{"id":385141,"date":"2024-10-20T03:29:17","date_gmt":"2024-10-20T03:29:17","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iec-80001-12021\/"},"modified":"2024-10-26T06:19:23","modified_gmt":"2024-10-26T06:19:23","slug":"bs-en-iec-80001-12021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iec-80001-12021\/","title":{"rendered":"BS EN IEC 80001-1:2021"},"content":{"rendered":"

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

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
6<\/td>\nEnglish
CONTENTS <\/td>\n<\/tr>\n
8<\/td>\nFOREWORD <\/td>\n<\/tr>\n
11<\/td>\nINTRODUCTION <\/td>\n<\/tr>\n
12<\/td>\nFigure 1 \u2013 Lifecycle framework addressing safety, effectiveness and securityof health software and health IT systems <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
14<\/td>\n4 Principles <\/td>\n<\/tr>\n
15<\/td>\n5 Framework
5.1 General
5.2 Leadership and commitment
5.3 Integrating risk management <\/td>\n<\/tr>\n
16<\/td>\n5.4 Design\/planning
5.4.1 General
Figure 2 \u2013 Risk management process <\/td>\n<\/tr>\n
17<\/td>\n5.4.2 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 <\/td>\n<\/tr>\n
18<\/td>\n5.4.6 Allocating resources
5.4.7 Establishing communication and consultation <\/td>\n<\/tr>\n
19<\/td>\n5.5 Implementation
5.6 Evaluation
5.7 Improvement
6 RISK MANAGEMENT PROCESS
6.1 Generic requirements
6.1.1 General <\/td>\n<\/tr>\n
20<\/td>\n6.1.2 RISK ANALYSIS <\/td>\n<\/tr>\n
22<\/td>\n6.1.3 RISK EVALUATION <\/td>\n<\/tr>\n
23<\/td>\n6.1.4 RISK CONTROL <\/td>\n<\/tr>\n
25<\/td>\n6.2 Lifecycle specific requirements
6.2.1 General
6.2.2 Acquisition <\/td>\n<\/tr>\n
26<\/td>\n6.2.3 Installation, customization and configuration
6.2.4 Integration, data migration, transition and validation
6.2.5 Implementation, workflow optimization and training <\/td>\n<\/tr>\n
27<\/td>\n6.2.6 Operation and maintenance <\/td>\n<\/tr>\n
28<\/td>\n6.2.7 Decommission <\/td>\n<\/tr>\n
29<\/td>\nAnnex A (informative)IEC 80001-1 requirements mapping table
Tables
Table A.1 \u2013 IEC 80001-1 requirements table <\/td>\n<\/tr>\n
35<\/td>\nAnnex B (informative)Guidance for accompanying document Information
B.1 Foreword
Table B.1 \u2013 Organization name and location <\/td>\n<\/tr>\n
36<\/td>\nB.2 Information system categorization
B.3 Overview
B.4 Reference documents
B.5 System level description
B.5.1 Environment description
Table B.2 \u2013 Cybersecurity device characterization level <\/td>\n<\/tr>\n
37<\/td>\nB.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 \u2013 Ports, protocols and services <\/td>\n<\/tr>\n
38<\/td>\nB.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 \u2013 Information system name and title <\/td>\n<\/tr>\n
39<\/td>\nTable B.5 \u2013 Roles and privileges <\/td>\n<\/tr>\n
40<\/td>\nB.7 RISK MANAGEMENT <\/td>\n<\/tr>\n
41<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

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<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2021<\/td>\n42<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":385148,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[704,2641],"product_tag":[],"class_list":{"0":"post-385141","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-35-240-80","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/385141","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/385148"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=385141"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=385141"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=385141"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}