IEC 60601-1 fI3 Ed. 3.0  

Interpretation Sheet 3 - Interpretation sheet for Publication IEC 60601-1:2005 and IEC 60601-1:2005 + A1:2012 (Editions 3 - 2005 and 3.1 - 2012) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-10 am1 Ed. 1.0  

Amendment 1 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

IEC 60601-1-12 Ed. 1.0  

Medical Electrical Equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment

IEC 60601-1-2 Ed. 4.0  

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic phenomena - Requirements and tests

IEC 60601-1-6 am1 Ed. 3.0  

Amendment 1 - IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: General requirement for basic safety and essential performance - Collateral standard: Usability

IEC 60601-1-9 am1 Ed. 1.0  

Amendment 1 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

IEC 62304 Ed. 2.0  

Medical device software - Software life cycle processes

IEC 62353 Ed. 2.0  

Medical electrical equipment Recurrent test and test after repair of medical electrical equipment

IEC 62366 am1 Ed. 1.0  

Amendment 1 - Medical devices - Application of usability engineering to medical devices

IEC 62366-1 Ed. 1.0  

Medical devices - Part 1: Application of usability engineering to medical devices

IEC 62366-2 Ed. 1.0  

Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

IEC 82304-1 Ed. 1.0  

Healthcare Software Systems - Part 1: General requirements

IEC/TR 80001-2-5 Ed. 1.0  

Application of risk management for IT-networks incorporating medical devices - Part 2-x: Guidance on distributed alarm systems

ISO/TR 17791 Ed. 1.0  

Health informatics - Guidance on Standards for Enabling Safety in Health Software

ISO/TR 24971 Ed. 1.0  

Guidance on the application of ISO 14971

ISO/TR 80002-2 Ed. 1.0  

Medical device software - Part 2: Validation of software for regulated processes

PNW/TR 62A-843 Ed. 1.0  

ISO/TR 80001-2-x: Application of risk management for IT-networks incorporating medical devices - Part 2-x Guidance for responsibility agreements

PNW/TR 62A-856 Ed. 1.0  

ISO/TR 80001-2-x: Application of risk management for IT-networks incorporating medical devices - Part 2-x: Application Guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1