ISO 14971:2019 Medical devices - Application of risk management to medical devices
€189.00
ISO TR 24971:2020 Medical devices - Guidance on the application of ISO 14971
€237.00
IEC 61847:1998 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
€302.00
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
€499.00
IEC TR 61258:2008 Guidelines for the development and use of medical electrical equipment educational materials
€93.00
IEC TR 60930:2008 Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
€244.00
IEC TR 62296:2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
€441.00
IEC TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
IEC TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
€342.00
IEC TR 80001-2-2:2012 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
€389.00
IEC TR 80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples
IEC TR 80001-2-4:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations
€186.00
IEC TR 62348:2012 Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition
€470.00
IEC TR 80002-3:2014 Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
IEC TR 62354:2014 General testing procedures for medical electrical equipment
€551.00