{"id":350439,"date":"2024-10-20T00:42:19","date_gmt":"2024-10-20T00:42:19","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-19-30381225-dc\/"},"modified":"2024-10-26T00:29:15","modified_gmt":"2024-10-26T00:29:15","slug":"bsi-19-30381225-dc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-19-30381225-dc\/","title":{"rendered":"BSI 19\/30381225 DC"},"content":{"rendered":"

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\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
11<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
12<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
23<\/td>\n4 Symbols (and abbreviated terms)
5 Core themes
5.1 General <\/td>\n<\/tr>\n
24<\/td>\n5.2 Socio-Technical Ecosystem <\/td>\n<\/tr>\n
25<\/td>\n5.3 System of systems <\/td>\n<\/tr>\n
26<\/td>\n5.4 Life cycle of a health IT system <\/td>\n<\/tr>\n
28<\/td>\n5.5 Roles and responsibilities <\/td>\n<\/tr>\n
29<\/td>\n5.6 Communication <\/td>\n<\/tr>\n
31<\/td>\n5.7 Interdependence of safety, effectiveness and security
6 Foundational elements
6.1 General <\/td>\n<\/tr>\n
33<\/td>\n6.2 Governance (intra organization focus)
6.2.1 Organization leadership, culture and competence
6.2.1.1 Statement
6.2.1.2 Rationale
6.2.1.3 Key concepts and principles <\/td>\n<\/tr>\n
34<\/td>\n6.2.1.4 Approach
6.2.2 Quality management
6.2.2.1 Statement <\/td>\n<\/tr>\n
35<\/td>\n6.2.2.2 Rationale
6.2.2.3 Key concepts and Principles
6.2.2.4 Approach <\/td>\n<\/tr>\n
36<\/td>\n6.2.3 Information Management
6.2.3.1 Statement
6.2.3.2 Rationale
6.2.3.3 Key concepts and Principles <\/td>\n<\/tr>\n
37<\/td>\n6.2.3.4 Approach
6.2.4 Human factors and Usability
6.2.4.1 Statement
6.2.4.2 Rationale
6.2.4.3 Key concepts and Principles <\/td>\n<\/tr>\n
38<\/td>\n6.2.4.4 Approach <\/td>\n<\/tr>\n
39<\/td>\n6.3 Knowledge transfer (inter and intra organization collaboration)
6.3.1 Risk management
6.3.1.1 Statement
6.3.1.2 Rationale
6.3.1.3 Key concepts <\/td>\n<\/tr>\n
40<\/td>\n6.3.1.4 Approach <\/td>\n<\/tr>\n
41<\/td>\n6.3.1.5 Knowledge transfer (communication)
6.3.1.6 Information sharing at major transition points (pre-implementation)
6.3.1.7 Ongoing cross-functional information sharing <\/td>\n<\/tr>\n
42<\/td>\n6.3.2 Safety management
6.3.2.1 Statement
6.3.2.2 Rationale
6.3.2.3 Key concepts <\/td>\n<\/tr>\n
43<\/td>\n6.3.2.4 Approach
6.3.2.5 Knowledge Transfer <\/td>\n<\/tr>\n
44<\/td>\n6.3.2.6 Information sharing at major transition points (pre-implementation)
6.3.2.7 Ongoing Cross-Functional Information sharing <\/td>\n<\/tr>\n
45<\/td>\n6.3.3 Security management
6.3.3.1 Statement
6.3.3.2 Rationale
6.3.3.3 Key concepts <\/td>\n<\/tr>\n
46<\/td>\n6.3.3.4 Approach
6.3.3.5 Knowledge transfer <\/td>\n<\/tr>\n
47<\/td>\n6.3.3.6 Information sharing at major transition points (pre-implementation)
6.3.3.7 Ongoing cross-functional information sharing
6.3.4 Privacy management
6.3.4.1 Statement
6.3.4.2 Rationale <\/td>\n<\/tr>\n
48<\/td>\n6.3.4.3 Key concepts and principles <\/td>\n<\/tr>\n
49<\/td>\n6.3.4.4 Approach
6.3.4.5 Knowledge transfer (Communication)
6.3.4.6 Information sharing at major transition points (pre-implementation)
6.3.4.7 Ongoing cross-functional information sharing <\/td>\n<\/tr>\n
50<\/td>\nAnnex A (informative) Particular guidance and rationale <\/td>\n<\/tr>\n
53<\/td>\nAnnex B (informative) Concept diagrams <\/td>\n<\/tr>\n
55<\/td>\nAnnex C (informative) Use of assurance cases for knowledge transfer <\/td>\n<\/tr>\n
59<\/td>\nNOTE TO REVIEWERS: This section is a placeholder for an example assurance case <\/td>\n<\/tr>\n
60<\/td>\n(1) IEC 60027 (all parts), Letter symbols to be used in electrical technology
