{"id":198227,"date":"2024-10-19T12:37:09","date_gmt":"2024-10-19T12:37:09","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-60601-2-27-2011-ra-2016\/"},"modified":"2024-10-25T05:10:17","modified_gmt":"2024-10-25T05:10:17","slug":"aami-60601-2-27-2011-ra-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-60601-2-27-2011-ra-2016\/","title":{"rendered":"AAMI 60601 2 27 2011 RA 2016"},"content":{"rendered":"

This standard specifies basic safety requirements and essential performance for electrocardiographic (ECG) monitoring equipment. It is applicable to ECG monitoring equipment used in a hospital environment. If it is used outside the hospital environment, such as in ambulances and air transport, the ECG monitoring equipment shall comply with this standard. This standard is not applicable to electrocardiographic monitors for home use and ECG telemetry systems. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use\/intended purpose. Ambulatory (“Holter”) monitors, fetal heart rate monitors, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nTitle page
\n <\/td>\n<\/tr>\n
3<\/td>\nAAMI Standard
Copyright page
\n <\/td>\n<\/tr>\n
4<\/td>\nContents
\n <\/td>\n<\/tr>\n
6<\/td>\nGlossary of equivalent standards
\n <\/td>\n<\/tr>\n
8<\/td>\nCommittee representation
\n <\/td>\n<\/tr>\n
9<\/td>\nBackground of ANSI\/AAMI adoption of IEC 60601-2-27:2011
\n <\/td>\n<\/tr>\n
10<\/td>\nForeword
\n <\/td>\n<\/tr>\n
12<\/td>\nIntroduction
\n <\/td>\n<\/tr>\n
14<\/td>\n201.1 Scope, object and related standards
\n
201.1.1
\nScope
201.1.2 Object
\n
201.1.3
\nCollateral standards <\/td>\n<\/tr>\n
15<\/td>\n201.1.4 Particular standards
\n <\/td>\n<\/tr>\n
16<\/td>\n201.2 Normative references
201.3 Terms and definitions <\/td>\n<\/tr>\n
18<\/td>\n201.4 General requirements
201.4. 3 Essential performance
201.4. 3.101 Additional essential performance requirements <\/td>\n<\/tr>\n
19<\/td>\n201.5 General requirements for testing of me\u00a0equipment
201.5. 4 Other conditions
201.5. 8 *Sequence of tests
201.6 Classification of me\u00a0equipment and me\u00a0systems
201.6. 2 *Protection against electric shock <\/td>\n<\/tr>\n
20<\/td>\n201.6. 6 Mode of operation
201.7 Me\u00a0equipment identification, marking and documents
201.7. 2.4 Accessories
201.7. 2.4.101 Marking of lead\u00a0wires <\/td>\n<\/tr>\n
21<\/td>\n201.7. 9.2.9 Operating instructions
201.7. 9.2.9.101 Additional instructions for use <\/td>\n<\/tr>\n
25<\/td>\n201.8 Protection against electrical hazards from me\u00a0equipment
201.8. 3 Classification of applied parts
201.8. 5.2.3 *\u00a0Patient leads
201.8. 5.5 Defibrillation-proof applied parts
201.8. 5.5.1 *\u00a0Defibrillation protection <\/td>\n<\/tr>\n
29<\/td>\n201.8.5.5.2 Energy reduction test <\/td>\n<\/tr>\n
30<\/td>\n201.9 Protection against mechanical hazards of me\u00a0equipment and me\u00a0systems
201.10 Protection against unwanted and excessive radiation hazards <\/td>\n<\/tr>\n
31<\/td>\n201.11 Protection against excessive temperatures and other hazards
201.11. 6.5 *\u00a0Ingress of water or particulate matter into me\u00a0equipment and me\u00a0systems
201.11. 8 *\u00a0Interruption of the power supply \/ supply mains to me\u00a0equipment <\/td>\n<\/tr>\n
32<\/td>\n201.11. 8.101 *\u00a0Protection against depletion of battery <\/td>\n<\/tr>\n
33<\/td>\n201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.12. 1 Accuracy of controls and instruments
201.12. 1.101 *\u00a0Essential performance of me\u00a0equipment
201.12.1.101.1 Accuracy of signal reproduction
\n <\/td>\n<\/tr>\n
35<\/td>\n201.12. 1.101.2 *\u00a0Input dynamic range and differential offset voltage
201.12. 1.101.3 *\u00a0Input impedance
