{"id":198323,"date":"2024-10-19T12:37:30","date_gmt":"2024-10-19T12:37:30","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-60601-2-4-2010-rl\/"},"modified":"2024-10-25T05:10:36","modified_gmt":"2024-10-25T05:10:36","slug":"aami-60601-2-4-2010-rl","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-60601-2-4-2010-rl\/","title":{"rendered":"AAMI 60601 2 4 2010 RL"},"content":{"rendered":"

This consolidated version includes the amendment which updates references and clarifies the scope as well as provides additional information for AEDs, defibrillator electrodes, audible warnings and cables. (Red-line)<\/p>\n

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1<\/td>\nANSI\/AAMI\/IEC 60601-2-4:2010\/A1:2018; Medical electrical equipment\u2014Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1 (Redline Version) <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nBackground of ANSI\/AAMI adoption of IEC 60601-2-4:2010\/A1:2018 <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\n201.1 Scope, object and related standards
201.1. 1 * Scope <\/td>\n<\/tr>\n
14<\/td>\n201.1. 2 Object
201.1. 3 Collateral standards
201.1. 4 Particular standards <\/td>\n<\/tr>\n
15<\/td>\n201.2 Normative references
201.3 Terms and definitions <\/td>\n<\/tr>\n
18<\/td>\n201.4 General requirements
201.4. 2 Risk management process for me equipment or me systems
201.4. 2.101 * Additional risk management requirements
201.4. 3 Essential performance
201.4. 3.101 * Additional essential performance requirements
Table 201.101 \u2013 Distributed ESSENTIAL PERFORMANCE requirements
201.5 General requirements for testing of me equipment
201.5.3 * Ambient temperature, humidity, atmospheric pressure <\/td>\n<\/tr>\n
19<\/td>\n201.5.4 Other conditions
201.5.8 Sequence of tests
201.6 Classification of me equipment and me systems
201.6.2 * Protection against electric shock
201.7 Me equipment identification, marking and documents
201.7.2 Marking on the outside of me equipment or me equipment parts
201.7.2.7 * Electrical input power from the supply mains
201.7.2.101 * Concise operating instructions <\/td>\n<\/tr>\n
20<\/td>\n201.7.2.102 * Internally powered me equipment
201.7.2.103 Disposable defibrillator electrodes
201.7.4 Marking of controls and instruments
201.7.4.101 * Selected energy control
201.7.9.2.4 * Electrical power source <\/td>\n<\/tr>\n
21<\/td>\n201.7.9.2.101 * Supplementary instructions for use <\/td>\n<\/tr>\n
22<\/td>\n201.7.9.3 Technical description
201.7.9.3.101 * Essential performance data for defibrillation
201.7.9.3.102 * Essential performance data of any synchronizer <\/td>\n<\/tr>\n
23<\/td>\n201.7.9.3.103 * Essential performance data of the rhythm recognition detector
201.8 Protection against electrical hazards from me equipment
201.8.3 * Classification of applied parts
201.8.5.5.1 * Defibrillation protection <\/td>\n<\/tr>\n
24<\/td>\n201.8.5.5.101 * Isolation of defibrillator electrodes <\/td>\n<\/tr>\n
25<\/td>\nFigure 201.101 \u2013 Dynamic test for limitation of energyfrom different parts of the ME EQUIPMENT
201.8.5.5.102 * Applied parts not being defibrillator electrodes
201.8.5.5.103 Charging of the energy storage device
201.8.7 * Leakage currents and patient auxiliary currents
201.8.7.1 * General requirements <\/td>\n<\/tr>\n
26<\/td>\n201.8.7.3 * Allowable values
201.8.7.4.7 Measurement of the patient leakage current
201.8.8.3 * Dielectric strength <\/td>\n<\/tr>\n
29<\/td>\nFigure 201.102 \u2013 Allowed current versus applied test voltage
201.8.9.1 Values
201.8.9.1.5 * me equipment rated for high altitudes
201.8.9.1.101 * defibrillator electrodes, high-voltage circuits and cables <\/td>\n<\/tr>\n
30<\/td>\n201.9 Protection against mecahnical 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
201.11.1.3\u2003Measurements <\/td>\n<\/tr>\n
