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About This Item
Full Description
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.
All current amendments available at time of purchase are included with the purchase of this document.
Document History
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BS EN IEC 80001-1:2021
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Application of risk management for IT-networks incorporating medical devices-Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software- Most Recent
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BS EN 80001-1:2011
Application of risk management for IT-networks incorporating medical devices-Roles, responsibilities and activities- Historical Version
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BS 09/30157835 DC
BS EN ISO/IEC 80001-1. Application of risk management for IT-networks incorporating medical devices. Part 1. Roles, responsibilities and activities- Historical Version