MEDICAL DEVICES: In Vitro Diagnostic (EU DIR 98/79/EC) Collection

Description:
MEDICAL DEVICES: In Vitro Diagnostic (EU DIR 98/79/EC) Collection contains more than 30 documents.

This Directive was recently introduced in the EU as the third in a series of Medical Device Directives. The purpose of the Directive is to ensure that only safe and effective products are sold in the European market, with clearly outlined regulations regarding manufacturing, import and marketing. On December 7, 2003, compliance to the IVD Directive became mandatory. This Directive defines an in vitro diagnostic medical device as any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information (a) concerning a physiological or pathological state, or (b) concerning a congenital abnormality, or (c) to determine the safety and compatibility with potential recipients, or (d) to monitor therapeutic measures. Examples include HIV test kits; blood gas analyzers; multi-analyte control sera; immunoassay analyzers ; blood collection tubes and specimen containers; microtitre plate readers, claimed for diagnostic use; and media for growing cultures, used for diagnostic purposes.

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BSI BS EN 12286

1999 In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biological Origin - Presentation of Reference Measurement Procedures-AMD 11034: January 2001;

BSI BS EN 12287

In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biological Origin - Description of Reference Materials

BSI BS EN 12322

In Vitro Diagnostic Medical Devices - Culture Media for Microbiology - Performance Criteria for Culture Media-AMD 13482: December 24, 2001

BSI BS EN 1280- 1

Agent Specific Filling Systems for Anaesthetic Vaporizers - Part 1: Rectangular Keyed Filling Systems-AMD 11039: January 2001

BSI BS EN 13532

General Requirements for in Vitro Diagnostic Medical Devices for Self- Testing

BSI BS EN 13612

Performance evaluation of in vitro diagnostic medical devices-CORR 14302: February 27, 2003;

BSI BS EN 13640

Stability Testing of in Vitro Diagnostic Reagents

BSI BS EN 13641

Elimination or Reduction of Risk of Infection Related to In Vitro Diagnostic Reagents

BSI BS EN 13975

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

BSI BS EN 14136

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

BSI BS EN 14254

In vitro diagnostic medical devices Single-use receptacles for the collection of specimens, other than blood, from humans

BSI BS EN 14820

Single-use containers for human venous blood specimen collection- Supersedes BS ISO 6710:1995

BSI BS EN 375

Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Professional Use

BSI BS EN 376

Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Self-Testing

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 591

Instructions for Use for In Vitro Diagnostic Instruments for Professional Use

BSI BS EN 592

Instructions for Use for in Vitro Diagnostic Instruments for Self- Testing

BSI BS EN 61010-2- 101

Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

BSI BS EN 794- 1

Lung Ventilators - Part 1: Particular Requirements for Critical Care Ventilators-AMD 13084: July 2001; Supersedes BS 5724-2.12: 1990; Also Known as BS 5724- 2.202: 1997

BSI BS EN 928

Guidance on the Application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for In Vitro Diagnostic Medical Devices (G)

BSI BS EN 980

Graphical Symbols for Use in the Labelling of Medical Devices

BSI BS EN ISO 10993- 8

Biological Evaluation of Medical Devices - Part 8: Selection and Qualification of Reference Materials for Biological Tests

BSI BS EN ISO 13485

Medical devices Quality management systems Requirements for regulatory purposes

BSI BS EN ISO 14937

Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices-CORR 13353:September 2001; CORR 15195:June 16, 2004

BSI BS EN ISO 14971

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

BSI BS EN ISO 15197

In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus-CORR 14616: August 5, 2003;

BSI BS EN ISO 17511

In vitro diagnostics medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials

BSI BS EN ISO 18153

In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials

BSI BS EN ISO 4135

Anaesthetic and Respiratory Equipment - Vocabulary

EU 98/79/EC

Directive of the European Parliament and of the Council on in Vitro Diagnostic Medical Devices

EU 98/79/EC

CORRIGENDUM to the European Parliament and of the Council on in Vitro Diagnostic Medical Devices