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BIS IS/ISO 14708-3 : 2008

Current
Current

The latest, up-to-date edition.

IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS
Published date

09-05-2013

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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