{"id":198233,"date":"2024-10-19T12:37:10","date_gmt":"2024-10-19T12:37:10","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-60601-2-47-2012-ra-2016\/"},"modified":"2024-10-25T05:10:18","modified_gmt":"2024-10-25T05:10:18","slug":"aami-60601-2-47-2012-ra-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-60601-2-47-2012-ra-2016\/","title":{"rendered":"AAMI 60601 2 47 2012 RA 2016"},"content":{"rendered":"

Specifies the basic safety and essential performance of ambulatory electrocardiographic (ECG) systems. Within the scope of this standard are systems of the following types: a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyze it later on a separate unit or record and analyze the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard; and b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.<\/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
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>\nContents
\n <\/td>\n<\/tr>\n
6<\/td>\nGlossary of equivalent standards
\n <\/td>\n<\/tr>\n
8<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nBackground of ANSI\/AAMI adoption of IEC 60601-2-47:2012 <\/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\u2003Scope <\/td>\n<\/tr>\n
15<\/td>\n201.1.2\u2003Object
201.1.3\u2003Collateral Standards
201.1.4\u2003Particular standards <\/td>\n<\/tr>\n
16<\/td>\n201.2 Normative references
201.3 Terms and definitions <\/td>\n<\/tr>\n
19<\/td>\n201.4 General requirements
201.4.3\u2003Essential performance
201.4.101\u2003Additional essential performance requirements
201.5 General requirements for testing of me equipment
201.5.3\u2003Ambient temperature, humidity, atmospheric pressure
201.6 Classification of me equipment and me systems <\/td>\n<\/tr>\n
20<\/td>\n201.6.2\u2003Protection against electrical shock
201.6.6\u2003Mode of operation
201.7 ME
\n equipment identification, marking and documents
201.7.2\u2003Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.101 Lead wire identification
\n <\/td>\n<\/tr>\n
21<\/td>\n201.7.9.2 Instructions for use
\n
201.7.9.2.101 Additional instructions for use
\n <\/td>\n<\/tr>\n
22<\/td>\n201.8 Protection against electrical hazards from me equipment
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
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.12.1\u2003Accuracy of controls and instruments
201.12.1.101\u2003*Algorithm testing
201.12.1.101.1\u2003General
201.12.1.101.1.1\u2003*Databases
201.12.1.101.1.1.1\u2003General description of available databases <\/td>\n<\/tr>\n
23<\/td>\n201.12.1.101.1.1.2\u2003*Records to be excluded during testing <\/td>\n<\/tr>\n
24<\/td>\n201.12.1.101.1.2 *Testing requirements
\n
201.12.1.101.1.3 *Test environment
\n <\/td>\n<\/tr>\n
25<\/td>\n201.12.1.101.1.4 Multiple-lead analysis
\n
201.12.1.101.1.5 *Requirements for the evaluation report
\n
201.12.1.101.1.5.1 *Required statistics
\n
201.12.1.101.1.5.2 *Requirements for all arrhythmia algorithms
\n <\/td>\n<\/tr>\n
26<\/td>\n201.12.1.101.1.5.3 *Requirements for algorithms with optional capabilities
\n <\/td>\n<\/tr>\n
28<\/td>\n202.12.1.101.1.6 Simulated test patterns
\n
201.12.1.101.2\u2003*Automated analysis
201.12.1.101.2.1\u2003Use of standard databases <\/td>\n<\/tr>\n
29<\/td>\n201.12.1.101.2.2\u2003*Use of annotation files <\/td>\n<\/tr>\n
30<\/td>\n201.12.1.101.2.3\u2003Beat-by-beat comparison
201.12.1.101.2.3.1\u2003General description <\/td>\n<\/tr>\n
31<\/td>\n201.12.1.101.2.3.2\u2003Method for beat-by-beat comparison <\/td>\n<\/tr>\n
32<\/td>\n201.12.1.101.2.3.3\u2003Heart rate, and heart rate or RR interval variability
201.12.1.101.2.3.3.1\u2003*Heart rate measurement
201.12.1.101.2.3.3.2 *Heart rate variability or RR interval variability measurement test patterns <\/td>\n<\/tr>\n
34<\/td>\n201.12.1.101.2.4 Run-by-run comparison
\n
201.12.1.101.2.4.1\u2003General description <\/td>\n<\/tr>\n
35<\/td>\n201.12.1.101.2.4.2\u2003Terms and symbols <\/td>\n<\/tr>\n
36<\/td>\n201.12.1.101.2.4.3\u2003Run sensitivity summary matrix
201.12.1.101.2.4.4\u2003Run positive predictivity summary matrix
201.12.1.101.2.5\u2003VF and AF
\n comparisons <\/td>\n<\/tr>\n
37<\/td>\n201.12.1.101.3\u2003*Physician report \u2013 minimum requirements
201.12.1.101.3.1\u2003Heart rate
201.12.1.101.3.2\u2003Supraventricular ectopy
201.12.1.101.3.3\u2003Ventricular ectopy <\/td>\n<\/tr>\n
38<\/td>\n201.12.1.101.3.4\u2003Bradycardia data
201.12.1.101.3.5\u2003Pauses
201.12.1.101.3.6\u2003*ST
\n segment shifts
201.12.1.101.3.7\u2003ECG
\n hard copy <\/td>\n<\/tr>\n
39<\/td>\n201.12.4\u2003Protection against hazardous output
201.12.4.4\u2003Incorrect output
201.12.4.4.101\u2003*Linearity and dynamic range <\/td>\n<\/tr>\n
41<\/td>\n201.12.4.4.102\u2003*Input impedance
