🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BSI 18/30349190 DC:2019 Edition

BSI 18/30349190 DC:2019 Edition

$13.70

BS ISO 81001-1. Health software and health IT systems safety, effectiveness and security – Part 1. Foundational principles, concepts, and terms

Published By Publication Date Number of Pages
BSI 2019 55
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

PDF Catalog

PDF Pages PDF Title
12 1 Scope
13 2 Normative references
3 Terms and definitions
21 4 Symbols (and abbreviated terms)
5 Overarching themes
5.1 General
22 5.2 Socio-Technical Ecosystem
23 5.3 System of systems
5.4 Lifecycle of a health IT system
25 5.5 Roles and responsibilities
27 5.6 Communication
29 5.7 Interdependence of safety, effectiveness and security
6 Foundational elements
6.1 General
30 6.2 Governance (Internal organization focus)
6.2.1 Organization leadership, culture and competence
6.2.1.1 Statement
6.2.1.2 Rationale
31 6.2.1.3 Key concepts and Principles
32 6.2.1.4 Approach
6.2.2 Quality management and effectiveness
6.2.2.1 Statement
6.2.2.2 Rationale
6.2.2.3 Key concepts and Principles
33 6.2.2.3.4 Key tenets of an effective quality management program include:
6.2.2.4 Approach
6.2.3 Information Governance
6.2.3.1 Statement
6.2.3.2 Rationale
34 6.2.3.3 Key concepts and Principles
6.2.3.4 Approach
35 6.2.4 Human factors
6.2.4.1 Statement
6.2.4.2 Rationale
6.2.4.3 Key concepts and Principles
36 6.2.4.4 Approach
37 6.3 Knowledge transfer (Cross organization collaboration)
6.3.1 Risk management
6.3.1.1 Statement
6.3.1.2 Rationale
6.3.1.3 Key concepts
38 6.3.1.4 Approach
6.3.2 Safety Management
6.3.2.1 Statement
39 6.3.2.2 Rationale
6.3.2.3 Key concepts
6.3.2.4 Approach
40 6.3.3 Security Management
6.3.3.1 Statement
6.3.3.2 Rationale
6.3.3.3 Key concepts
41 6.3.3.4 Approach
42 6.3.4 Privacy Management
6.3.4.1 Statement
6.3.4.2 Rationale
6.3.4.3 Key concepts and principles
43 6.3.4.4 Approach
45 Annex A (informative) Overview of clinical assurance case
47 Annex B (informative) Overview of clinical assurance case report
50 Annex C (informative) The clinical assurance report template
52 Annex D (informative) Use of clinical assurance cases across the lifecycle
53 Annex E (informative) Example assurance case
54 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 — Part 1: Roles, responsibilities and activities
3. IEC/TR 80001-2-2:2012, Application of risk management for IT-networks incorporating medical devices — 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 — Part 2-3: Guidance for wireless networks
5. ISO/IEC Guide 51:2014, Safety aspects — Guidelines for their inclusion in standards
6. ISO/IEC Guide 63:20XX, Guide to the development and inclusion of aspects of safety in International Standards for medical devices
7. ISO 31 (all parts), Quantities and units
8. ISO 690, Documentation — Bibliographic references — Content, form and structure
9. ISO 690-2, Information and documentation — Bibliographic references — Part 2: Electronic documents or parts thereof
10. ISO 128-30, Technical drawings — General principles of presentation — Part 30: Basic conventions for views
11. ISO 128-34, Technical drawings — General principles of presentation — Part 34: Views on mechanical engineering drawings
12. ISO 128-40, Technical drawings — General principles of presentation — Part 40: Basic conventions for cuts and sections
13. ISO 128-44, Technical drawings — General principles of presentation — Part 44: Sections on mechanical engineering drawings
14. ISO 1000, SI units and recommendations for the use of their multiples and of certain other units
15. ISO 10241, International terminology standards — Preparation and layout
16. ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
17. ISO/IEC TR 10000-1, Information technology — Framework and taxonomy of International Standardized Profiles — Part 1: General principles and documentation framework
18. ISO 14971:2007, Medical devices — Application of risk management to medical devices
19. ISO 14971:20XX, Medical devices — Application of risk management to medical devices
20. ISO/IEC 20000-1:2005, Information technology — Service management — Part 1: Specification
55 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.uk/…

Related products

BSI 18/30349190 DC
$13.70