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 14708-1:2014 specifies requirements that are generally applicable to active implantable medical devices.
The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of an active implantable medical device to show compliance.
ISO 14708-1:2014 is applicable not only to active implantable medical devices that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs).
ISO 14708-1:2014 is also applicable to some non-implantable parts and accessories of the active implantable medical devices.
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Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.2
Section sec_3.3
Section sec_3.4
Section sec_3.5
Section sec_3.6
Section sec_3.7
Section sec_3.8
Section sec_3.9
Section sec_3.10
Section sec_3.11
Section sec_3.12
Section sec_3.13
Section sec_3.14
Section sec_3.15
Section sec_3.16
Section sec_3.17
Section sec_3.18
Section sec_3.19
Section sec_3.20
Section sec_3.21
Section sec_3.22
Section sec_3.23
Section sec_3.24
Section sec_3.25
Section sec_3.26
Section sec_3.27
Section sec_3.28
Section sec_3.29
Section sec_3.30
Section sec_3.31
Section sec_3.32
Section sec_3.33
Section sec_3.34
Section sec_3.35
Section sec_3.36
Section sec_3.37
Section sec_3.38
Section sec_3.39
Section sec_3.40
Section sec_4
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.3
Section sec_5.3.1
Section sec_5.3.2
Section sec_5.4
Section sec_5.5
Section sec_5.5.1
Section sec_5.5.2
Section sec_5.5.3
Section sec_5.5.4
Section sec_5.6
Section sec_6
Section sec_7
Section sec_7.1
Section sec_7.2
Section sec_8
Section sec_8.1
Section sec_8.2
Section sec_9
Section sec_9.1
Section sec_9.2
Section sec_9.3
Section sec_9.4
Section sec_9.5
Section sec_9.6
Section sec_9.7
Section sec_9.8
Section sec_9.9
Section sec_9.10
Section sec_9.11
Section sec_9.12
Section sec_9.13
Section sec_9.14
Section sec_10
Section sec_10.1
Section sec_10.2
Section sec_10.3
Section sec_10.4
Section sec_11
Section sec_11.1
Section sec_11.2
Section sec_11.3
Section sec_11.4
Section sec_11.5
Section sec_11.6
Section sec_11.7
Section sec_11.8
Section sec_11.9
Section sec_12
Section sec_12.1
Section sec_12.2
Section sec_12.3
Section sec_13
Section sec_13.1
Section sec_13.2
Section sec_13.3
Section sec_13.4
Section sec_14
Section sec_14.1
Section sec_14.2
Section sec_14.3
Section sec_14.4
Section sec_15
Section sec_15.1
Section sec_15.2
Section sec_16
Section sec_16.1
Section sec_16.2
Section sec_16.3
Section sec_17
Section sec_17.1
Section sec_17.2
Section sec_18
Section sec_18.1
Section sec_18.2
Section sec_18.3
Section sec_19
Section sec_19.1
Section sec_19.2
Section sec_19.3
Section sec_19.4
Section sec_19.5
Section sec_19.6
Section sec_20
Section sec_20.1
Section sec_20.2
Figure fig_1
Figure fig_2
Figure fig_3
Figure fig_4
Table tab_1
Figure fig_5
Section sec_21
Section sec_21.1
Section sec_21.2
Section sec_22
Section sec_22.1
Section sec_22.2
Section sec_23
Section sec_23.1
Section sec_23.2
Section sec_23.3
Section sec_23.4
Section sec_23.5
Section sec_23.6
Section sec_23.7
Section sec_24
Section sec_24.1
Section sec_24.2
Section sec_25
Section sec_25.1
Section sec_25.2
Section sec_26
Section sec_26.1
Section sec_26.2
Section sec_27
Section sec_27.1
Section sec_27.2
Section sec_28
Section sec_28.1
Section sec_28.2
Section sec_28.3
Section sec_28.4
Section sec_28.5
Section sec_28.6
Section sec_28.7
Section sec_28.8
Section sec_28.9
Section sec_28.10
Section sec_28.11
Section sec_28.12
Section sec_28.13
Section sec_28.14
Section sec_28.15
Section sec_28.16
Section sec_28.17
Section sec_28.18
Section sec_28.19
Section sec_28.20
Section sec_28.21
Section sec_28.22
Section sec_28.23
Section sec_28.24
Section sec_28.25
Section sec_28.26
Section sec_28.27
Section sec_28.28
Section sec_28.29
Section sec_28.30
Annex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_5.2___1
Annex sec_5.3___1
Annex sec_5.4___1
Annex sec_5.5___1
Annex sec_5.6___1
Annex sec_7.1___1
Annex sec_8.1___1
Annex sec_8.2___1
Annex sec_9.1___1
Annex sec_9.2___1
Annex sec_9.4___1
Annex sec_9.6___1
Annex sec_9.7___1
Annex sec_9.8___1
Annex sec_9.9___1
Annex sec_9.13___1
Annex sec_9.14___1
Annex sec_10.1___1
Annex sec_10.2___1
Annex sec_10.3___1
Annex sec_10.4___1
Annex sec_11.2___1
Annex sec_11.3___1
Annex sec_11.4___1
Annex sec_11.7___1
Annex sec_11.8___1
