ISO TR 80001-2-7:2015 Application of risk management for IT-networks incorporating medical devices -- Application guidance -- Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
€237.00
ISO TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
Matériel médico-chirurgical. Évaluation in vitro de la cytotoxicité des matériaux et dispositifs médicaux.
€74.00
Appareils d'électricité médicale - Règles générales.
€95.67
IEC TR 60601-4-3:2018 Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
€499.00
IEC TR 61289:2019 High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance
€244.00
IEC 60601-1-2:2014/AMD1:2020 Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
€302.00
IEC 60601-1-8:2006/AMD2:2020 Amendment 2 - 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
€389.00
IEC 60601-1:2005/AMD2:2020 Amendment 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-2-35:2020 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
€441.00
IEC 60601-1:2005/AMD1:2012/ISH1:2021 Interpretation Sheet 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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IEC TR 80001-2-9:2017 Application of risk management for IT-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
IEC TR 60601-4-1:2017 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
IEC TR 60601-4-4:2017 Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards when creating alarm system-related requirements
€186.00
ISO/IEC GUIDE 63:2019 Guide to the development and inclusion of aspects of safety in International Standards for medical devices
€141.00
