IEC 60601-1:2020 SER

Medical electrical equipment - ALL PARTS

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

IEC TR 60601-4-3:2018 RLV

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

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

ISO TR 80002-2:2017

Medical device software - Part 2: Validation of software for medical device quality systems

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 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 82304-1:2016

Health software - Part 1: General requirements for product safety

IEC 62366-1:2015/COR1:2016

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

IEC TR 80001-2-8:2016

Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2

IEC TR 60601-4-2:2016

Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

IEC TR 62366-2:2016

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

IEC TR 60878:2015

Graphical symbols for electrical equipment in medical practice

IEC 62304:2006/AMD1:2015

Amendment 1 - Medical device software - Software life cycle processes

IEC 62304:2006+AMD1:2015 CSV (Consolidated Version)

Medical device software - Software life cycle processes

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

IEC 62366-1:2015

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

IEC 60601-1-11:2015

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC 60601-1-11:2015 RLV

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC TR 80001-2-5:2014

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems