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BS EN IEC 80001-1:2021

BS EN IEC 80001-1:2021

$167.15

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 42
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This document specifies general requirements for organizations in the application of risk management before, during and after the connection of a health it system within a health it infrastructure, by addressing the key properties of safety, effectiveness and security whilst engaging appropriate stakeholders.

PDF Catalog

PDF Pages PDF Title
2 undefined
6 English
CONTENTS
8 FOREWORD
11 INTRODUCTION
12 Figure 1 – Lifecycle framework addressing safety, effectiveness and securityof health software and health IT systems
13 1 Scope
2 Normative references
3 Terms and definitions
14 4 Principles
15 5 Framework
5.1 General
5.2 Leadership and commitment
5.3 Integrating risk management
16 5.4 Design/planning
5.4.1 General
Figure 2 – Risk management process
17 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
18 5.4.6 Allocating resources
5.4.7 Establishing communication and consultation
19 5.5 Implementation
5.6 Evaluation
5.7 Improvement
6 RISK MANAGEMENT PROCESS
6.1 Generic requirements
6.1.1 General
20 6.1.2 RISK ANALYSIS
22 6.1.3 RISK EVALUATION
23 6.1.4 RISK CONTROL
25 6.2 Lifecycle specific requirements
6.2.1 General
6.2.2 Acquisition
26 6.2.3 Installation, customization and configuration
6.2.4 Integration, data migration, transition and validation
6.2.5 Implementation, workflow optimization and training
27 6.2.6 Operation and maintenance
28 6.2.7 Decommission
29 Annex A (informative)IEC 80001-1 requirements mapping table
Tables
Table A.1 – IEC 80001-1 requirements table
35 Annex B (informative)Guidance for accompanying document Information
B.1 Foreword
Table B.1 – Organization name and location
36 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
37 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
38 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
39 Table B.5 – Roles and privileges
40 B.7 RISK MANAGEMENT
41 Bibliography

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BS EN IEC 80001-1:2021
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