{"id":198177,"date":"2024-10-19T12:36:57","date_gmt":"2024-10-19T12:36:57","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-14708-5-2010-ra-2015\/"},"modified":"2024-10-25T05:10:08","modified_gmt":"2024-10-25T05:10:08","slug":"aami-14708-5-2010-ra-2015","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-14708-5-2010-ra-2015\/","title":{"rendered":"AAMI 14708 5 2010 RA 2015"},"content":{"rendered":"

Specifies requirements for safety and performance of active implantable circulatory support devices. Excluded from this scope are intra-aortic balloon pumps, external corporeal perfusion devices and cardiomyplasty. This standard specifies type tests, animal studies and clinical evaluation requirements that are to be carried out to show compliance with this standard<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 14708-5:2010\/(R)2015, Implants for surgery\u2014Active implantable medical devices\u2014Part 5: Circulatory support devices <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and recommended practices <\/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>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
9<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nBackground of ANSI\/AAMI adoption of ISO 14708-5:2010 <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
12<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
14<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
18<\/td>\n4 Symbols and abbreviated terms
5 General requirements for non-implantable parts <\/td>\n<\/tr>\n
19<\/td>\n6 Requirements for particular active implantable medical devices
6.101 Intended clinical use\/indications
6.102 System description
6.102.1 General
6.102.2 Principle of operation
6.102.3 Design consideration
6.102.4 System configuration
6.102.5 System performance and operating limits
6.103 Design analysis <\/td>\n<\/tr>\n
20<\/td>\n6.104 Risk analysis
6.105 Human factors
6.106 In vitro design evaluation and system performance testing
6.106.1 Objective
6.106.2 Initial design evaluation of the pump system
6.106.2.1 Pump performance test
6.106.2.2 Fluid dynamic analysis <\/td>\n<\/tr>\n
21<\/td>\n6.106.2.3 Vibration measurement
6.106.2.4 Cavitation observation
6.106.3 System characterization
6.106.3.1 General
6.106.3.2 Test set-up
6.106.3.3 Test articles
6.106.3.3.1 General <\/td>\n<\/tr>\n
22<\/td>\n6.106.3.3.2 Substitution of device components
6.106.3.4 Test equipment
6.106.3.4.1 General
6.106.3.4.2 Mock circulatory loop
6.106.3.4.3 Physiological limits
6.106.3.4.4 Blood analogue fluid
6.106.3.4.5 Test measurement equipment
6.106.3.4.5.1 Transducers
6.106.3.4.5.2 Use of the device system as test measurement equipment <\/td>\n<\/tr>\n
23<\/td>\n6.106.3.4.5.3 Data handling
6.106.3.5 Test conditions
6.106.3.6 Parameters to be measured
6.106.3.7 Data analysis
6.106.3.8 \u201cWorst case\u201d operating conditions <\/td>\n<\/tr>\n
24<\/td>\n6.106.4 System component testing
6.106.4.1 Control and drive units
6.106.4.1.1 External units
6.106.4.1.2 Implantable controllers and drivers
6.106.4.2 Programming and monitoring units
6.106.4.3 Power supplies <\/td>\n<\/tr>\n
25<\/td>\n6.106.4.4 Batteries
6.106.4.5 Connections and connectors
6.106.4.5.1 Electrical connection
6.106.4.5.2 Lines
6.106.4.5.3 Vascular grafts, cannulae, blood conduits, atrial and apical cuffs <\/td>\n<\/tr>\n
26<\/td>\n6.106.4.6 Artificial\/prosthetic valves
6.106.4.7 Transcutaneous energy transmission systems
6.107 Electromagnetic compatibility <\/td>\n<\/tr>\n
27<\/td>\n6.108 Materials qualification
6.109 Biocompatibility
6.110 Environmental testing <\/td>\n<\/tr>\n
28<\/td>\n6.111 In vivo evaluation
6.111.1 Objective
6.111.1.1 General
6.111.1.2 Safety
6.111.1.3 Performance
6.111.2 Definition of success or failure
6.111.3 Test articles
6.111.4 Test system
6.111.4.1 Test animals
6.111.4.1.1 General <\/td>\n<\/tr>\n
29<\/td>\n6.111.4.1.2 Choice of animal model
6.111.4.1.3 Sample size and implant duration
6.111.4.2 Control
6.111.5 Test equipment
6.111.6 Preoperative animal care
6.111.7 Implant procedure
6.111.8 Special instructions for early termination <\/td>\n<\/tr>\n
30<\/td>\n6.111.9 Post-operative care
6.111.10 Anticoagulation
6.111.11 Adverse events
6.111.12 System performance
6.111.13 Measurement of physiological parameters
6.111.14 Blood measurements
6.111.14.1 Timing
