{"id":401240,"date":"2024-10-20T04:55:24","date_gmt":"2024-10-20T04:55:24","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-2800-1-2022\/"},"modified":"2024-10-26T08:42:35","modified_gmt":"2024-10-26T08:42:35","slug":"aami-2800-1-2022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-2800-1-2022\/","title":{"rendered":"AAMI 2800 1 2022"},"content":{"rendered":"
Specifies a baseline set of requirements for assuring safe and secure interoperability for Interoperable Medical Systems.<\/p>\n
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
1<\/td>\n | ANSI\/AAMI\/UL 2800-1:2022; Standard for Medical Device Interoperability <\/td>\n<\/tr>\n | ||||||
3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
4<\/td>\n | Commitment for Amendments Copyright information <\/td>\n<\/tr>\n | ||||||
5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | AAMI Standard <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | Standard for Safety for Medical Device Interoperability 1 Introduction <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | 2 Scope 3 References <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | 4 Terms and Definitions <\/td>\n<\/tr>\n | ||||||
24<\/td>\n | 5 (Leadership) Management Responsibility <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | 6 Interoperability Information <\/td>\n<\/tr>\n | ||||||
27<\/td>\n | 7 Interoperability Management <\/td>\n<\/tr>\n | ||||||
30<\/td>\n | 8 Interoperability Realization Processes <\/td>\n<\/tr>\n | ||||||
32<\/td>\n | 9 Design, Development, and Implementation of Interoperability <\/td>\n<\/tr>\n | ||||||
41<\/td>\n | 10 Interoperability of Externally Sourced Products <\/td>\n<\/tr>\n | ||||||
42<\/td>\n | 11 Provisioning, Deployment, and Operation <\/td>\n<\/tr>\n | ||||||
44<\/td>\n | 12 Testing and Review <\/td>\n<\/tr>\n | ||||||
46<\/td>\n | 13 Traceability and Release <\/td>\n<\/tr>\n | ||||||
47<\/td>\n | 14 Interoperability Performance Monitoring and Control of Changes <\/td>\n<\/tr>\n | ||||||
50<\/td>\n | Annex A (Informative) Stakeholder Activities <\/td>\n<\/tr>\n | ||||||
57<\/td>\n | Annex B (Informative) Guidance on Declaration of Products and Services <\/td>\n<\/tr>\n | ||||||
63<\/td>\n | Annex C (Informative) Clinical Context Concepts <\/td>\n<\/tr>\n | ||||||
67<\/td>\n | Annex D (Informative) Risk Management Guidance <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI\/UL 2800-1:2022, Standard for Medical Device Interoperability<\/b><\/p>\n |