IEC - International Electrotechnical Commission - IEC 80001-1:2021
Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
published
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Organization: | IEC - International Electrotechnical Commission |
Publication Date: | 21 September 2021 |
Status: | published |
Page Count: | 75 |
ICS Code (Medical equipment in general): | 11.040.01 |
ICS Code (IT applications in health care technology): | 35.240.80 |
abstract:
IEC 80001-1:2021 specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT... View More
Document History

IEC 80001-1:2021
September 21, 2021
Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
IEC 80001-1:2021 specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT...

October 27, 2010
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
IEC 80001-1:2010 Recognizing that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), defines the roles, responsibilities and activities...