{"id":401235,"date":"2024-10-20T04:55:23","date_gmt":"2024-10-20T04:55:23","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-2800-1-1-2022\/"},"modified":"2024-10-26T08:42:32","modified_gmt":"2024-10-26T08:42:32","slug":"aami-2800-1-1-2022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-2800-1-1-2022\/","title":{"rendered":"AAMI 2800 1 1 2022"},"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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/UL 2800-1-1:2022; Standard for Risk Concerns for Interoperable
\nMedical Products
\n <\/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 Page <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
7<\/td>\nAAMI Standard <\/td>\n<\/tr>\n
9<\/td>\nStandard for Risk Concerns for Interoperable Medical Products
1 Introduction <\/td>\n<\/tr>\n
10<\/td>\n2 Scope
3 Referenced Publications <\/td>\n<\/tr>\n
11<\/td>\n4 Terms and Definitions
5 Risk Concerns
5.1 General
5.2 Clinical properties
5.2.1 Semantic interoperability <\/td>\n<\/tr>\n
12<\/td>\n5.2.2 Patient identity
5.2.3 Operator identity, authentication, and authorization <\/td>\n<\/tr>\n
14<\/td>\n5.2.4 Interoperable item id, authentication, and authorization <\/td>\n<\/tr>\n
15<\/td>\n5.3 Engineering properties
5.3.1 Interoperability item connectivity <\/td>\n<\/tr>\n
16<\/td>\n5.3.2 Safe states
5.3.3 Time synchronization <\/td>\n<\/tr>\n
17<\/td>\n5.3.4 Shared resources, and data\/time partitioning <\/td>\n<\/tr>\n
18<\/td>\n5.4 Service properties
5.5 Security properties <\/td>\n<\/tr>\n
19<\/td>\nAnnex A (Informative) Interoperability Usability Concepts
A1 Overview <\/td>\n<\/tr>\n
20<\/td>\nA2 Recommendations <\/td>\n<\/tr>\n
23<\/td>\nAnnex B (Informative) Security Properties of Interoperable Medical Systems
B1 Security Elements of SSOs <\/td>\n<\/tr>\n
24<\/td>\nB2 Relationship to UL 2900 Series <\/td>\n<\/tr>\n
25<\/td>\nAnnex C (Informative) Clinical Properties of Interoperable Medical Systems
C1 Semantic Interoperability and Nomenclature
C1.1 Overview <\/td>\n<\/tr>\n
27<\/td>\nC1.2 Recommendations
C1.2.1 Interoperable item development <\/td>\n<\/tr>\n
28<\/td>\nC1.2.2 Interoperable item integration
C1.2.3 Interoperable medical system development
C1.2.4 Interoperability framework
C1.2.5 Supporting concepts <\/td>\n<\/tr>\n
29<\/td>\nC2 Patient Identity and Association
C2.1 Overview
C2.2 Recommendations
C2.2.1 Interoperable item development activities <\/td>\n<\/tr>\n
31<\/td>\nC2.2.2 Interoperable medical system development activities <\/td>\n<\/tr>\n
32<\/td>\nC3 Operator Identification, Authentication, and Authorization
C3.1 Overview
C3.2 Recommendations
C3.2.1 Interoperable item development <\/td>\n<\/tr>\n
34<\/td>\nC3.2.2 Interoperable item integration <\/td>\n<\/tr>\n
35<\/td>\nC3.2.3 Interoperable medical system development <\/td>\n<\/tr>\n
38<\/td>\nC3.2.4 Interoperability framework <\/td>\n<\/tr>\n
39<\/td>\nC4 Item Identification, Authentication, and Authorization
C4.1 Recommendations
C4.1.1 Interoperable item development activities <\/td>\n<\/tr>\n
40<\/td>\nC4.1.2 Interoperable item integration activities <\/td>\n<\/tr>\n
41<\/td>\nC4.1.3 Interoperable medical system development activities <\/td>\n<\/tr>\n
44<\/td>\nC4.1.4 Interoperability framework activities <\/td>\n<\/tr>\n
45<\/td>\nAnnex D (Informative) Engineering Properties of Interoperable Medical Systems
D1 Interoperable Item Connectivity
D1.1 Overview <\/td>\n<\/tr>\n
47<\/td>\nD1.2 Recommendations
D1.2.1 Interoperable item development <\/td>\n<\/tr>\n
48<\/td>\nD1.2.2 Interoperable item integration <\/td>\n<\/tr>\n
50<\/td>\nD2 Safe States
D2.1 Overview
D2.2 Recommendations <\/td>\n<\/tr>\n
51<\/td>\nD2.2.1 Interoperable item development
D2.2.2 Interoperable item integration
D2.2.3 Interoperable medical system development
D3 Time Synchronization
D3.1 Overview <\/td>\n<\/tr>\n
52<\/td>\nD3.2 Recommendations <\/td>\n<\/tr>\n
53<\/td>\nD4 Shared Resources and Data and Time Partitioning
D4.1 Overview
D4.2 Recommendations <\/td>\n<\/tr>\n
56<\/td>\nAnnex E (Informative) Services for Interoperable Medical Systems
E1 General
E1.1 Alarm system considerations
E1.2 Management of alarm conditions in an interoperable medical system <\/td>\n<\/tr>\n
57<\/td>\nE2 Alarm Signaling to Operator
E3 Alarm System Characteristics
E3.1 Logging <\/td>\n<\/tr>\n
58<\/td>\nE3.2 Acknowledgment
E3.3 Quality of service
E3.4 Intelligent alarm system
E4 Intelligent alarm system
E5 Interoperable Item Capabilities <\/td>\n<\/tr>\n
59<\/td>\nE6 Interoperable Medical System Maintenance and Diagnostics <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/UL 2800-1-1:2022, Standard for Risk Concerns for Interoperable Medical Products<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2022<\/td>\n59<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":401241,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-401235","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\/401235","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\/401241"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=401235"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=401235"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=401235"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}