ISO TR 24971:2020

Medical devices - Guidance on the application of ISO 14971

IEC 60601-2-31:2020

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

IEC 60601-2-31:2020 RLV

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

ISO 14971:2019

Medical devices - Application of risk management to medical devices

ISO/IEC GUIDE 63:2019

Guide to the development and inclusion of aspects of safety in International Standards for medical devices

IEC 80601-2-77:2019

Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

IEC 80601-2-78:2019

Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

IEC 80601-2-60:2019

Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

IEC 80601-2-26:2019

Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalograph

IEC TR 61289:2019

High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance

IEC TR 61289:2019 RLV

High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance

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 80601-2-30:2018

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

IEC 80601-2-30:2018 RLV

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

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 60601-2-75:2017

Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment

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