CENELEC - EN IEC 80001-1
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
active, Most Current
| Organization: | CENELEC |
| Publication Date: | 1 October 2021 |
| Status: | active |
| Page Count: | 42 |
| ICS Code (IT applications in health care technology): | 35.240.80 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
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.
Document History
EN IEC 80001-1
October 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
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,...
March 1, 2011
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and...