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

IEC-80001-1 - EDITION 2.0 - CURRENT
Show Complete Document History

Document Center Inc. is an authorized dealer of IEC standards.
The following bibliographic material is provided to assist you with your purchasing decision:


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 80001-1:2021 cancels and replaces the first edition published in 2010. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) structure changed to better align with ISO 31000;
b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT;
c) communication of the value, intention and purpose of RISK MANAGEMENT through principles that support preservation of the KEY PROPERTIES during the implementation and use of connected HEALTH SOFTWARE and/or HEALTH IT SYSTEMS.
ORDER

Price:

$259.00        


Want this as a site license?

To find similar documents by classification:

11.040.01 (Medical equipment in general)

35.240.80 (IT applications in health care technology Including computer tomography)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

 

Customers who bought this document also bought:

IEC-60601-1
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

ASTM-D4169
Standard Practice for Performance Testing of Shipping Containers and Systems

ISO-13485
Medical devices - Quality management systems - Requirements for regulatory purposes

Document Number

IEC 80001-1 Ed. 2.0 b:2021

Revision Level

EDITION 2.0

Status

Current

Publication Date

Sept. 1, 2021

Committee Number

62A