Annex sec_13.1___1
Annex sec_13.2___1
Annex sec_13.3___1
Annex sec_13.4___1
Annex sec_14.1___1
Annex sec_14.2___1
Annex sec_14.3___1
Annex sec_14.4___1
Annex sec_16.2___1
Annex sec_16.3___1
Annex sec_17.1___1
Annex sec_19.1___1
Annex sec_19.2___1
Annex sec_19.4___1
Annex sec_20.2___1
Figure fig_A.1
Annex sec_22.1___1
Figure fig_A.2
Annex sec_22.2___1
Annex sec_23.1___1
Annex sec_23.2___1
Annex sec_23.3___1
Annex sec_23.6___1
Annex sec_23.7___1
Annex sec_24.1___1
Annex sec_25.1___1
Annex sec_26.2___1
Annex sec_27.1___1
Annex sec_28.6___1
Annex sec_28.7___1
Annex sec_28.14___1
Annex sec_28.15___1
Annex sec_28.17___1
Annex sec_28.18___1
Annex sec_28.19___1
Annex sec_28.23___1
Annex sec_B
Reference ref_1
Reference ref_2
Reference ref_3
Reference ref_4
Reference ref_5
Reference ref_6
Reference ref_7
Reference ref_8
Reference ref_9
Reference ref_10
Reference ref_11
Reference ref_12
Reference ref_13
Reference ref_14
Reference ref_15
Reference ref_16
Reference ref_17
Reference ref_18
Reference ref_19
Reference ref_20
Reference ref_21
Reference ref_22
Reference ref_23
Reference ref_24
Reference ref_25
Reference ref_26
Reference ref_27
Reference ref_28
Foreword
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
5.4 Data security and protection from harm caused by unauthorized information tampering
5.5 General requirements for risk management
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
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 pack
12 Construction of the non-reusable pack
13 Markings on the active implantable medical device
14 Protection from unintentional biological effects being 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
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
19 Protection from unintended effects caused by the active implantable medical device
20 Protection of the active implantable medical device from damage caused by external defibrillators
21 Protection of the active implantable medical device from changes caused by 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 A (informative) General guidance and rationale
Annex B (informative) Relationship between the fundamental principles in ISO/TR 14283:2004 and the clauses of this part of ISO 14708
Bibliography
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Related Information
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AS/NZS 2817:1997
Implants for surgery - Care and handling of orthopaedic implants
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BS 3531-11:1991
Implants for osteosynthesis, Implants for osteosynthesis. Specification for staples with parallel legs
Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.2
Section sec_3.3
Section sec_3.4
Section sec_3.5
Section sec_3.6
Section sec_3.7
Section sec_3.8
Section sec_3.9
Section sec_3.10
Section sec_3.11
Section sec_3.12
Section sec_3.13
Section sec_3.14
Section sec_3.15
Section sec_3.16
Section sec_3.17
Section sec_3.18
Section sec_3.19
Section sec_3.20
Section sec_3.21
Section sec_3.22
Section sec_3.23
Section sec_3.24
Section sec_3.25
Section sec_3.26
Section sec_3.27
Section sec_3.28
Section sec_3.29
Section sec_3.30
Section sec_3.31
Section sec_3.32
Section sec_3.33
Section sec_3.34
Section sec_3.35
Section sec_3.36
Section sec_3.37
Section sec_3.38
Section sec_3.39
Section sec_3.40
Section sec_4
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.3
Section sec_5.3.1
Section sec_5.3.2
Section sec_5.4
Section sec_5.5
Section sec_5.5.1
Section sec_5.5.2
Section sec_5.5.3
Section sec_5.5.4
Section sec_5.6
Section sec_6
Section sec_7
Section sec_7.1
Section sec_7.2
Section sec_8
Section sec_8.1
Section sec_8.2
Section sec_9
Section sec_9.1
Section sec_9.2
Section sec_9.3
Section sec_9.4
Section sec_9.5
Section sec_9.6
Section sec_9.7
Section sec_9.8
Section sec_9.9
Section sec_9.10
Section sec_9.11
Section sec_9.12
Section sec_9.13
Section sec_9.14
Section sec_10
Section sec_10.1
Section sec_10.2
Section sec_10.3
Section sec_10.4
Section sec_11
Section sec_11.1
Section sec_11.2
Section sec_11.3
Section sec_11.4
Section sec_11.5
Section sec_11.6
Section sec_11.7
Section sec_11.8
Section sec_11.9
Section sec_12
Section sec_12.1
Section sec_12.2
Section sec_12.3
Section sec_13
Section sec_13.1
Section sec_13.2
Section sec_13.3
Section sec_13.4
Section sec_14
