IEC 80001-1:2021
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
Abstract
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.
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.
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Additional information
| Publication type | International Standard |
|---|---|
| Publication date | 2021-09-21 |
| Edition | 2.0 |
| Available language(s) | English/French |
| TC/SC | TC 62/SC 62A - Common aspects of medical equipment, software, and systemsrss |
| ICS | 11.040.01 - Medical equipment in general 35.240.80 - IT applications in health care technology |
| Stability date | 2026 |
| Pages | 75 |
| File size | 2307 KB |
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