201.12. 1.101.4 Input noise <\/td>\n<\/tr>\n
36<\/td>\n201.12. 1.101.5 Multichannel crosstalk <\/td>\n<\/tr>\n
37<\/td>\n201.12. 1.101.6 Gain control and stability
201.12. 1.101.7 Sweep speed <\/td>\n<\/tr>\n
38<\/td>\n201.12. 1.101.8 *\u00a0Frequency and impulse response <\/td>\n<\/tr>\n
39<\/td>\n201.12. 1.101.9 Gain indicator <\/td>\n<\/tr>\n
40<\/td>\n201.12. 1.101.10 *\u00a0Common mode rejection <\/td>\n<\/tr>\n
41<\/td>\n201.12. 1.101.11 Baseline reset <\/td>\n<\/tr>\n
42<\/td>\n201.12. 1.101.12 *\u00a0Pacemaker pulse display capability <\/td>\n<\/tr>\n
43<\/td>\n201.12. 1.101.13 Rejection of pacemaker pulses <\/td>\n<\/tr>\n
47<\/td>\n201.12. 1.101.14 Synchronizing pulse for cardioversion
201.12. 1.101.15 *\u00a0Heart rate range, accuracy, and QRS detection range <\/td>\n<\/tr>\n
49<\/td>\n201.12. 1.101.16 *\u00a0Channel height and aspect ratio
201.12. 1.101.17 Tall T-wave rejection capability
201.12. 3 Alarm systems <\/td>\n<\/tr>\n
50<\/td>\n201.12.4 Protection against hazardous output
201.12.4.101.1 \u00a0Indications on permanent displays and non-permanent displays
201.13 Hazardous situations and fault conditions
201.14 Programmable electrical medical systems (pems)
201.15 Construction of me\u00a0equipment
201.15. 3.4 Drop test
201.15. 3.4.101 *\u00a0Electrodes and patient\u00a0cables <\/td>\n<\/tr>\n
51<\/td>\n201.15. 4.4 Indicators
201.15. 4.4.101 Indicator of battery operation and battery status
201.16 Me\u00a0systems
201.17 Electromagnetic compatibility of me\u00a0equipment and me\u00a0systems
202 Electromagnetic compatibility \u2013 Requirements and tests
202.5.2.2.2 Requirements applicable to me\u00a0equipment and me\u00a0systems other than those specified for use only in a shielded location
202.6 Electromagnetic compatibility
202.6.1 Emissions
202.6.1.1.2 Tests <\/td>\n<\/tr>\n
52<\/td>\n202.6.2 Immunity
202.6.2.1.10 Compliance criteria <\/td>\n<\/tr>\n
53<\/td>\n202.6.2.2 Electrostatic discharge (esd)
202.6.2.2.1 Requirements
202.6.2.3 Radiated RF electromagnetic fields
202.6.2.3.1 Requirements
202.6.2.3.2 Tests <\/td>\n<\/tr>\n
54<\/td>\n202.6.2.4 Electrical fast transients and bursts
202.6.2.4.1 Requirements <\/td>\n<\/tr>\n
55<\/td>\n202.6.2.4.2 Tests
202.6.2.6 Conducted disturbances, induced by RF fields
\n
202.6.2.6.1 Requirements
202.6.2.6.2 Tests
202.6.2.101 *\u00a0Electrosurgery interference <\/td>\n<\/tr>\n
57<\/td>\n208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
208.6 Alarm systems
208.6.1 Alarm condition
\n
208.6.1.2 Alarm condition priority
\n <\/td>\n<\/tr>\n
58<\/td>\n208.6.3.3 Auditory alarm signals
\n
208.6.3.3.1 *Characteristics of auditory alarm signals
\n <\/td>\n<\/tr>\n
60<\/td>\n208.6.3.3.2 Volume of auditory alarm signals and information signals
\n
208.6.3.3.2.101 *\u00a0Volume of auditory alarm\u00a0signals reducible to zero
208.6.4.2 *Delays to or from a distributed alarm system
\n
208.6.6 Alarm limit
\n

\n208.6.6.2 Adjustable alarm limit
208.6.6.2.101 Adjustment range of heart rate alarm limits
\n
208.6.6.2.102 Resolution of alarm limit settings
\n
208.6.6.2.103 Time to alarm for heart rate alarm conditions
\n <\/td>\n<\/tr>\n
61<\/td>\n208.6.6.2.104 *Technical alarm condition indicating inoperable me equipment
\n
208.6.6.2.105 Assignment of alarm condition priority
\n <\/td>\n<\/tr>\n
62<\/td>\n208.6.8 Alarm signal inactivation states
\n
208.6.8.101 *Technical alarm conditions
\n
208.6.9 *Alarm reset
\n <\/td>\n<\/tr>\n
63<\/td>\n208.6.10 *Non-latching and latching alarm signals
\n
208.6.10.101 *Non-latching alarm signals for technical alarm conditions
\n
208.6.11 Distributed alarm system
\n
208.6.11.2.2 *Failure of remote communication of alarm conditions
\n
