IEC 80001-1:2021 PRV
Pre release version
Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management
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.
|Publication type||International Standard|
|TC/SC||TC 62/SC 62A - Common aspects of electrical equipment used in medical practicerss|
|ICS||11.040.01 - Medical equipment in general|
35.240.80 - IT applications in health care technology
|File size||1376 KB|
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