APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-1: STEP-BY-STEP RISK MANAGEMENT OF MEDICAL IT-NETWORKS - PRACTICAL APPLICATIONS AND EXAMPLES
International Electrotechnical Committee
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Prerequisites
5 Study of terms used in RISK MANAGEMENT
6 The steps
7 IEC 80001-1:2010, Clause 4.4: Step by step
8 Practical examples
Annex A (informative) - Common HAZARDS,
HAZARDOUS SITUATIONS, and causes to
consider in MEDICAL IT-NETWORKS
Annex B (informative) - List of questions to consider
when identifying HAZARDs of the MEDICAL IT-NETWORK
Annex C (informative) - Layers of MEDICAL IT-NETWORKS where
errors can be found
Annex D (informative) - Probability, severity, and RISK
acceptability scales used in the examples in this
technical report
Annex E (informative) - MONITORING RISK mitigation
effectiveness
Annex F (informative) - RISK ANALYZING small changes in a
MEDICAL IT-NETWORK
Annex G (informative) - Example of Change Window Form
Annex H (informative) - Template for examples
Bibliography
Gives step-by-step information to aid RESPONSIBLE ORGANIZATIONS in implementation of the RISK MANAGEMENT PROCESS required by IEC 80001-1.
| Document Type | Standard |
| Status | Current |
| Publisher | International Electrotechnical Committee |
| Committee | TC 62 |