201.12.4.4.103\u2003*Common mode rejection <\/td>\n<\/tr>\n
44<\/td>\n201.12.4.4.104\u2003*Gain accuracy
201.12.4.4.105\u2003*Gain stability
201.12.4.4.106\u2003*System noise
201.12.4.4.107\u2003*Multichannel crosstalk <\/td>\n<\/tr>\n
45<\/td>\n201.12.4.4.108 *Frequency response <\/td>\n<\/tr>\n
46<\/td>\n201.12.4.4.109\u2003*Function in the presence of pacemaker pulses <\/td>\n<\/tr>\n
47<\/td>\n201.12.4.4.110\u2003*Timing accuracy
201.12.4.4.111\u2003*Gain settings and switching
201.12.4.4.112\u2003*Temporal alignment <\/td>\n<\/tr>\n
48<\/td>\n201.13 Hazardous situations and fault conditions
201.14 Programmable electrical medical systems (PEMS
\n)
201.15 Construction of ME
\nequipment
201.15.3\u2003Mechanical strength
201.15.3.4.1\u2003Hand held ME
\n equipment
201.15.3.4.2\u2003Portable me equipment <\/td>\n<\/tr>\n
49<\/td>\n201.15.4\u2003ME
\n equipment components and general assembly
201.15.4.3\u2003Batteries
201.15.4.3.101\u2003Monitoring time and retention of data
201.15.4.3.101.1\u2003*Monitoring time
201.15.4.3.101.2\u2003*Data retention <\/td>\n<\/tr>\n
50<\/td>\n201.16 ME
\n systems
201.16.5\u2003Separation devices
201.17 *Electromagnetic compatibility of ME equipment and ME
\n systems
202 Electromagnetic compatibility \u2013 Requirements and tests
202.6.1.1\u2003Protection of radio services
202.6.1.1.1\u2003Requirements
202.6.1.1.2\u2003Tests <\/td>\n<\/tr>\n
52<\/td>\n202.6.2\u2003Immunity
202.6.2.3\u2003*Radiated RF electromagnetic fields
202.6.2.3.2\u2003Tests
Annexes
\n <\/td>\n<\/tr>\n
53<\/td>\nAnnex AA (informative) Particular guidance and rationale
AA.1 General
AA.2 Rationale for particular clauses and subclauses
Subclause 201.7.9.2.101 — Additional instructions for use
\n
Subclause 201.12.1.101.1 — Algorithm testing
\n <\/td>\n<\/tr>\n
54<\/td>\nSubclause 201.12.1.101.1.1 — Databases
\n
Subclause 201.12.1.101.1.1.2 — Records to be excluded during testing
\n <\/td>\n<\/tr>\n
55<\/td>\nSubclause 201.12.1.101.1.2 — Testing requirements
\n
Subclause 201.12.1.101.1.3 — Test environment
\n <\/td>\n<\/tr>\n
56<\/td>\nSubclause 201.12.1.101.1.5 — Requirements for the evaluation report
\n
Subclause 201.12.1.101.1.5.1 — Required statistics
\n <\/td>\n<\/tr>\n
57<\/td>\nSubclause 201.12.1.101.1.5.2 — Requirements for all arrhythmia algorithms
\n <\/td>\n<\/tr>\n
61<\/td>\nSubclause 201.12.1.101.1.5.3 — Requirements for algorithms with optional capabilities
\n <\/td>\n<\/tr>\n
64<\/td>\nSubclause 201.12.1.101.2 — Automated analysis
\n
Subclause 201.12.1.101.2.2 — Use of annotation files
\n
Subclause 201.12.1.101.2.3.3.1 — Heart rate measurements
\n <\/td>\n<\/tr>\n
65<\/td>\nSubclause 201.12.1.101.2.3.3.2 — Heart rate variability or RR interval variability measurement test patterns
\n <\/td>\n<\/tr>\n
70<\/td>\nSubclause 201.12.1.101.3 — Physician report — minimum requirements
\n
Subclause 201.12.1.101.3.6 — ST segment shifts
\n <\/td>\n<\/tr>\n
71<\/td>\nSubclause 201.12.4.4.101 — Linearity and dynamic range
\n
Subclause 201.12.4.4.102 — Input impedance
\n
Subclause 201.12.4.4.103 — Common mode rejection
\n <\/td>\n<\/tr>\n
72<\/td>\nSubclause 201.12.4.4.104 — Gain accuracy
\n
Subclause 201.12.4.4.105 — Gain stability
Subclause 201.12.4.4.106 — System noise
\n
Subclause 201.12.4.4.107 — Multichannel crosstalk
\n <\/td>\n<\/tr>\n
73<\/td>\nSubclause 201.12.4.4.108 — Frequency response
\n
Subclause 201.12.4.4.109 — Function in the presence of pacemaker pulses
\n <\/td>\n<\/tr>\n
74<\/td>\nSubclause 201.12.4.4.110 — Timing accuracy
\n
Subclause 201.12.4.4.111 — Gain settings and switching
\n
Subclause 201.12.4.4.112 — Temporal alignment
\n
Subclause 201.15.4.3.101.1 — Monitoring time
\n <\/td>\n<\/tr>\n
75<\/td>\nSubclause 201.15.4.3.101.2 — Data retention
\n
Clause 201.17 — Electromagnetic compatibility of ME equipment and ME systems
\n
Subclause 202.6.2.3 — Radiated RF electromagnetic fields
\n <\/td>\n<\/tr>\n
76<\/td>\nBibliography
\n <\/td>\n<\/tr>\n
77<\/td>\nIndex of defined terms used in this particular standard
\n <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/IEC 60601-2-47:2012\/(R)2016 – Medical electrical equipment – Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic 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>\n2012<\/td>\n77<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198236,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198233","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\/198233","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\/198236"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198233"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198233"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198233"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}