6.111.14.2 Blood parameters
6.111.15 Necropsy and device retrieval <\/td>\n<\/tr>\n
31<\/td>\n6.111.16 Macroscopic examination
6.111.17 Histological examination
6.111.18 Explanted device analysis
6.111.19 Data analysis
6.112 Reliability <\/td>\n<\/tr>\n
33<\/td>\n6.113 Clinical evaluation
7 General arrangement of the packaging
8 General markings for active implantable medical devices
8.101 General
9 Markings on the sales packaging <\/td>\n<\/tr>\n
34<\/td>\n10 Construction of the sales packaging
11 Markings on the sterile packaging
12 Construction of the non-reusable packaging <\/td>\n<\/tr>\n
35<\/td>\n13 Markings on the active implantable medical device
14 Protection from unintentional biological effects caused by the active implantable medical device
15 Protection from harm to the patient or user caused by external physical features of the active implantable medical device
16 Protection from harm to the patient caused by electricity
17 Protection from harm to the patient caused by heat
18 Protection from ionizing radiation released or emitted from the active implantable medical device
19 Protection from unintended effects caused by the device
19.1 Line power supplies <\/td>\n<\/tr>\n
36<\/td>\n19.2 Risk analysis <\/td>\n<\/tr>\n
37<\/td>\n19.3 Software verification and validation
20 Protection of the device from damage caused by external defibrillators
21 Protection of the device from changes caused by high-power electrical fields applied directly to the patient
22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments
23 Protection of the active implantable medical device from mechanical forces
24 Protection of the active implantable medical device from damage caused by electrostatic discharge
25 Protection of the active implantable medical device from damage caused by atmospheric pressure changes
26 Protection of the active implantable medical device from damage caused by temperature changes <\/td>\n<\/tr>\n
38<\/td>\n27 Protection of the active implantable medical device from electromagnetic non-ionizing radiation
28 Accompanying documentation
28.1 Instructions for use <\/td>\n<\/tr>\n
40<\/td>\nAnnex AA Relationship between the fundamental principles in ISO\/TR 14283 and the clauses of this part of ISO 14708 <\/td>\n<\/tr>\n
50<\/td>\nAnnex BB Relationship between the clauses of this part of ISO 14708 and the fundamental principles listed in Annex AA <\/td>\n<\/tr>\n
52<\/td>\nAnnex CC Rationale
CC.1 General <\/td>\n<\/tr>\n
53<\/td>\nCC.2 Notes on specific clauses and subclauses
6.106.4.6 Artificial\/prosthetic valves
6.111.2 An example of a definition of success <\/td>\n<\/tr>\n
54<\/td>\n6.111.6 Preoperative animal care
6.111.9 Post-operative care <\/td>\n<\/tr>\n
55<\/td>\n6.111.11 Reference for adverse event definitions
6.111.13 Measurement of physiological parameters
6.111.14.2 Blood parameters <\/td>\n<\/tr>\n
56<\/td>\n6.112 r) One example of foreseeable physiological conditions for a left ventricular assist device <\/td>\n<\/tr>\n
57<\/td>\nAnnex DD In vitro test
DD.1 Flow visualization
DD.1.1 Test methods
DD.1.2 Examples of test variables
DD.2 Example of the test conditions used to characterize the system <\/td>\n<\/tr>\n
58<\/td>\nDD.3 Examples of measurement for volume displacement and rotary devices
DD.3.1 Volume displacement devices <\/td>\n<\/tr>\n
59<\/td>\nDD.3.2 Rotary devices
DD.4 Application of computational fluid dynamic (CFD) analysis
DD.4.1 General
DD.4.2 Design and performance to be evaluated with CFD analysis <\/td>\n<\/tr>\n
60<\/td>\nDD.4.3 Procedures governing analysed quantities <\/td>\n<\/tr>\n
61<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ ISO 14708-5: 2010\/(R)2015 – Implants for surgery-Active implantable medical devices-Part 5: Circulatory support devices<\/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>\n62<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198179,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198177","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\/198177","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\/198179"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198177"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198177"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198177"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}