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Active implantable medical devices directive

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  Directive

Active implantable medical devices Directive (90/385/EEC)

  Scope

This Directive shall apply to active implantable medical devices

Definitions:

‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the:

— diagnosis, prevention, monitoring, treatment or alleviation of disease or injury,

— investigation, replacement or modification of the anatomy or of a physiological process,

— control of conception, and which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, but which may be assisted in its function by such means;

‘active medical device’ means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity

‘active implantable medical device’ means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure;

  Description

The Active Implantable Medical Device (AIMD) Directive 90/385/EEC defines an active implantable medical device as "any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure". As one of the highest risk categories of device, they are subject to rigorous regulatory controls both pre- and post-market. The regulatory controls set out in the AIMD Directive also apply to any accessories that are used to enable the device to operate as intended, for examples leads, programmers, controllers, battery packs, software applications, implant kits and refill kits.

  Harmonised standards

EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556-1:2001/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
EN 1041:2008 Information supplied by the manufacturer of medical devices
EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
EN ISO 10993-1:2009/AC:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
EN ISO 10993-4:2009 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)
EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
EN ISO 10993-6:2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
Show all the standards...
EN 556-1:2001
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Par...
EN 556-1:2001/AC:2006
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Par...
EN 556-2:2015
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Pa...
EN 1041:2008
Information supplied by the manufacturer of medical devices
EN ISO 10993-1:2009
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management p...
EN ISO 10993-1:2009/AC:2010
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management p...
EN ISO 10993-3:2014
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and repro...
EN ISO 10993-4:2009
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (I...
EN ISO 10993-5:2009
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009...
EN ISO 10993-6:2009
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 1...
Show all the standards...

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