Already a subscriber?
MADCAD.com Free Trial
Sign up for a 3 day free trial to explore the MADCAD.com interface, PLUS access the
2009 International Building Code to see how it all works.
If you like to setup a quick demo, let us know at support@madcad.com
or +1 800.798.9296 and we will be happy to schedule a webinar for you.
Security check
Please login to your personal account to use this feature.
Please login to your authorized staff account to use this feature.
Are you sure you want to empty the cart?
18/30349190 DC BS ISO 81001-1. Health software and health IT systems safety, effectiveness and security - Part 1. Foundational principles, concepts, and terms, 2019
- 62A_1283e_CD.pdf [Go to Page]
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Symbols (and abbreviated terms)
- 5 Overarching themes [Go to Page]
- 5.1 General
- 5.2 Socio-Technical Ecosystem
- 5.3 System of systems
- 5.4 Lifecycle of a health IT system
- 5.5 Roles and responsibilities
- 5.6 Communication
- 5.7 Interdependence of safety, effectiveness and security
- 6 Foundational elements [Go to Page]
- 6.1 General
- 6.2 Governance (Internal organization focus) [Go to Page]
- 6.2.1 Organization leadership, culture and competence [Go to Page]
- 6.2.1.1 Statement
- 6.2.1.2 Rationale
- 6.2.1.3 Key concepts and Principles
- 6.2.1.4 Approach
- 6.2.2 Quality management and effectiveness [Go to Page]
- 6.2.2.1 Statement
- 6.2.2.2 Rationale
- 6.2.2.3 Key concepts and Principles
- 6.2.2.3.4 Key tenets of an effective quality management program include:
- 6.2.2.4 Approach
- 6.2.3 Information Governance [Go to Page]
- 6.2.3.1 Statement
- 6.2.3.2 Rationale
- 6.2.3.3 Key concepts and Principles
- 6.2.3.4 Approach
- 6.2.4 Human factors [Go to Page]
- 6.2.4.1 Statement
- 6.2.4.2 Rationale
- 6.2.4.3 Key concepts and Principles
- 6.2.4.4 Approach
- 6.3 Knowledge transfer (Cross organization collaboration) [Go to Page]
- 6.3.1 Risk management [Go to Page]
- 6.3.1.1 Statement
- 6.3.1.2 Rationale
- 6.3.1.3 Key concepts
- 6.3.1.4 Approach
- 6.3.2 Safety Management [Go to Page]
- 6.3.2.1 Statement
- 6.3.2.2 Rationale
- 6.3.2.3 Key concepts
- 6.3.2.4 Approach
- 6.3.3 Security Management [Go to Page]
- 6.3.3.1 Statement
- 6.3.3.2 Rationale
- 6.3.3.3 Key concepts
- 6.3.3.4 Approach
- 6.3.4 Privacy Management [Go to Page]
- 6.3.4.1 Statement
- 6.3.4.2 Rationale
- 6.3.4.3 Key concepts and principles
- 6.3.4.4 Approach
- Annex A (informative) Overview of clinical assurance case
- Annex B (informative) Overview of clinical assurance case report
- Annex C (informative) The clinical assurance report template
- Annex D (informative) Use of clinical assurance cases across the lifecycle
- Annex E (informative) Example assurance case
- 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
- 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/... [Go to Page]