{"id":198368,"date":"2024-10-19T12:37:41","date_gmt":"2024-10-19T12:37:41","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-60601-2-25-2011-ra-2016\/"},"modified":"2024-10-25T05:10:44","modified_gmt":"2024-10-25T05:10:44","slug":"aami-60601-2-25-2011-ra-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-60601-2-25-2011-ra-2016\/","title":{"rendered":"AAMI 60601 2 25 2011 RA 2016"},"content":{"rendered":"

This standard specifies requirements for infant phototherapy equipment and can also be applied to infant phototherapy equipment used for compensation or alleviation of disease, injury or disability.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nTitle Page
\n <\/td>\n<\/tr>\n
3<\/td>\nAAMI Standard
\n
Copyright information
\n <\/td>\n<\/tr>\n
4<\/td>\nTable of contents
\n <\/td>\n<\/tr>\n
7<\/td>\nGlossary of equivalent standards
\n <\/td>\n<\/tr>\n
9<\/td>\nCommittee representation
\n <\/td>\n<\/tr>\n
10<\/td>\nBackground of ANSI\/AAMI adoption of IEC 60601-2-25:2011
\n <\/td>\n<\/tr>\n
11<\/td>\nForeword
\n <\/td>\n<\/tr>\n
13<\/td>\nIntroduction
\n <\/td>\n<\/tr>\n
14<\/td>\n201.1 Scope, object and related standards
\n
201.1.1 *\u00a0Scope <\/td>\n<\/tr>\n
15<\/td>\n201.1.2 Object
201.1.3 Collateral standards
201.1.4 Particular standards <\/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
201.5 General requirements for testing of me\u00a0equipment <\/td>\n<\/tr>\n
19<\/td>\n201.5.3 * Ambient temperature, humidity, atmospheric pressure
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
201.6.6 Mode of operation <\/td>\n<\/tr>\n
20<\/td>\n201.7 ME
\n equipment identification, marking and documents
201.7.4 Making of controls and instruments
201.7.4.101 * Patient cable and patient cable to me\u00a0equipment connector <\/td>\n<\/tr>\n
22<\/td>\n201.7.9.2 Instructions for use
201.7.9.2.101 Additional instructions for use
\n <\/td>\n<\/tr>\n
23<\/td>\n201.8 Protection against electrical hazards from me\u00a0equipment
201.8.3 Classification of applied parts <\/td>\n<\/tr>\n
24<\/td>\n201.8.5 Separation of parts
\n
201.8.5.2.3 Patient leads
\n
201.8.5.5.1 Defibrillation protection
\n <\/td>\n<\/tr>\n
28<\/td>\n201.8.5.5.2 Energy reduction test <\/td>\n<\/tr>\n
29<\/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
30<\/td>\n201.11 Protection against excessive temperatures and other hazards
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.12.1 Accuracy of controls and instruments
\n
201.12.1.101 Essential performance and accuracy of ME
\n equipment
201.12.1.101.1 Automated measurements on ECGs
\n
201.12.1.101.2 * Requirements for amplitude measurements
201.12.1.101.3 Requirements for interval measurements
201.12.1.101.3.1 * Requirements for absolute interval and wave duration measurements <\/td>\n<\/tr>\n
31<\/td>\n201.12.1.101.3.2 * Requirements for interval measurements on biological ecgs <\/td>\n<\/tr>\n
32<\/td>\n201.12.4.101 * Indication of inoperable electrocardiograph
201.12.4.102 Leads
201.12.4.102.1 lead representation, nomenclature and definition <\/td>\n<\/tr>\n
33<\/td>\n201.12.4.102.2 Minimum required configuration
201.12.4.102.3 Test of lead networks
201.12.4.102.3.1 General
201.12.4.102.3.2 Goldberger and Wilson leads <\/td>\n<\/tr>\n
34<\/td>\n201.12.4.102.4 Recovery time
201.12.4.103 * Input impedance
201.12.4.104 Required gains <\/td>\n<\/tr>\n
