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

(a) Are you unable to work or is your work limited because of illnesses, injuries, or conditions? (c) Are you blind or do you have low vision even with glasses or contacts?

Sep 21, 2021 · 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 INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders.

IEC 80001-1 Edition 2.0 2021-09 INTERNATIONAL STANDARD NORME INTERNATIONALE 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 80001-1:2010 applies to responsible organizations, medical device manufacturers and providers of other information technology for the purpose of risk management of an IT-network incorporating medical devices as specified by the responsible organization.

Sep 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.

Jul 9, 2021 · IEC 81001-5-1 complements IEC 62304 with tasks related to cyber security. IEC/TR 60601-4-5 defines a list of security requirements to be injected in your Hardware Requirement Specification (HRS), Software Requirement Specification (SRS), and accompanying documents. These two standards work together.

This document 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 INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders.