AAMI TIR80001 2 6 2014
$75.64
AAMI/IEC TIR80001-2-6:2014 – Application of risk management for IT-networks incorporating medical-Application guidance-Part 2-6: Guidance for responsibility agreements
| Published By | Publication Date | Number of Pages |
| AAMI | 2014 | 25 |
Provides guidance for stakeholders on implementing RESPONSIBILITY AGREEMENTS 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 ANSI/AAMI/IEC 80001-1. The goal of the RESPONSIBILITY AGREEMENT is that these roles and responsibilities should cover the complete lifecycle of the resulting MEDICAL IT-NETWORK
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI/ISO TIR80001-2-6:2014, Application of risk management for IT networks incorporating medical — Application guidance —Part 2-6: Guidance for responsibility agreements |
| 3 | Cover page |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report ANSI Registration |
| 6 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 9 | Background of AAMI adoption of ISO TR 80001-2-6 Ed.1 |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 Scope 1.1 Purpose 1.2 Prerequisites 2 Normative References 3 Terms and Definitions |
| 16 | 4 Key aspects for responsibility agreements 4.1 Reasons and rationale 4.2 Participants 4.3 Proposed types of responsibility agreements 4.4 Communication control 4.4.1 Bilateral versus multilateral responsibility agreements 4.4.2 Non-disclosure agreements |
| 17 | 4.4.3 Update of information and documentation 4.5 Responsibility for establishing 4.6 Methods for determination and of responsibilities 4.7 Life cycle considerations 5 Elements of a responsibility agreement |
| 21 | Annex A: RACI chart |
| 22 | Annex B: Typical documents |
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