{"id":198371,"date":"2024-10-19T12:37:42","date_gmt":"2024-10-19T12:37:42","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-ul2800-1-2019\/"},"modified":"2024-10-25T05:10:45","modified_gmt":"2024-10-25T05:10:45","slug":"aami-ul2800-1-2019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-ul2800-1-2019\/","title":{"rendered":"AAMI\/UL2800 1 2019"},"content":{"rendered":"

Specifies a baseline set of requirements for assuring safe and secure interoperability for Interoperable Medical Systems.<\/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\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
1<\/td>\nANSI\/AAMI\/UL 2800-1:2019; Standard for Safety for Medical Device Interoperability <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and recommended practices <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nCommitment for Amendments
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
9<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nAAMI Standard <\/td>\n<\/tr>\n
11<\/td>\n1 Introduction <\/td>\n<\/tr>\n
12<\/td>\n2 Scope
3 References <\/td>\n<\/tr>\n
13<\/td>\n4 Terms and Definitions <\/td>\n<\/tr>\n
26<\/td>\n5 (Leadership) Management Responsibility <\/td>\n<\/tr>\n
27<\/td>\n6 Interoperability Information <\/td>\n<\/tr>\n
29<\/td>\n7 Interoperability Management <\/td>\n<\/tr>\n
30<\/td>\nFigure 7.1 INTEROPERABLE ENVIRONMENT ontology <\/td>\n<\/tr>\n
31<\/td>\nFigure 7.2 Schematic of interoperability realization lifecycle <\/td>\n<\/tr>\n
32<\/td>\n8 Interoperability Realization Processes <\/td>\n<\/tr>\n
41<\/td>\n9 Design, Development and Implementation of Interoperability <\/td>\n<\/tr>\n
42<\/td>\nFigure 9.1 Interoperability contexts of use <\/td>\n<\/tr>\n
49<\/td>\n10 Interoperability of EXTERNALLY SOURCED PRODUCTS <\/td>\n<\/tr>\n
51<\/td>\n11 Provisioning, Deployment, and Operation <\/td>\n<\/tr>\n
52<\/td>\n12 Testing and Review <\/td>\n<\/tr>\n
54<\/td>\n13 Traceability and Release <\/td>\n<\/tr>\n
55<\/td>\n14 Interoperability Performance Monitoring and Control of Changes <\/td>\n<\/tr>\n
57<\/td>\n15 Improvement of Processes <\/td>\n<\/tr>\n
58<\/td>\nAnnex A (Informative) Stakeholder Activities <\/td>\n<\/tr>\n
64<\/td>\nAnnex B (Informative) Guidance on Declaration of Products and Services
Figure B1.1 Elements of interoperability ecosystem and key processes <\/td>\n<\/tr>\n
65<\/td>\nFigure B1.2 Primary compliance relationships <\/td>\n<\/tr>\n
66<\/td>\nFigure B1.3 Compliance relationships for primary topology categories <\/td>\n<\/tr>\n
69<\/td>\nAnnex C (Informative) Guidance on INTEROPERABILITY FILE <\/td>\n<\/tr>\n
70<\/td>\nTable C1.1Work products <\/td>\n<\/tr>\n
84<\/td>\nAnnex D (Informative) Guidance on DISCLOSURE <\/td>\n<\/tr>\n
85<\/td>\nTable D1.1 Disclosures <\/td>\n<\/tr>\n
86<\/td>\nAnnex E (Normative) Interoperability Realization Life-cycle ProcessE1 <\/td>\n<\/tr>\n
108<\/td>\nAnnex F (Informative) GUIDANCE ON RELEASE CRITERIA <\/td>\n<\/tr>\n
112<\/td>\nAnnex G (Informative) Testing Guidance <\/td>\n<\/tr>\n
118<\/td>\nAnnex H (Informative) RISK MANAGEMENT Guidance <\/td>\n<\/tr>\n
124<\/td>\nAnnex I (Informative) Common Fault Types <\/td>\n<\/tr>\n
125<\/td>\nAnnex J (Informative) Interoperability Usability Concepts <\/td>\n<\/tr>\n
128<\/td>\nAnnex K (Informative) SECURITY Principles <\/td>\n<\/tr>\n
130<\/td>\nAnnex L (Informative) Clinical Context Concepts <\/td>\n<\/tr>\n
133<\/td>\nAnnex M (Informative) Clinical Properties of INTEROPERABLE MEDICAL SYSTEMS <\/td>\n<\/tr>\n
152<\/td>\nAnnex N (Informative) Architecture Definition Guidance <\/td>\n<\/tr>\n
153<\/td>\nFigure N1 Entity\/relation diagram capturing the relationships between interoperable item, interoperablemedical system, item interoperability specification, interaction point, interoperable item boundary,and interoperability interface <\/td>\n<\/tr>\n
155<\/td>\nFigure N2 Diagram capturing the relationships between interoperability architecture, variability,interoperability architecture configuration, and interoperability architecture instance <\/td>\n<\/tr>\n
162<\/td>\nAnnex O (Informative) INTEROPERABILITY ARCHITECTURE SPECIFICATION <\/td>\n<\/tr>\n
167<\/td>\nAnnex P (Informative) Engineering Properties of INTEROPERABLE MEDICAL SYSTEMS <\/td>\n<\/tr>\n
177<\/td>\nAnnex Q (Informative) Services for INTEROPERABLE MEDICAL SYSTEMS <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/UL 2800-1:2019 – Standard for Safety for Medical Device Interoperability<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2019<\/td>\n180<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198378,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198371","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/198371","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\/198378"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198371"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198371"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198371"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}