31<\/td>\n201.11.6.3 * Spillage on me equipment and me systems
201.11.6.5 Ingress of water or particulate matter into me equipment and me systems <\/td>\n<\/tr>\n
32<\/td>\n201.11.6.7 * Sterilization of me equipment and me systems
201.12 * Accuracy of controls and instruments and protection against hazardous outputs
201.12.1 * Accuracy of controls and instruments
201.12.2 Usability
201.12.2.101 * ELECTRODE energizing controls <\/td>\n<\/tr>\n
33<\/td>\n201.12.2.102 Display of signals
201.12.3 Alarm systems
201.12.3.101 * Audible warnings prior to energy delivery
201.12.4 Protection against hazardous output
201.12.4.1 * Intentional exceeding of safety limits
201.12.4.101 * Output voltage
201.12.4.102 * Unintentional energy <\/td>\n<\/tr>\n
34<\/td>\n201.12.4.103 * Internal discharge circuit
201.13 Hazardous situations and fault conditions
201.13.1.3 * Exceeding leakage current or voltage limits
201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
201.15.4 * Me equipment components and general assembly
201.15.4.3 Batteries
201.15.4.3.101 * Non-rechargeable Battery replacement <\/td>\n<\/tr>\n
35<\/td>\n201.15.4.3.102 Battery charging indicator
201.15.4.3.103 * Rechargeable battery <\/td>\n<\/tr>\n
36<\/td>\n201.15.4.101 * Defibrillator electrodes and their cables <\/td>\n<\/tr>\n
38<\/td>\nFigure 201.103 \u2013 Examples of cord anchorages that require testing <\/td>\n<\/tr>\n
39<\/td>\nFigure 201.104 \u2013 Test apparatus for flexible cords and their anchorages
201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
201.101 * Charging time
201.101.1 Requirements for frequent use, manual defibrillators <\/td>\n<\/tr>\n
40<\/td>\n201.101.2 Requirements for infrequent use, manual defibrillators <\/td>\n<\/tr>\n
41<\/td>\n201.101.3 * Requirements for frequent use, automated external defibrillators
201.101.4 * Requirements for infrequent use, automated external defibrillators <\/td>\n<\/tr>\n
42<\/td>\n201.102 Internal electrical power source
201.102.1 General
201.102.2 * Requirements for manual defibrillators
201.102.3 * Requirements for automated external defibrillators (AED)
201.102.3.1 Frequent use AED <\/td>\n<\/tr>\n
43<\/td>\n201.102.3.2 Infrequent use AED <\/td>\n<\/tr>\n
44<\/td>\n201.103 * Endurance
201.104 * Synchronizer <\/td>\n<\/tr>\n
45<\/td>\n201.105 * Recovery of the monitor and\/or ECG input after defibrillation
201.105.1 ECG signal derived via defibrillator electrodes <\/td>\n<\/tr>\n
46<\/td>\nFigure 201.105 \u2013 Arrangement for test of recovery after defibrillation
201.105.2 ECG signal derived via any separate monitoring electrodes <\/td>\n<\/tr>\n
47<\/td>\nFigure 201.106 \u2013 Arrangement of monitoring electrodes on sponge
Figure 201.107 \u2013 Arrangement for recovery test after defibrillation
201.105.3 ECG signal derived via non-reusable defibrillator electrodes <\/td>\n<\/tr>\n
48<\/td>\n201.106 * Disturbance to the monitor from charging or internal discharging <\/td>\n<\/tr>\n
49<\/td>\nFigure 201.108 \u2013 Arrangement for test of disturbance from chargingand internal discharging
201.107 * Requirements for rhythm recognition detector
Table 201.102 \u2013 RHYTHM RECOGNITION DETECTOR categories <\/td>\n<\/tr>\n
50<\/td>\n201.108 Defibrillator electrodes
201.108.1 * Defibrillator electrodes for monitoring and defibrillation, and (optionally) pacing
201.108.1.1 * AC small signal impedance
201.108.1.2 * AC large signal impedance <\/td>\n<\/tr>\n
51<\/td>\n201.108.1.3 * Combined offset instability and internal noise
201.108.1.4 * Defibrillation recovery
201.108.1.5 * Biological response
201.108.1.6 * DC offset voltage
201.108.1.7 * Electrode active area
201.108.1.8 * Electrode adhesion and contact to patient <\/td>\n<\/tr>\n
52<\/td>\n201.108.1.9 * Packaging and shelf life
201.108.1.10 * Universal-function electrodes
201.108.1.11 * Cable length
201.109 * External pacing (U.S.)