(2) IEC 80001-1:2010, Application of risk management for IT-networks incorporating medical devices \u2014 Part 1: Roles, responsibilities and activities
(3) IEC\/TR 80001-2-2:2012, Application of risk management for IT-networks incorporating medical devices \u2014 Part 2-2: Guidance for the communication of medical device security needs, risks and controls
(4) IEC\/TR 80001-2-3:2012, Application of risk management for IT-networks incorporating medical devices \u2014 Part 2-3: Guidance for wireless networks
(5) IEC 60601 Technical standards for the safety and essential performance of medical electrical equipment
(6) ISO\/IEC Guide 51:2014, Safety aspects \u2014 Guidelines for their inclusion in standards
(7) ISO\/IEC Guide 63:2018, Guide to the development and inclusion of aspects of safety in International Standards for medical devices
(8) ISO 31 (all parts), Quantities and units
(9) ISO 690, Documentation \u2014 Bibliographic references \u2014 Content, form and structure
(10) ISO 690-2, Information and documentation \u2014 Bibliographic references \u2014 Part 2: Electronic documents or parts thereof
(11) ISO 128-30, Technical drawings \u2014 General principles of presentation \u2014 Part 30: Basic conventions for views
(12) ISO 128-34, Technical drawings \u2014 General principles of presentation \u2014 Part 34: Views on mechanical engineering drawings
(13) ISO 128-40, Technical drawings \u2014 General principles of presentation \u2014 Part 40: Basic conventions for cuts and sections
(14) ISO 128-44, Technical drawings \u2014 General principles of presentation \u2014 Part 44: Sections on mechanical engineering drawings
(15) ISO 1000, SI units and recommendations for the use of their multiples and of certain other units
(16) ISO 10241, International terminology standards \u2014 Preparation and layout
(17) ISO 9000:2015, Quality management systems \u2014 Fundamentals and vocabulary
(18) ISO\/IEC TR 10000-1, Information technology \u2014 Framework and taxonomy of International Standardized Profiles \u2014 Part 1: General principles and documentation framework
(19) ISO 14971:2007, Medical devices \u2014 Application of risk management to medical devices
(20) ISO\/IEC 20000-1:2005, Information technology — Service management — Part 1: Specification <\/td>\n<\/tr>\n
61<\/td>\n(21) ISO 27799:2016, Health informatics — Information security management in health using ISO\/IEC 27002
(22) ISO 31000,2018, Risk management
(23) ISB 0160, F. Brindley, J. Fox, S. White, Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems – Implementation Guidance, UK National Health Service: 2013 (Available at: http:\/\/webarchive.nationalarchives.gov.u…
(24) ISO TS 20405:2018, Health informatics \u2013 Framework of event data and reporting definitions for the safety of health software
(25) Neily J, Mills PD, Young-Xu Y, et al. Association between implementation of a medical team training program and surgical mortality. JAMA. 2010;304:1693-1700 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

BS ISO 81001-1. Health software and health IT systems safety, effectiveness and security. Foundational principles, concepts, and terms<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2019<\/td>\n61<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":350446,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[704,2641],"product_tag":[],"class_list":{"0":"post-350439","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\/350439","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\/350446"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=350439"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=350439"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=350439"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}