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ISO 14708-4:2008

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Implants for surgery Active implantable medical devices Part 4: Implantable infusion pumps
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

03-09-2022

Language(s)

English

Published date

11-05-2008

ISO 14708-4:2008 is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body.

ISO 14708-4:2008 is also applicable to some non-implantable parts and accessories of the devices.

The tests that are specified in ISO 14708-4:2008 are type tests intended to be carried out on a sample of a device to show compliance, and are not intended to be used for the routine testing of manufactured products.

DevelopmentNote
Supersedes ISO/DIS 14708-4. (11/2008)
DocumentType
Standard
Pages
42
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy

Standards Relationship
NEN ISO 14708-4 : 2009 Identical
AAMI ISO 14708-4 : 2008 Identical
AAMI ISO 14708-4:2008(R2011) Identical

I.S. EN 50527-1:2016 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL
15/30321267 DC : DRAFT FEB 2015 BS EN 50527-1 - PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL
EN 50527-1:2016 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
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ASTM F 3278 : 2017 Standard Performance Specification for Hand-Held Metal Detectors Used in Safety and Security

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
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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
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
CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
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 11631:1998 Measurement of fluid flow Methods of specifying flowmeter performance
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements

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