| Publication CODE |
Title |
| ISO TR 80001-2-6:2014 (2014-11) |
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES -- PART 2-6: APPLICATION GUIDANCE -- GUIDANCE FOR RESPONSIBILITY AGREEMENTS |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
102.00 €
|
15. |
Description
ISO/TR 80001-2-6:2014 provides guidance on implementing RESPONSIBILITY AGREEMENTS, which are described in IEC 80001-1 as used to establish the roles and responsibilities among the stakeholders engaged in the incorporation of a MEDICAL DEVICE into an IT-NETWORK in order to support compliance to IEC 80001-1. Stakeholders may include RESPONSIBLE ORGANIZATIONS, IT suppliers, MEDICAL DEVICE manufacturers and others. The goal of the RESPONSIBILITY AGREEMENT is that these roles and responsibilities should cover the complete lifecycle of the resulting MEDICAL IT-NETWORK.
|
| Class |
C990
(IEC PUBLICATIONS IEC PUBLICATIONS)
|
| Status |
IEC PUBLICATION |
| Situation |
Currently active
|
|
| Committee |
TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
|
| Responsible |
De heer VAN HECKE Luk
|
| BEC Approval |
2014-11-20 |
| ICS-Code (International Standards Classification) |
11.040.01
, 35.240.80
|
| NBN Status |
New |
|
| IEC publication date |
2014-11-20 |
| IEC stability date |
2022-12-31 |
| IEC file modification date |
2014-12-05 |
| IEC last modification date |
2019-10-31 |
|
