ISO/TR 80001-2-6:2014
Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements
OVERVIEW
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.
COMMENTS
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PRODUCT DETAILS
| Status | Withdrawn - 06 Jan 2026 |
|---|---|
| Edition | 2014 |
| No. of Pages | 15 |
| ICS Classification | 11.040.01 Medical equipment in general 35.240.80 IT applications in health care technology |
| Committee | ISO/TC 215 |
| Available for Purchase | For sale in Singapore only |
| Adoption | ISO |