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IEC 80001-1:2021 (EN-FR)

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

Standard Details

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.

General Information

Status : ACTIVE
Standard Type: Main
Document No: IEC 80001-1:2021 (EN-FR)
Document Year: 2021
Pages: 75
Edition: 2.0
  • Section Volume:
  • TC 62.SC 62A Common aspects of electrical equipment used in medical practice
  • ICS:
  • 11.040.01 Medical equipment in general
  • 35.240.80 IT applications in health care technology

Life Cycle

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IEC 80001-1:2021 (EN-FR)
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