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  • BS EN ISO 14698-1:2003

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Cleanrooms and associated controlled environments. Biocontamination control General principles and methods

    Available format(s):  Hardcopy, PDF

    Superseded date:  12-08-2020

    Language(s):  English

    Published date:  27-10-2003

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Principles of biocontamination control
    5 Establishing the Formal System
    6 Expression, interpretation and reporting of results
    7 Verification of the Formal System
    8 Training
    9 Documentation
    Annex A (informative) Guidance on determining airborne
            biocontamination
    Annex B (informative) Guidance on validating air samplers
    Annex C (informative) Guidance on determining biocontamination
            of surfaces
    Annex D (informative) Guidance on determining biocontamination
            of textiles
    Annex E (informative) Guidance on validating laundering processes
    Annex F (informative) Guidance on determining biocontamination of
            liquids
    Annex G (informative) Guidance on training
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the principles and basic methodology of a formal system of biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom technology is applied for that purpose.

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

    Committee LBI/30
    Development Note Supersedes 96/124833 DC. (10/2003)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    IEC 61025:2006 Fault tree analysis (FTA)
    EN ISO 14644-4:2001 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
    ISO 15161:2001 Guidelines on the application of ISO 9001:2000 for the food and drink industry
    ISO 7218:2007 Microbiology of food and animal feeding stuffs General requirements and guidance for microbiological examinations
    ISO 14698-2:2003 Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data
    IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    EN ISO 14698-2:2003/AC:2006 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 2: EVALUATION AND INTERPRETATION OF BIOCONTAMINATION DATA
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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