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  • EN 12306:1997

    Current The latest, up-to-date edition.

    Biotechnology - Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination

    Available format(s): 

    Language(s): 

    Published date:  21-10-1997

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 General considerations
    5 Quality control procedures
    Annex A (informative) Bibliography

    Abstract - (Show below) - (Hide below)

    This European Standard provides guidance for a quality control procedure of a diagnostic kit to assure that the assay results will fulfil the intended purpose of the test by both manufacturers and users. This European Standard applies to diagnostic kits used in agriculture, plant and animal pest and disease control monitoring of feed and environmental contamination due to microorganisms.

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

    Committee CEN/TC 233
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

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

    ISO 9004-1:1994 Quality management and quality system elements Part 1: Guidelines
    EN ISO 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
    EN ISO 9003:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR FINAL INSPECTION AND TEST
    ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
    EN ISO 9000-1 : 1994 QUALITY MANAGEMENT AND QUALITY ASSURANCE STANDARDS - PART 1: GUIDELINES FOR SELECTION AND USE (ISO 9000-1:1994)
    EN 1619:1996 Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures
    EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
    EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
    EN ISO 9004-1 : 1994 QUALITY SYSTEMS - PRINCIPAL CONCEPTS AND APPLICATIONS - GUIDE TO QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS
    ISO 9001:2015 Quality management systems — Requirements
    ISO 9003:1994 Quality systems Model for quality assurance in final inspection and test
    ISO 9000-1:1994 Quality management and quality assurance standards — Part 1: Guidelines for selection and use
    ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability
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