35<\/td>\n201.12.4.105 Reduction of the effects of unwanted external voltages
201.12.4.105.1 * Common mode rejection <\/td>\n<\/tr>\n
36<\/td>\n201.12.4.105.2 * Overload tolerance <\/td>\n<\/tr>\n
37<\/td>\n201.12.4.105.3 * Filters (including line frequency interference filters)
201.12.4.106 Baseline
201.12.4.106.1 * Noise level <\/td>\n<\/tr>\n
38<\/td>\n201.12.4.106.2 Channel crosstalk <\/td>\n<\/tr>\n
39<\/td>\n201.12.4.107 Distortion
201.12.4.107.1 * Frequency response
201.12.4.107.1.1 Tests with sinusoidal and impulse signals
201.12.4.107.1.1.1 High frequency response <\/td>\n<\/tr>\n
40<\/td>\n201.12.4.107.1.1.2 Low frequency (impulse) response <\/td>\n<\/tr>\n
41<\/td>\n201.12.4.107.1.2 Test with calibration ecgs
201.12.4.107.2 Linearity and dynamic range <\/td>\n<\/tr>\n
42<\/td>\n 201.12.4.107.3 Sampling and amplitude quantization during data acquisition <\/td>\n<\/tr>\n
43<\/td>\n201.12.4.108 Printing, electronic storage and transmission
201.12.4.108.1 Record identification
201.12.4.108.2 Patient identification
201.12.4.108.3 Ecg reporting on paper
201.12.4.108.3.1 Time and event markers
201.12.4.108.3.2 Recording speed <\/td>\n<\/tr>\n
44<\/td>\n201.12.4.108.3.3 Time and amplitude ruling
201.12.4.109 Use with cardiac pacemakers <\/td>\n<\/tr>\n
45<\/td>\n201.13 Hazardous situations and fault conditions
201.14 Programmable electrical medical systems (PEMS
\n)
201.15 Construction of ME
\n equipment
201.16 ME
\n systems <\/td>\n<\/tr>\n
46<\/td>\n201.17 Electromagnetic compatibility of ME equipment and ME
\n systems
202 Electromagnetic compatibility \u2013 Requirements and tests
202.5.2.2.2 Requirements applicable to ME equipment and ME systems other than those specified for use only in a shielded location
202.6.1 Emissions
\n
202.6.1.1.2 Tests <\/td>\n<\/tr>\n
47<\/td>\n202.6.2 Immunity
202.6.2.1.10 *Compliance criteria <\/td>\n<\/tr>\n
48<\/td>\n202.6.2.2 Electrostatic discharge (ESD
\n)
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
49<\/td>\n202.6.2.4 Electrical fast transients and bursts
202.6.2.4.1 Requirements
202.6.2.4.2 Tests
\n
202.6.2.6 Conducted disturbances, induced by RF fields
202.6.2.6.1 Requirements
202.6.2.6.2 Tests <\/td>\n<\/tr>\n
50<\/td>\n202.6.2.101 * Electrosurgery interference <\/td>\n<\/tr>\n
52<\/td>\nAnnexes
\n <\/td>\n<\/tr>\n
53<\/td>\nAnnex AA, Particular guidance and rationale
\n
AA.1 General considerations
\n
AA.2 Guidance and rationale for particular subclauses
\n
Subclause 201.1.1 — Scope
\n
Subclause 201.5.3 — Ambient temperature, humidity, atmospheric pressure
\n
Subclause 201.5.8 — Sequence of tests
\n <\/td>\n<\/tr>\n
54<\/td>\nSubclause 201.7.4.101 — Patient cable and patient cable to ME equipment connector
\n
Subclause 201.7.9.2.101 a) 14) — Additional instructions for use
\n
Subclause 201.8.5.5.1 — Defibrillation protection
\n <\/td>\n<\/tr>\n
56<\/td>\nSubclause 201.12.1.101.1 — Automated measurements on ECGs
\n
Subclause 201.12.1.101.2 — Requirements for amplitude measurements
\n
Subclause 201.12.1.101.3.1 — Requirements for absolute interval and wave duration measurements
\n <\/td>\n<\/tr>\n
57<\/td>\nSubclause 201.12.1.101.3.2 — Requirements for interval measurements on biological ECGs
\n
Subclause 201.12.4.101 — Indication of inoperable electrocardiographs
\n
Subclause 201.12.4.103 — Input impedance
\n
Subclause 201.12.4.105.1 — Common mode rejection
\n
