{"id":374178,"date":"2024-10-20T02:37:21","date_gmt":"2024-10-20T02:37:21","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-mp80601-249-2020\/"},"modified":"2024-10-26T04:35:01","modified_gmt":"2024-10-26T04:35:01","slug":"aami-mp80601-249-2020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-mp80601-249-2020\/","title":{"rendered":"AAMI MP80601 249 2020"},"content":{"rendered":"

This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of MULTIFUNCTION PATIENT MONITORS. It amends and supplements IEC 60601-1:2005 and IEC 606011:2005\/AMD1:2012, Medical electrical equipment \u2013 Part 1: General requirements for basic safety and essential performance<\/p>\n

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1<\/td>\nANSI\/AAMI MP80601-2-49:2020 (IEC 80601-2-49:2020, MOD) Medical electrical equipment\u2014Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors <\/td>\n<\/tr>\n
2<\/td>\nBlank Page <\/td>\n<\/tr>\n
3<\/td>\nTitle Page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard <\/td>\n<\/tr>\n
5<\/td>\nContents Page <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nBackground of ANSI\/AAMI adoption of IEC 80601-2-49:2018 with deviations <\/td>\n<\/tr>\n
9<\/td>\nU.S. Deviations to IEC 80601-2-49:2018 <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n201.1 Scope, object and related standards
201.1.1 * Scope <\/td>\n<\/tr>\n
16<\/td>\n201.1.2 Object
201.1.3 Collateral standards
201.1.4 Particular standards <\/td>\n<\/tr>\n
17<\/td>\n201.2 Normative references <\/td>\n<\/tr>\n
18<\/td>\n201.3 Terms and definitions
201.4 General requirements
201.4.3 Essential performance
201.4.3.101 Additional essential performance requirements <\/td>\n<\/tr>\n
19<\/td>\nTable 201.101 \u2013 ESSENTIAL PERFORMANCE requirements
201.4.5 * Alternative risk control measures or test methods for me equipment or me systems
201.5 General requirements for testing me equipment
201.5.4 Other conditions
201.6 Classification of me equipment and me systems <\/td>\n<\/tr>\n
20<\/td>\n201.6.2 * Protection against electric shock
201.6. 6 Mode of operation
201.7 Me equipment identification, marking and documents
201.7.2 Marking on the outside of me equipment or me equipment parts
201.7.2.101 Connectors for applied parts
201.7.9.2.2 Warning and safety notices
201.7.9.2.9 Operating instructions
201.7.9.2.9.101 Additional instructions for use <\/td>\n<\/tr>\n
21<\/td>\n201.8 Protection against electrical hazards from me equipment
201.8.3 Classification of applied parts
201.8.5.2.3 * Patient leads or patient cables <\/td>\n<\/tr>\n
22<\/td>\nFigure 201.101 \u2013 MULTIFUNCTION PATIENT MONITOR with single PATIENT circuit (6) with multiple PHYSIOLOGICAL MONITORING UNITS and multiple PATIENT circuits (7) each with a single PHYSIOLOGICAL MONITORING UNIT <\/td>\n<\/tr>\n
23<\/td>\n201.8.5.5.1 * Defibrillation protection
201.9 Protection against mechanical hazards of me equipment and me systems
201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
201.11.6.5 * Ingress of water or particulate matter into me equipment and me systems <\/td>\n<\/tr>\n
24<\/td>\n201.11. 8 * Interruption of the power supply \/ supply mains to me equipment
201.11.8.101 Protection against depletion of the internal electrical power source <\/td>\n<\/tr>\n
25<\/td>\n201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.12. 3 Alarm systems
201.13 Hazardous situations and fault conditions for me equipment
201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
201.15.1 Arrangements of controls and indicators of ME EQUIPMENT
201.15.101 Display of patient data
201.15.102 Units of measurement
201.15.4.4 Indicators <\/td>\n<\/tr>\n
26<\/td>\n201.15.4.4.101 Indicator of operation from the internal electrical power source and the status of the internal electrical power source
201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
202 Electromagnetic disturbances \u2013 Requirements and tests
202.7 Electromagnetic emissions requirements for me equipment and me systems
202.7.1 Protection of radio services and other equipment
202.7.1.101 * Emissions test setup <\/td>\n<\/tr>\n
27<\/td>\nFigure 202.101 \u2013 Test layout for conducted and radiated EMISSIONS and IMMUNITY test(see 202.7.1.101 and 202.8.101)
202.8.1 General <\/td>\n<\/tr>\n
28<\/td>\n202.8.101 * Immunity test setup
202.8.102 * Disturbances from hf surgical equipment <\/td>\n<\/tr>\n
29<\/td>\nFigure 202.102 \u2013 Test circuit for HF SURGICAL EQUIPMENT protection measurement according to 202.8.102 with PATIENT CONNECTIONS <\/td>\n<\/tr>\n
30<\/td>\nFigure 202.103 \u2013 Test setup for HF SURGICAL EQUIPMENT protection measurement according to 202.8.102 <\/td>\n<\/tr>\n
31<\/td>\nFigure 202.104 \u2013 Test circuit for HF SURGICAL EQUIPMENT protection measurement according to 202.8.102 with non-conductive APPLIED PART
206 Usability
206.101 Primary operating functions <\/td>\n<\/tr>\n
32<\/td>\n208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
208.6.1.2 * Determination of alarm conditions and assignment of priority
208.6.3.2 Visual alarm signals
208.6.3.2.101 * Indication of validity of measured values
208.6.5 Alarm presets <\/td>\n<\/tr>\n
33<\/td>\n208.6.8 Alarm signal inactivation states
208.6.8.1 * General
208.6.10 * Non-latching and latching alarm signals
208.6.10.101 * Non-latching alarm signals for technical alarm conditions <\/td>\n<\/tr>\n
34<\/td>\n208.6.11.1 Existence of distributed alarm system
208.6.12 alarm system logging <\/td>\n<\/tr>\n
35<\/td>\nAnnexes <\/td>\n<\/tr>\n
36<\/td>\nAnnex AA (informative) Particular guidance and rationale
AA.1 Rationale and background
AA.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n
37<\/td>\nFigure AA.1 \u2013 Example of a pre-configured MULTIFUNCTION PATIENT MONITOR
Figure AA.2 \u2013 Example of a modular MULTIFUNCTION PATIENT MONITOR <\/td>\n<\/tr>\n
38<\/td>\nFigure AA.3 \u2013 Example of a MULTIFUNCTION PATIENT MONITOR connected to a central station
Figure AA.4 \u2013 Example of a MULTIFUNCTION PATIENT MONITOR integrated into a ventilator <\/td>\n<\/tr>\n
40<\/td>\nFigure AA.5 \u2013 Single PATIENT circuit with multiple PHYSIOLOGICAL MONITORING UNITS and PATIENT cables <\/td>\n<\/tr>\n
44<\/td>\nBibliography <\/td>\n<\/tr>\n
45<\/td>\nIndex of defined terms used in this particular standard <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI MP80601-249:2020 (IEC 80601-2-49:2020, MOD), Medical electrical equipment-Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2020<\/td>\n47<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":374183,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-374178","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\/374178","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\/374183"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=374178"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=374178"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=374178"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}