Skip to content
Please enter a keyword to search
  • Preview

    I.S. EN ISO 14698-1:2003

    View superseded by
    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
    View superseded by

    CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  28-02-2021

    Language(s):  English

    Published date:  06-11-2003

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

    Add To Cart

    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)

    Establishes 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)

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Withdrawn
    Superseded By

    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
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective