BIS IS/ISO 14708-3 : 2008
Current
The latest, up-to-date edition.
IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS
05-09-2013
NATIONAL FOREWORD
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 pack
12 Construction of the non-reusable pack
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 14283 [8] 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
Bibliography
Pertains to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.
| Committee |
MHD 7
|
| DevelopmentNote |
Issued: May 2013. (08/2013)
|
| DocumentType |
Standard
|
| PublisherName |
Bureau of Indian Standards
|
| Status |
Current
|
| Standards | Relationship |
| ISO 14708-3:2017 | Identical |
| CISPR 14-1:2016 | Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 1: Emission |
| IEC TR 61000-2-7:1998 | Electromagnetic compatibility (EMC) - Part 2: Environment - Section 7: Low frequency magnetic fields in various environments |
| AAMI PC69 : 2007 | |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| BIS IS 13450-1-2 : 2012(R2017) | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - SECTION 2: COLLATERAL STANDARD: ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS |
| IEC TR 61000-2-3:1992 | Electromagnetic compatibility (EMC) - Part 2: Environment - Section 3: Description of the environment - Radiated and non-network-frequency-related conducted phenomena |
| CFR 47(PTS0-19) : OCT 2017 | TELECOMMUNICATION - FEDERAL COMMUNICATIONS COMMISSION |
| CISPR 22:2008 | Information technology equipment - Radio disturbance characteristics - Limits and methods of measurement |
| 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 780:2015 | Packaging Distribution packaging Graphical symbols for handling and storage of packages |
| 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 |
| MIL-STD-461 Revision G:2015 | REQUIREMENTS FOR THE CONTROL OF ELECTROMAGNETIC INTERFERENCE CHARACTERISTICS OF SUBSYSTEMS AND EQUIPMENT |
| IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
| IEEE C95.1-2005 | IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| BIS IS 13450-1 : 2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| CISPR 11:2015 RLV | Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
| BIS IS/ISO 14708-1 : 2000 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| IEC 62226-2-1:2004 | Exposure to electric or magnetic fields in the low and intermediate frequency range - Methods for calculating the current density and internal electric field induced in the human body - Part 2-1: Exposure to magnetic fields - 2D models |
| IEEE C95.6-2002 | IEEE Standard for Safety Levels With Respect to Human Exposure to Electromagnetic Fields, 0-3 kHz |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 15223:2000 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
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