Medical Device Standards Library - CEN Collection

Description: Medical Devices - In Vitro Diagnostic
CEN Collection contains more than 15 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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CEN EN 1497

Rescue Equipment - Rescue Harnesses

CEN EN 29002

Quality Systems: Model for Quality Assurance in Production and Installation

CEN EN 45001

General Criteria for the Operation of Testing Laboratories (PNS 1501: 1991)

CEN EN 45002

General Criteria for the Assessment of Testing Laboratories (PNS 1502:1991)

CEN EN ISO 14155- 1

Clinical investigation of medical devices for human subjects Part 1: General requirements-ISO 14155-1: 2003; Supersedes EN 540: 1993

CEN PREN 13159

Compatibility of Medical Equipment with Oxygen

CEN PREN 1631- 1

Cleanroom Technology - Basic Aspects - Part 1: Terminology

CEN PREN 1631- 2

Cleanroom Technology - Basic Aspects - Part 2: Design, Construction and Operation of Cleanrooms and Clean Air Devices

CEN PREN 1632- 1

Cleanroom Technology - Biocontamination Control - Part 1: Basic Principles and Determination of Critical Control Points in Zones at Risk

CEN PREN 1632- 2

Cleanroom Technology - Biocontamination Control - Part 2: Methods of Analyzing and Measuring Biocontamination of Textiles in Zones at Risk

CEN PREN 1632- 3

Cleanroom Technology - Biocontamination Control - Part 3: Basic Methods of Analyzing and Measuring Biocontamination of Surfaces in Zones at Risk

CEN PREN 1632- 4

Cleanroom Technology - Biocontamination Control - Part 4: Methods of Analyzing and Measuring Aerobiocontamination in Zones at Risk

CEN PREN 1633- 1

Cleanroom Technology - Particulate Contamination - Part 1: Classification of Cleanrooms and Clean Air Controlled Spaces By Airborne Particulate Content

CEN PREN 1874

Nomenclature - Specification for a Nomenclature System for Medical Devices for the Purpose of Regulatory Data Exchange

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)

CEN PREN ISO 11979- 5

Optics and Optical Instruments - Intraocular Lenses - Part 5: Biocompatibility

CEN PREN ISO 11979- 6

Optics and Optical Instruments - Intraocular Lenses - Part 6: Determination of Shelf-Life and Transport Stability