Subclause 201.12.4.105.2 — Overload tolerance
\n
Subclause 201.12.4.105.3 — Filters (including line frequency interference filters)
\n <\/td>\n<\/tr>\n
58<\/td>\nSubclause 201.12.4.106.1 — Noise level
\n
Subclause 201.12.4.107.1 — Frequency response
\n <\/td>\n<\/tr>\n
59<\/td>\nSubclause 202.6.2.1.10 — Compliance criteria
\n
Subclause 202.6.2.101 — Electrosurgery interference
\n
AA.3 Guidelines to input ECG data to electrocardiographs
\n <\/td>\n<\/tr>\n
61<\/td>\nAnnex BB, Electrodes, their positions, identifications and color codes
\n <\/td>\n<\/tr>\n
63<\/td>\nAnnex CC, Leads, their identification and color codes (other than those specified in 201.12.4.102)
\n
CC.1 Unipolar chest leads according to Wilson
\n
CC.2 Bipolar chest leads
\n
CC.3 Unipolar limb leads
\n
CC.4 Chest leads Nehb
\n <\/td>\n<\/tr>\n
64<\/td>\nAnnex DD, Polarity of patient leads (other than those specified in 201.12.4.102)
\n <\/td>\n<\/tr>\n
65<\/td>\nAnnex EE, Additional marking of electrodes
\n
EE.1 Combined use electrodes
\n
EE.2 Combined standard and Frank electrodes
\n <\/td>\n<\/tr>\n
66<\/td>\nAnnex FF, Definitions and rules for the measurement of electrocardiograms
\n
FF.1 The electrocardiogram
\n
FF.2 Determination of global intervals
\n <\/td>\n<\/tr>\n
67<\/td>\nFF.3 Waveform durations, isoelectric segments
\n <\/td>\n<\/tr>\n
68<\/td>\nFF.4 Baseline (amplitude measurement references)
\n <\/td>\n<\/tr>\n
69<\/td>\nFF.5 Definition of waveforms, measurement of minimum waves
\n
FF.6 Acceptance of minimum waves
\n <\/td>\n<\/tr>\n
72<\/td>\nAnnex GG, Calibration and test data sets
\n
GG.1 Calibration and analytical ECGs
\n <\/td>\n<\/tr>\n
73<\/td>\nGG.2 Biological ECGs
\n <\/td>\n<\/tr>\n
74<\/td>\nAnnex HH, CTS test atlas
\n
HH.1 Introduction
\n
HH.2 The test database
\n
HH.2.1 Rationale
\n <\/td>\n<\/tr>\n
75<\/td>\nHH.2.2 Set-up of the test database
\n <\/td>\n<\/tr>\n
76<\/td>\nHH.2.3 Calibration ECGs
\n <\/td>\n<\/tr>\n
79<\/td>\nHH.2.4 Analytical ECGs
\n <\/td>\n<\/tr>\n
80<\/td>\nHH.3 Signal characteristics
\n <\/td>\n<\/tr>\n
81<\/td>\nHH.4 List of ECGs
\n
HH.4.1 Calibration ECGs
\n
HH.4.2 Analytical ECGs
\n <\/td>\n<\/tr>\n
101<\/td>\nHH.5 Wave duration tables adapted for different amplitude quantization
\n
HH.5.1 CALECG Wave On-\/Offsets, Sample R
\nate = 1000 S\/s <\/td>\n<\/tr>\n
102<\/td>\nHH.5.2 CALECG Interval Durations, Sample Rate = 1,000 S\/s
\n <\/td>\n<\/tr>\n
103<\/td>\nHH.5.3 CALECG Wave On-\/Offsets, Sample Rate = 500 S\/s
\n <\/td>\n<\/tr>\n
104<\/td>\nHH.5.4 CALECG Interval Durations, Sample Rate = 500 S\/s
\n <\/td>\n<\/tr>\n
105<\/td>\nBibliography
\n <\/td>\n<\/tr>\n
106<\/td>\nIndex of defined terms used in this particular standard
\n <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/IEC 60601-2-25:2011\/(R)2016 – Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs<\/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>\n107<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198373,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198368","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\/198368","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\/198373"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198368"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198368"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198368"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}