FOREWORD
INTRODUCTION
1 Scope
1.1 Purpose
1.2 Field of application
2 Terms and Definitions
3 Roles and responsibilities
3.1 General
3.2 RESPONSIBLE ORGANIZATION
3.3 TOP MANAGEMENT
3.4 MEDICAL IT-NETWORK RISK MANAGER
3.5 MEDICAL DEVICE manufacturer(s)
3.6 Other providers of information technology
4 Life cycle RISK MANAGEMENT in MEDICAL
IT-NETWORKS
4.1 Overview
4.2 RESPONSIBLE ORGANIZATION RISK MANAGEMENT
4.3 MEDICAL IT-NETWORK RISK MANAGEMENT
Planning and Documentation
4.4 CHANGE-RELEASE MANAGEMENT and CONFIGURATION
MANAGEMENT
4.5 Live Network RISK MANAGEMENT
5 Document control
5.1 Document control procedure
5.2 MEDICAL IT-NETWORK RISK MANAGEMENT FILE
Annex A (Informative) - Rationale
Annex B (Informative) - Overview of RISK MANAGEMENT
relationships
Annex C (Informative) - Guidance on field of application
Annex D (Informative) - Relationship with ISO/IEC 20000
Information technology - Service management
Annex E - Bibliography