| Publication CODE |
Title |
| IEC 80001-1:2021 (2021-09) |
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 |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
249.00 €
|
75. |
Description
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.
|
| Class |
C990
(IEC PUBLICATIONS IEC PUBLICATIONS)
|
| Committee |
TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
|
| Responsible |
De heer VAN HECKE Luk
|
| BEC Approval |
2021-09-21 |
| ICS-Code (International Standards Classification) |
11.040.01
, 35.240.80
|
| NBN Status |
New |
|
| IEC publication date |
2021-09-21 |
| IEC stability date |
2026-12-31 |
| IEC file modification date |
2021-09-21 |
| IEC last modification date |
2021-09-21 |
|
