Purchase the full subscription package now and enjoy a 40% discount, along with free updates for future editions.
AS ISO 14708.1:2015
$269.08
Implants for surgery — Active implantable medical devices, Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Adopts ISO 14708-1: 2014 to specify general requirements on safety, marking and information to be provided by manufacturers of active implantable medical devices.
Table of contents
Header
About this publication
Preface
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviations (optional)
5 General requirements for active implantable medical devices
5.1 General requirements for non-implantable parts
5.2 General requirements for software
5.3 Usability of non-implantable parts
5.3.1 Usability of non-implantable parts of an active implantable medical device connected to or equipped with an electrical power source
5.3.2 Usability of non-implantable parts of an active implantable medical device not connected to or equipped with an electrical power source
5.4 Data security and protection from harm caused by unauthorized information tampering
5.5 General requirements for risk management
5.5.1 Risk management policy
5.5.2 Risk management file
5.5.3 Risk management plan
5.5.4 Risk management process
5.6 Misconnection of parts of the active implantable medical device
6 Requirements for particular active implantable medical devices
7 General arrangement of the packaging
7.1
7.2
8 General markings for active implantable medical devices
8.1
8.2
9 Markings on the sales packaging
9.1
9.2
9.3
9.4
9.5
9.6
9.7
9.8
9.9
9.10
9.11
9.12
9.13
9.14
10 Construction of the sales packaging
10.1
10.2
10.3
10.4
11 Markings on the sterile pack
11.1
11.2
11.3
11.4
11.5
11.6
11.7
11.8
11.9
12 Construction of the non-reusable pack
12.1
12.2
12.3
13 Markings on the active implantable medical device
13.1
13.2
13.3
13.4
14 Protection from unintentional biological effects being caused by the active implantable medical device
14.1
14.2
14.3
14.4
15 Protection from harm to the patient or user caused by external physical features of the active implantable medical device
15.1
15.2
16 Protection from harm to the patient caused by electricity
16.1
16.2
16.3
17 Protection from harm to the patient caused by heat
17.1 Protection from harm to the patient caused by heat
17.2 Active implantable medical device intended to supply heat
18 Protection from ionizing radiation released or emitted from the active implantable medical device
18.1
18.2
18.3
19 Protection from unintended effects caused by the active implantable medical device
19.1
19.2
19.3
19.4
19.5
19.6
20 Protection of the active implantable medical device from damage caused by external defibrillators
20.1
20.2
21 Protection of the active implantable medical device from changes caused by electrical fields applied directly to the patient
21.1
21.2
22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments
22.1
22.2
23 Protection of the active implantable medical device from mechanical forces
23.1
23.2
23.3
23.4
23.5
23.6
23.7
24 Protection of the active implantable medical device from damage caused by electrostatic discharge
24.1
24.2
25 Protection of the active implantable medical device from damage caused by atmospheric pressure changes
25.1
25.2
26 Protection of the active implantable medical device from damage caused by temperature changes
26.1
26.2
27 Protection of the active implantable medical device from electromagnetic non-ionizing radiation
