Table of Contents

Foreword <br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Symbols and abbreviated terms <br>5 General requirements for non-implantable parts<br>6 Requirements for particular active implantable medical <br>&nbsp;&nbsp;&nbsp;devices <br>7 General arrangement of the packaging<br>8 General markings for active implantable medical devices<br>9 Markings on the sales packaging <br>10 Construction of the sales packaging <br>11 Markings on the sterile pack <br>12 Construction of the non-reusable pack <br>13 Markings on the active implantable medical device<br>14 Protection from unintentional biological effects caused by <br>&nbsp;&nbsp;&nbsp;the active implantable medical device<br>15 Protection from harm to the patient or user caused by <br>&nbsp;&nbsp;&nbsp;external physical features of the active implantable <br>&nbsp;&nbsp;&nbsp;medical device<br>16 Protection from harm to the patient caused by electricity<br>17 Protection from harm to the patient caused by heat<br>18 Protection from ionizing radiation released or emitted <br>&nbsp;&nbsp;&nbsp;from the active implantable medical device<br>19 Protection from unintended effects caused by the device<br>20 Protection of the device from damage caused by external <br>&nbsp;&nbsp;&nbsp;defibrillators<br>21 Protection of the device from changes caused by <br>&nbsp;&nbsp;&nbsp;high-power electrical fields applied directly to the <br>&nbsp;&nbsp;&nbsp;patient <br>22 Protection of the active implantable medical device from <br>&nbsp;&nbsp;&nbsp;changes caused by miscellaneous medical treatments<br>23 Protection of the active implantable medical device from <br>&nbsp;&nbsp;&nbsp;mechanical forces<br>24 Protection of the active implantable medical device from <br>&nbsp;&nbsp;&nbsp;damage caused by electrostatic discharge<br>25 Protection of the active implantable medical device from <br>&nbsp;&nbsp;&nbsp;damage caused by atmospheric pressure changes<br>26 Protection of the active implantable medical device from <br>&nbsp;&nbsp;&nbsp;damage caused by temperature changes <br>27 Protection of the active implantable medical device from <br>&nbsp;&nbsp;&nbsp;electromagnetic non-ionizing radiation<br>28 Accompanying documentation<br>Annex AA (informative) - Relationship between the fundamental <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;principles in ISO/TR 14283 and the <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;clauses of this part of ISO 14708<br>Annex BB (informative) - Relationship between the clauses of <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;this part of ISO 14708 and the <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;fundamental principles listed in <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Annex AA<br>Annex CC (informative) - Rationale<br>Annex DD (informative) - In vitro test<br>Bibliography

Abstract

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

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 150
Supersedes	ISO/DIS 14708-5 : 60.00 (2010)