MEDICAL DEVICES: Active Implantable(EU DIR 90/385/EEC) Collection

Description:
MEDICAL DEVICES: Active Implantable(EU DIR 90/385/EEC) Collection contains more than 40 documents.

The Active Implantable Medical Devices Directive applies to devices and their accessories. The Directive covers implantable products such as cardiac pacemakers, defibrillators, infusion pumps, diaphragm stimulators, bladder stimulators, and neurostimulators. In addition, the Directive covers accessories and software such as image-enhancing software intended for diagnostic purposes. "Active" implies that the function of these devices is dependent upon a source of electrical energy or any source of power other than that directly generated by the human body or gravity. An “Implantable Medical Device” refers to 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. Active Implantable Devices must be designed and manufactured such that when implanted under the conditions and for the purposes laid down, they will not compromise the clinical condition or safety of patients. They must not pose any risk to the person implanting them or where applicable, to any other persons.

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BSI BS EN 1041

Information Supplied by the Manufacturer with Medical Devices

BSI BS EN 1174- 1

Sterilization of Medical Devices - Estimation of the Population of Micro- Organisms on Product Part 1: Requirements

BSI BS EN 1174- 2

Sterilization of Medical Devices - Estimation of the Population of Micro- Organisms on Product Part 2: Guidance

BSI BS EN 1174- 3

Sterilization of Medical Devices - Estimation of the Population of Micro- Organisms on Product Part 3: Guide to the Methods for Validation of Microbiological Techniques

BSI BS EN 13824

Sterilization of medical devices Aseptic processing of liquid medical devices Requirements

BSI BS EN 1441

Medical Devices - Risk Analysis-Superseded by BS EN ISO 14971

BSI BS EN 30993- 6

Biological Evaluation of Medical Devices Part 6: Tests for Local Effects After Implantation (ISO 10993-6: 1994) (N)

BSI BS EN 45502- 1

Active Implantable Medical Devices Part 1: General Requirements for Safety, Marking and Information to be Provided by the Manufacturer

BSI BS EN 45502-2- 1

Active implantable medical devices Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)- Supersedes BS 6902-1: 1990 and BS 6902-1: Supplement No 1: 1996;

BSI BS EN 46003

Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9003

BSI BS EN 475

Medical Devices - Electrically-Generated Alarm Signals-Supersedes BS 7618: Part 1: 1992; Superseded by BS EN 60601-1-8:2004

BSI BS EN 550

Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization

BSI BS EN 552

Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation-AMD 10623: September 1999; AMD 13085: June 2001

BSI BS EN 554

Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Moist Heat

BSI BS EN 556- 1

Sterilization of Medical Devices - Requirements for Medical Devices to Be Designated "Sterile" - Part 1: Requirements for Terminally Sterilized Medical Devices

BSI BS EN 556- 2

Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices

BSI BS EN 60601- 1

Medical Electrical Equipment Part 1: General Requirements for Safety- AMD 6715: December 1990; AMD 7940: November 1995; AMD 9693: October 1997; Renumbers BS 5724: Part 1: 1989

BSI BS EN 866- 1

Biological Systems for Testing Sterilizers and Sterilization Processes Part 1: General Requirements

BSI BS EN 866- 2

Biological Systems for Testing Sterilizers and Sterilization Processes Part 2: Particular Systems for Use in Ethylene Oxide Sterilizers

BSI BS EN 866- 3

Biological Systems for Testing Sterilizers and Sterilization Processes Part 3: Particular Systems for Use in Moist Heat Sterilizers

BSI BS EN 868- 1

Packaging Materials and Systems for Medical Devices Which are to be Sterilized Part 1: General Requirements and Test Methods

BSI BS EN 980

Graphical Symbols for Use in the Labelling of Medical Devices

BSI BS EN ISO 10993- 1

Biological evaluation of medical devices Part 1: Evaluation and testing

BSI BS EN ISO 10993- 10

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity-CORR 14275: December 20, 2002;

BSI BS EN ISO 10993- 11

Biological Evaluation of Medical Devices Part 11: Tests for Systematic Toxicity (N)

BSI BS EN ISO 10993- 12

Biological evaluation of medical devices Part 12: Sample preparation and reference materials

BSI BS EN ISO 10993- 13

Biological Evaluation of Medical Devices - Part 13: Identification and Quantification of Degradation Products from Polymeric Medical Devices

BSI BS EN ISO 10993- 16

Biological Evaluation of Medical Devices Part 16: Toxicokinetic Study Design for Degradation Products and Leachables

BSI BS EN ISO 10993- 17

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances

BSI BS EN ISO 10993- 4

Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood-CORR 14295: January 29, 2003; Supersedes BS EN 30993-4: 1994;

BSI BS EN ISO 10993- 5

Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity-Supersedes BS EN 30993-5:1994;

BSI BS EN ISO 10993- 7

Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals (N)

BSI BS EN ISO 10993- 9

Biological Evaluation of Medical Devices - Part 9: Framework for Identification and Quantification of Potential Degradation Products-AMD 10742: January 2000;

BSI BS EN ISO 13485

Medical devices Quality management systems Requirements for regulatory purposes

BSI BS EN ISO 13488

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002-Supersedes BS EN 46002: 1997; ISO 13488: 1996

BSI BS EN ISO 14155- 1

Clinical investigation of medical devices for human subjects Part 1: General requirements-CORR 14481: May 15, 2003; Supersedes BS EN 540: 1993;

BSI BS EN ISO 14155- 2

Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans

BSI BS EN ISO 14971

Medical Devices - Application of Risk Management to Medical Devices-CORR 14652; August 19, 2003

CEN PREN 45502-2- 2

Active Implantable Medical Devices Part 2-2: Particular Requirements for Active Implantable Medical Devices Intended to Treat Tachyarrhythmia (Includes Implantable Defibrillators)

EU 90/385/EEC

Commission Communication in the Framework of the Implementation of Council Directive in Relation to Active Implantable Medical Devices (1), and Council Directive 93/42/EEC of 14 June 1993 in Relation to Medical Devices (2)-98/C 144/03; Text with EEA Relev

EU 90/385/EEC

Council Directive on the Approximation of the Laws of the Member States Relating to Active Implantable Medical Devices (NEW APP)-for Related Standards See TEST/90/385 : 1996

EU 93/42/EEC

Council Directive Concerning Medical Devices-for Related Standards See TEST/93/42 : 1996

EU 93/42/EEC

Commission Communication in the Framework of the Implementation of Council Directive in Relation to Medical Devices (1)-98/C 144/02; Text with EEA Relevance

EU 93/68/EEC

Council Directive Amending Directives 87/404/EEC (Simple Pressure Vessels), 88/ 378/EEC (Safety of Toys), 89/106/EEC (Construction Products), 89/336/EEC (Electromagnetic Compatibility), 89/392/ EEC (Machinery), 89/686/ EEC (Personal Protective Equipment),