| Publication CODE |
Title |
| NBN EN IEC 80001-1:2021 (2021-11) |
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 |
|
12.00 €
|
2. |
Description
This document 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.
|
| Class |
C
|
Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally
only available in English or French. Only the cover page is translated
and the document itself is in English or in French.
|
DE version
|
EN version
|
FR version
|
|
| Committee |
CLC/TC 62
Electrical equipment in medical practice
|
| BEC Approval |
2021-10-26 |
| NBN Approval |
2021-11-03 |
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2021-10-26 |
| Date of announcement (d.o.a.) |
2022-01-26 |
| IEC file modification date |
2021-10-30 |
|
