-6:2014
Application of risk management for IT-networks incorporating medical device Application guidance. Guidance for responsibility agreements
LANGUAGE
English
immediate download
Released: 2015-03-31
PD ISO/TR 80001-2-7:2015
Application of risk management for IT-networks incorporating medical devices. Application guidance Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
LANGUAGE
English
immediate download
Released: 2017-10-31
PD ISO/TR 80002-2:2017
Medical device software Validation of software for medical device quality systems
LANGUAGE
English
immediate download
Released: 2012-05-31
PD ISO/TS 19218-2:2012
Medical devices. Hierarchical coding structure for adverse events Evaluation codes
LANGUAGE
English