AAMI/UL2800 1 2019
$239.06
ANSI/AAMI/UL 2800-1:2019 – Standard for Safety for Medical Device Interoperability
| Published By | Publication Date | Number of Pages |
| AAMI | 2019 | 180 |
Specifies a baseline set of requirements for assuring safe and secure interoperability for Interoperable Medical Systems.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/UL 2800-1:2019; Standard for Safety for Medical Device Interoperability |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | Commitment for Amendments Copyright information |
| 5 | Contents |
| 9 | Committee representation |
| 10 | AAMI Standard |
| 11 | 1 Introduction |
| 12 | 2 Scope 3 References |
| 13 | 4 Terms and Definitions |
| 26 | 5 (Leadership) Management Responsibility |
| 27 | 6 Interoperability Information |
| 29 | 7 Interoperability Management |
| 30 | Figure 7.1 INTEROPERABLE ENVIRONMENT ontology |
| 31 | Figure 7.2 Schematic of interoperability realization lifecycle |
| 32 | 8 Interoperability Realization Processes |
| 41 | 9 Design, Development and Implementation of Interoperability |
| 42 | Figure 9.1 Interoperability contexts of use |
| 49 | 10 Interoperability of EXTERNALLY SOURCED PRODUCTS |
| 51 | 11 Provisioning, Deployment, and Operation |
| 52 | 12 Testing and Review |
| 54 | 13 Traceability and Release |
| 55 | 14 Interoperability Performance Monitoring and Control of Changes |
| 57 | 15 Improvement of Processes |
| 58 | Annex A (Informative) Stakeholder Activities |
| 64 | Annex B (Informative) Guidance on Declaration of Products and Services Figure B1.1 Elements of interoperability ecosystem and key processes |
| 65 | Figure B1.2 Primary compliance relationships |
| 66 | Figure B1.3 Compliance relationships for primary topology categories |
| 69 | Annex C (Informative) Guidance on INTEROPERABILITY FILE |
| 70 | Table C1.1Work products |
| 84 | Annex D (Informative) Guidance on DISCLOSURE |
| 85 | Table D1.1 Disclosures |
| 86 | Annex E (Normative) Interoperability Realization Life-cycle ProcessE1 |
| 108 | Annex F (Informative) GUIDANCE ON RELEASE CRITERIA |
| 112 | Annex G (Informative) Testing Guidance |
| 118 | Annex H (Informative) RISK MANAGEMENT Guidance |
| 124 | Annex I (Informative) Common Fault Types |
| 125 | Annex J (Informative) Interoperability Usability Concepts |
| 128 | Annex K (Informative) SECURITY Principles |
| 130 | Annex L (Informative) Clinical Context Concepts |
| 133 | Annex M (Informative) Clinical Properties of INTEROPERABLE MEDICAL SYSTEMS |
| 152 | Annex N (Informative) Architecture Definition Guidance |
| 153 | Figure N1 Entity/relation diagram capturing the relationships between interoperable item, interoperablemedical system, item interoperability specification, interaction point, interoperable item boundary,and interoperability interface |
| 155 | Figure N2 Diagram capturing the relationships between interoperability architecture, variability,interoperability architecture configuration, and interoperability architecture instance |
| 162 | Annex O (Informative) INTEROPERABILITY ARCHITECTURE SPECIFICATION |
| 167 | Annex P (Informative) Engineering Properties of INTEROPERABLE MEDICAL SYSTEMS |
| 177 | Annex Q (Informative) Services for INTEROPERABLE MEDICAL SYSTEMS |