Section sec_14.1
Section sec_14.2
Section sec_14.3
Section sec_14.4
Section sec_15
Section sec_15.1
Section sec_15.2
Section sec_16
Section sec_16.1
Section sec_16.2
Section sec_16.3
Section sec_17
Section sec_17.1
Section sec_17.2
Section sec_18
Section sec_18.1
Section sec_18.2
Section sec_18.3
Section sec_19
Section sec_19.1
Section sec_19.2
Section sec_19.3
Section sec_19.4
Section sec_19.5
Section sec_19.6
Section sec_20
Section sec_20.1
Section sec_20.2
Figure fig_1
Figure fig_2
Figure fig_3
Figure fig_4
Table tab_1
Figure fig_5
Section sec_21
Section sec_21.1
Section sec_21.2
Section sec_22
Section sec_22.1
Section sec_22.2
Section sec_23
Section sec_23.1
Section sec_23.2
Section sec_23.3
Section sec_23.4
Section sec_23.5
Section sec_23.6
Section sec_23.7
Section sec_24
Section sec_24.1
Section sec_24.2
Section sec_25
Section sec_25.1
Section sec_25.2
Section sec_26
Section sec_26.1
Section sec_26.2
Section sec_27
Section sec_27.1
Section sec_27.2
Section sec_28
Section sec_28.1
Section sec_28.2
Section sec_28.3
Section sec_28.4
Section sec_28.5
Section sec_28.6
Section sec_28.7
Section sec_28.8
Section sec_28.9
Section sec_28.10
Section sec_28.11
Section sec_28.12
Section sec_28.13
Section sec_28.14
Section sec_28.15
Section sec_28.16
Section sec_28.17
Section sec_28.18
Section sec_28.19
Section sec_28.20
Section sec_28.21
Section sec_28.22
Section sec_28.23
Section sec_28.24
Section sec_28.25
Section sec_28.26
Section sec_28.27
Section sec_28.28
Section sec_28.29
Section sec_28.30
Annex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_5.2___1
Annex sec_5.3___1
Annex sec_5.4___1
Annex sec_5.5___1
Annex sec_5.6___1
Annex sec_7.1___1
Annex sec_8.1___1
Annex sec_8.2___1
Annex sec_9.1___1
Annex sec_9.2___1
Annex sec_9.4___1
Annex sec_9.6___1
Annex sec_9.7___1
Annex sec_9.8___1
Annex sec_9.9___1
Annex sec_9.13___1
Annex sec_9.14___1
Annex sec_10.1___1
Annex sec_10.2___1
Annex sec_10.3___1
Annex sec_10.4___1
Annex sec_11.2___1
Annex sec_11.3___1
Annex sec_11.4___1
Annex sec_11.7___1
Annex sec_11.8___1
Annex sec_13.1___1
Annex sec_13.2___1
Annex sec_13.3___1
Annex sec_13.4___1
Annex sec_14.1___1
Annex sec_14.2___1
Annex sec_14.3___1
Annex sec_14.4___1
Annex sec_16.2___1
Annex sec_16.3___1
Annex sec_17.1___1
Annex sec_19.1___1
Annex sec_19.2___1
Annex sec_19.4___1
Annex sec_20.2___1
Figure fig_A.1
Annex sec_22.1___1
Figure fig_A.2
Annex sec_22.2___1
Annex sec_23.1___1
Annex sec_23.2___1
Annex sec_23.3___1
Annex sec_23.6___1
Annex sec_23.7___1
Annex sec_24.1___1
Annex sec_25.1___1
Annex sec_26.2___1
Annex sec_27.1___1
Annex sec_28.6___1
Annex sec_28.7___1
Annex sec_28.14___1
Annex sec_28.15___1
Annex sec_28.17___1
Annex sec_28.18___1
Annex sec_28.19___1
Annex sec_28.23___1
Annex sec_B
Reference ref_1
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Reference ref_7
Reference ref_8
Reference ref_9
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Reference ref_12
Reference ref_13
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Reference ref_15
Reference ref_16
Reference ref_17
Reference ref_18
Reference ref_19
Reference ref_20
Reference ref_21
Reference ref_22
Reference ref_23
Reference ref_24
Reference ref_25
Reference ref_26
Reference ref_27
Reference ref_28
Foreword
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
5.4 Data security and protection from harm caused by unauthorized information tampering
5.5 General requirements for risk management
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
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 pack
12 Construction of the non-reusable pack
13 Markings on the active implantable medical device
14 Protection from unintentional biological effects being 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
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
19 Protection from unintended effects caused by the active implantable medical device
20 Protection of the active implantable medical device from damage caused by external defibrillators
21 Protection of the active implantable medical device from changes caused by 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 A (informative) General guidance and rationale
Annex B (informative) Relationship between the fundamental principles in ISO/TR 14283:2004 and the clauses of this part of ISO 14708
Bibliography