Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Key aspects for RESPONSIBILITY AGREEMENTS
5 Elements of a RESPONSIBILITY AGREEMENT
Annex A (informative) - RACI chart
Annex B (informative) - Typical documents

Abstract

Gives 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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 215