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BS EN IEC 80001-1:2021 – TC

BS EN IEC 80001-1:2021 – TC

$217.84

Tracked Changes. Application of risk management for IT-networks incorporating medical devices – Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

Published By Publication Date Number of Pages
BSI 2021 124
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PDF Catalog

PDF Pages PDF Title
84 undefined
88 English
CONTENTS
90 FOREWORD
93 INTRODUCTION
94 Figure 1 – Lifecycle framework addressing safety, effectiveness and securityof health software and health IT systems
95 1 Scope
2 Normative references
3 Terms and definitions
96 4 Principles
97 5 Framework
5.1 General
5.2 Leadership and commitment
5.3 Integrating risk management
98 5.4 Design/planning
5.4.1 General
Figure 2 – Risk management process
99 5.4.2 RISK MANAGEMENT FILE
5.4.3 Understanding the organization and the sociotechnical ecosystem
5.4.4 Articulating risk management commitment
5.4.5 Assigning organizational roles, authorities, responsibilities and accountabilities
100 5.4.6 Allocating resources
5.4.7 Establishing communication and consultation
101 5.5 Implementation
5.6 Evaluation
5.7 Improvement
6 RISK MANAGEMENT PROCESS
6.1 Generic requirements
6.1.1 General
102 6.1.2 RISK ANALYSIS
104 6.1.3 RISK EVALUATION
105 6.1.4 RISK CONTROL
107 6.2 Lifecycle specific requirements
6.2.1 General
6.2.2 Acquisition
108 6.2.3 Installation, customization and configuration
6.2.4 Integration, data migration, transition and validation
6.2.5 Implementation, workflow optimization and training
109 6.2.6 Operation and maintenance
110 6.2.7 Decommission
111 Annex A (informative)IEC 80001-1 requirements mapping table
Tables
Table A.1 – IEC 80001-1 requirements table
117 Annex B (informative)Guidance for accompanying document Information
B.1 Foreword
Table B.1 – Organization name and location
118 B.2 Information system categorization
B.3 Overview
B.4 Reference documents
B.5 System level description
B.5.1 Environment description
Table B.2 – Cybersecurity device characterization level
119 B.5.2 Network ports, protocols and services
B.5.3 Purpose of connection to the health IT infrastructure
B.5.4 Networking requirements
B.5.5 Required IT-network services
B.5.6 Data flows and protocols
Table B.3 – Ports, protocols and services
120 B.6 Security and user access
B.6.1 General
B.6.2 Malware / antivirus / allow-list
B.6.3 Security exclusions
B.6.4 System access
Table B.4 – Information system name and title
121 Table B.5 – Roles and privileges
122 B.7 RISK MANAGEMENT
123 Bibliography

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BS EN IEC 80001-1:2021 - TC
$217.84