{"id":198147,"date":"2024-10-19T12:36:51","date_gmt":"2024-10-19T12:36:51","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir80001-2-5-2014\/"},"modified":"2024-10-25T05:10:02","modified_gmt":"2024-10-25T05:10:02","slug":"aami-tir80001-2-5-2014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir80001-2-5-2014\/","title":{"rendered":"AAMI TIR80001 2 5 2014"},"content":{"rendered":"

This Technical Report gives guidance and practical techniques for responsible organizations, medical device manufacturers and providers of other information technology in the application of IEC 80001-1:2010 for the risk management of distributed alarm systems. This Technical Report applies to the transmission of alarm conditions between sources, integrator and receivers where at least one source is a medical device and at least one communication path utilizes a medical IT-network. It provides recommendations for the integration, communication of responses and redirection (to another operator) of alarm conditions from one or more sources to ensure safety, effectiveness and data and systems security.<\/p>\n

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1<\/td>\nANSI\/AAMI\/IEC TIR80001-2-5:2014, Application of risk management for IT-networks incorporating medical devices \u2013 Part 2-5: Application guidance \u2013 Guidance on distributed alarm systems <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nCopyright information <\/td>\n<\/tr>\n
5<\/td>\nAAMI Technical Information Report
ANSI Technical Report <\/td>\n<\/tr>\n
6<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
8<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nBackground of AAMI adoption of IEC TR 80001-2-5 <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope <\/td>\n<\/tr>\n
15<\/td>\n2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
23<\/td>\n4 Functions of the distribution of alarm conditions
4.1 General
4.2 Sources and their alarm conditions <\/td>\n<\/tr>\n
24<\/td>\n4.3 Integrator
4.4 Communicator
4.5 Medical IT-network <\/td>\n<\/tr>\n
25<\/td>\n5 Types of systems for distributing alarm conditions
5.1 General
Table 1 \u2013 General comparison of system properties for ALARM CONDITION integration
5.2 Distributed information system about alarm conditions <\/td>\n<\/tr>\n
26<\/td>\n5.3 Distributed alarm system
5.4 Distributed alarm system with operator confirmation
6 Risk management
6.1 General explanation <\/td>\n<\/tr>\n
27<\/td>\n6.2 Determining the responsible organization\u2019s objective purpose
6.3 Hazards and hazardous situations related to dis, das and cdas <\/td>\n<\/tr>\n
28<\/td>\n6.4 Causes and resulting hazardous situations <\/td>\n<\/tr>\n
30<\/td>\n6.5 Risk control measures related to the integration of alarm conditions
6.5.1 Technical risk control measures implemented in equipment <\/td>\n<\/tr>\n
31<\/td>\n6.5.2 Typical risk control measures for implementation by the responsible organization <\/td>\n<\/tr>\n
33<\/td>\n6.5.3 Organizational policies and procedures as risk control measures for implementation by the responsible organization <\/td>\n<\/tr>\n
35<\/td>\nAnnex A: Correspondence between the risk control measures of this technical report and IEC 60601-1-8
Table A.1 \u2013 Correspondence of the technical RISK CONTROL measures of this technical report for a CDAS and IEC 60601-1-8 for a DAS <\/td>\n<\/tr>\n
37<\/td>\nAnnex B: Types of sources
B.1 Medical devices <\/td>\n<\/tr>\n
38<\/td>\nB.2 Nurse call system <\/td>\n<\/tr>\n
40<\/td>\nAnnex C: Applicability of types of system for the distribution of alarm conditions
Figure C.1 \u2013 Cascading structure of system for the distribution of ALARM CONDITIONS <\/td>\n<\/tr>\n
41<\/td>\nFigure C.2 \u2013 Example for INTEGRATOR of a PATIENT monitor with central monitoring station to distribute ALARM CONDITIONS in a physically isolated IT-NETWORK in a CDAS <\/td>\n<\/tr>\n
42<\/td>\nFigure C.3 \u2013 Example for INTEGRATOR of a PATIENT monitor to distribute ALARM CONDITIONS in a NURSE CALL SYSTEM, and via a PBX with handsets <\/td>\n<\/tr>\n
43<\/td>\nAnnex D: Scalability of types of system for the distribution of alarm conditions <\/td>\n<\/tr>\n
44<\/td>\nFigure D.1 \u2013 Example hospital-wide DISTRIBUTED ALARM SYSTEM <\/td>\n<\/tr>\n
45<\/td>\nBibliography <\/td>\n<\/tr>\n
46<\/td>\nIndex of defined terms used in this technical report <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/IEC TIR80001-2-5:2014 – Application of risk management for IT-networks incorporating medical devices-Part 2-5: Application guidance – Guidance for distributed alarm systems<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2014<\/td>\n47<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198151,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198147","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\/198147","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\/198151"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198147"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198147"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198147"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}