208.6.11.101 *Inactivation\/activation of alarm signals at remote components of a distributed alarm system
\n <\/td>\n<\/tr>\n
64<\/td>\nAnnexes <\/td>\n<\/tr>\n
65<\/td>\nAnnex AA Particular guidance and rationale
\n
AA.1 Use with defibrillator
\n
AA.2 Rationale for defibrillator tes
\nt voltages
AA.2.1 General
\n <\/td>\n<\/tr>\n
66<\/td>\nAA.2.2 Summary
\n
AA.2.3 Specific requirement
\n
AA.3 Guidance and rationale for particular clauses
\n
Subclause 201.1.1 — Scope
\n
Subclause 201.5.8 — Sequence of tests
\n
Subclause 201.6.2 — Protection against electric shock
\n <\/td>\n<\/tr>\n
67<\/td>\nSubclause 201.7.9.2.9.101 a) 4) — Additional instructions for use
\n
Subclause 201.7.9.2.9.101 a) 7) — Additional instructions for use
\n
Subclause 201.8.5.2.3 — Patient leads
\n <\/td>\n<\/tr>\n
69<\/td>\nSubclause 201.8.5.5.1 — Defibrillation protection
\n
Subclause 201.11.6.5 — Ingress of water or particulate matter into me equipment and me systems
\n
Subclause 201.11.8 — Interruption of the power supply\/supply mains to the me equipment
\n
Subclause 201.11.8.101 — Protection against depletion of battery
\n <\/td>\n<\/tr>\n
70<\/td>\nSubclause 201.12.1.101 — Essential performance of me equipment
\n <\/td>\n<\/tr>\n
71<\/td>\nSubclause 201.12.1.101.2 — Input dynamic range and differential offset voltage
\n
Subclause 201.12.1.101.3 — Input impedance
\n
Subclause 201.12.1.101.8 — Frequency and impulse response
\n
Subclause 201.12.1.101.10 — Common mode rejection
\n <\/td>\n<\/tr>\n
72<\/td>\nSubclause 201.12.1.101.12 — Pacemaker pulse display capability
\n
Subclause 201.12.1.101.15 — Heart rate range, accuracy, and QRS detection range
\n
Subclause 201.12.1.101.16 — Channel height and aspect ratio
\n <\/td>\n<\/tr>\n
73<\/td>\nSubclause 201.15.3.4.101 — Electrodes and patient cables
\n
Subclause 202.6.2.6.1 bb) — Requirements
\n
Subclause 202.6.2.101 — Electrosurgery interference
Subclause 208.6.1.2 — Alarm condition priority
\n
Subclause 208.6.3.3.1 Characteristics of auditory alarm signals
\n <\/td>\n<\/tr>\n
74<\/td>\nSubclause 208.6.3.3.2.101 — Volume of auditory alarm signals reducible to zero
\n
Subclause 208.6.4.2 — Delays to or from a distributed alarm system
\n
Subclause 208.6.6.2.104 — Technical alarm condition indicating inoperable me equipment
\n
Subclause 208.6.8.101 — Technical alarm conditions
\n <\/td>\n<\/tr>\n
75<\/td>\nSubclause 208.6.9 — Alarm reset
\n
Subclause 208.6.10 — Non-latching and latching alarm signals
\n <\/td>\n<\/tr>\n
76<\/td>\nSubclause 208.6.10.101 — Non-latching alarm signals for technical alarm conditions
\n
Subclause 208.6.11.2.2 — Failure of remote communication of alarm conditions
\n
Subclauses 208.6.11.101 — Inactivation\/activation of alarm signals at remote components of a distributed alarm system
\n <\/td>\n<\/tr>\n
78<\/td>\nAnnex BB Alarm diagrams of Clause 208\/IEC 60601-1-8:2006
\n <\/td>\n<\/tr>\n
81<\/td>\nBibliography
\n <\/td>\n<\/tr>\n
82<\/td>\nIndex of defined terms used in this particular standard
\n <\/td>\n<\/tr>\n
85<\/td>\nErratum – ANSI\/AAMI\/IEC 60601-2-27:2011 – Erratum issued: 31 May 2012 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/IEC 60601-2-27:2011\/(R)2016 – Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2011<\/td>\n86<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198231,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198227","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\/198227","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\/198231"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198227"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198227"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198227"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}