201.109.1 Pacing mode activation
201.109.2 Pacing delivery <\/td>\n<\/tr>\n
53<\/td>\n201.109.2.1 Separate pacing pathway
201.109.2.2 Combined pathway
201.109.3.1 Pace pulse duration accuracy
201.109.3.2 Pace pulse duration stability <\/td>\n<\/tr>\n
54<\/td>\n201.109.4 Pacing pulse current
201.109.4.1 Pacing pulse current accuracy
201.109.4.2 Pacing pulse current stability
201.109.5 Pacing rate
201.109.5.1 Pacing rate accuracy <\/td>\n<\/tr>\n
55<\/td>\n201.109.5.2 Pacing rate stability
201.109.6 Pacing protocol
201.109.7 Demand pacing <\/td>\n<\/tr>\n
56<\/td>\n201.109.8 Pacer lead-off indication <\/td>\n<\/tr>\n
57<\/td>\nFigure 201.110 \u2013 Test circuit for DEFIBRILLATOR overload test of pacing output circuitry
202 * Electromagnetic compatibility \u2013 Requirements and tests
202.6.1 Emissions
202.6.1.1 Protection of radio services
202.6.1.1.1 Requirements
202.6.2.2 Electrostatic discharge (ESD)
202.6.2.2.1 Requirements <\/td>\n<\/tr>\n
58<\/td>\n202.6.2.2.2 Tests
202.6.2.3 Radiated RF electromagnetic fields
202.6.2.3.1 Requirements
202.6.2.3.2 * Tests
202.6.2.4 Electrical fast transients and bursts
202.6.2.4.1 Requirements
202.6.2.4.2 Tests <\/td>\n<\/tr>\n
59<\/td>\n202.6.2.5 Surges
202.6.2.5.1 Requirements
202.6.2.6 Conducted disturbances, induced by RF fields
202.6.2.6.1 Requirements
202.6.2.6.2 Tests
202.6.2.8.1 Power frequency magnetic fields
202.6.2.8.1.1 Requirements
202.6.2.8.1.2 Test
Annexes <\/td>\n<\/tr>\n
60<\/td>\nAnnex C (informative) Guide to marking and labelling requirements for me equipment and me systems
201.C.1 Marking on the outside of me equipment, me systems or their parts
Table 201.C.101 \u2013 Marking on the outside of a CARDIAC DEFIBRILLATOR or its parts
201.C.3 Marking of controls and instruments
Table 201.C.102 \u2013 Marking of controls and instruments of a CARDIAC DEFIBRILLATOR
201.C.4 Accompanying documents, general <\/td>\n<\/tr>\n
61<\/td>\nTable 201.C.103 \u2013 ACCOMPANYING DOCUMENTS, general
201.C.5 Accompanying documents, Instructions for use
Table 201.C.104 \u2013 ACCOMPANYING DOCUMENTS, instructions for use
201.C.6 Accompanying documents, technical description
Table 201.C.105 \u2013 ACCOMPANYING DOCUMENTS, technical description <\/td>\n<\/tr>\n
62<\/td>\nAnnex AA (informative) Particular guidance and rationale
AA.1 General guidance
AA.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n
63<\/td>\nSubclause 201.4.2.101 \u2013 Additional risk management requirements
Subclause 201.4.3.101 \u2013 Additional essential performance requirements <\/td>\n<\/tr>\n
75<\/td>\nFigure AA.1 \u2013 Simulated PATIENT load <\/td>\n<\/tr>\n
77<\/td>\nAnnex BB (informative) Mapping between the elements of the second edition of IEC 60601-2-4 and IEC 60601-2-4:2010
Table BB.1 \u2013 Mapping between the elements of the second edition of IEC 60601-2-4 and IEC 60601-2-4:2010 <\/td>\n<\/tr>\n
82<\/td>\nBibliography <\/td>\n<\/tr>\n
83<\/td>\nIndex of defined terms used in this particular standard <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/IEC 60601-2-4:2010\/A1:2018 (Redline Version) – Medical electrical equipment-Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2010<\/td>\n84<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198324,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198323","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\/198323","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\/198324"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198323"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198323"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198323"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}