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AAMI ISO 14708-5 : 2010

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES

Available format(s)

Hardcopy , PDF

Superseded date

08-05-2020

Language(s)

English

Published date

01-01-2010

€199.21
Excluding VAT

Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General requirements for non-implantable parts
6 Requirements for particular active implantable medical
   devices
7 General arrangement of the packaging
8 General markings for active implantable medical devices
9 Markings on the sales packaging
10 Construction of the sales packaging
11 Markings on the sterile packaging
12 Construction of the non-reusable packaging
13 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
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
27 Protection of the active implantable medical device from
   electromagnetic non-ionizing radiation
28 Accompanying documentation
Annex AA (informative) - Relationship between the fundamental
                         principles in ISO/TR and the clauses
                         of this part of ISO 14708
Annex BB (informative) - Relationship between the clauses of
                         this part of ISO 14708 and the
                         fundamental principles listed in
                         Annex AA
Annex CC (informative) - Rationale
Annex DD (informative) - In vitro test
Bibliography

Describes requirements for safety and performance of active implantable circulatory support devices.

Committee
WG 6
DevelopmentNote
Supersedes AAMI TIR26. (04/2010)
DocumentType
Standard
Pages
62
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 14708-5:2010 Identical

IEC 60068-1:2013 Environmental testing - Part 1: General and guidance
IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses
ISO 7198:2016 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ISO/TR 14283:2004 Implants for surgery Fundamental principles
ISO/IEC Guide 51:2014 Safety aspects — Guidelines for their inclusion in standards
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
ISO 14708-1:2014 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 5198:1987 Centrifugal, mixed flow and axial pumps Code for hydraulic performance tests Precision grade
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO Guide 31:2015 Reference materials — Contents of certificates, labels and accompanying documentation
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

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