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  • ISO 14708-4:2008

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    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    Withdrawn date:  09-03-2022

    Language(s):  English

    Published date:  05-11-2008

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes ISO/DIS 14708-4. (11/2008)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    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
    ASTM F 3020 : 2016 Performance Standard for Hand-Worn Metal Detectors Used in Safety and Security
    PREN 50527-1 : DRAFT 2015 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL
    BS EN 50527-1:2016 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices General
    ASTM F 2401 : 2016 : REDLINE Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices
    TR 102 756 : 1.1.1 ELECTROMAGNETIC COMPATIBILITY AND RADIO SPECTRUM MATTERS (ERM); SYSTEM REFERENCE DOCUMENT FOR REVISED SPECTRUM REQUIREMENTS FOR RFID EQUIPMENT AND INDUCTIVE LOOP SYSTEMS OPERATING IN THE FREQUENCY RANGE OF 9 KHZ TO 148,5 KHZ
    ASTM F 3278 : 2017 Standard Performance Specification for Hand-Held Metal Detectors Used in Safety and Security

    Standards Referencing This Book - (Show below) - (Hide below)

    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
    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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