11.040.01 Medical equipment in general
CURRENCY
PRICES include / exclude VAT
Price include VAT will be charged for customers of European Union – non VAT payers.
Price exclude VAT will be charged for customers of European Union – VAT payers (with valid EU VAT number) and for customers outside of European Union.
Price exclude VAT will be charged for customers of European Union – VAT payers (with valid EU VAT number) and for customers outside of European Union.
immediate download
Released: 2014-12-16
Application of risk management for IT-networks incorporating medical devices Application guidance. Guidance on distributed alarm systems
immediate download
Released: 2016-05-19
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
immediate download
Released: 2017-01-30
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
immediate download
Released: 2009-09-23
Medical device software Guidance on the application of ISO 14971 to medical device software
immediate download
Released: 2014-06-04
Medical device software Process reference model of medical device software life cycle processes (IEC 62304)
immediate download
Released: 2019-08-21
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
immediate download
Released: 2013-02-28
Use and handling of medical devices covered by the scope of ISO/TC 84. Risk assessment on mucocutaneous blood exposure
immediate download
Released: 2014-08-31
Guidance on transition periods for standards developed by ISO/TC 84. Devices for administration of medicinal products and catheters
immediate download
Released: 2014-11-30
Application of risk management for IT-networks incorporating medical device Application guidance. Guidance for responsibility agreements
immediate download
Released: 2015-03-31
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
immediate download
Released: 2017-10-31
Medical device software Validation of software for medical device quality systems
immediate download
Released: 2012-05-31
Medical devices. Hierarchical coding structure for adverse events Evaluation codes