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  • EN ISO 14698-2:2003/AC:2006

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 2: EVALUATION AND INTERPRETATION OF BIOCONTAMINATION DATA

    Available format(s): 

    Superseded date:  23-07-2013

    Language(s): 

    Published date:  19-04-2006

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Evaluation and interpretation of biocontamination data
    Bibliography
    Annex ZA (normative) - Normative references to international
             publications with their relevant European publications

    Abstract - (Show below) - (Hide below)

    Provides guidance on methods for the evaluation of microbiological data and the estimation of results obtained from sampling for viable particles in risk zones for biocontamination control.

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

    Committee TC 243
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    I.S. EN 13824:2005 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
    DIN EN ISO 14698-1 E : 2004 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
    BS EN 13824:2004 Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    DIN EN ISO 14698-1:2004-04 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003)
    DIN EN ISO 13408-1:2015-12 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
    BS EN ISO 13408-1:2015 Aseptic processing of health care products General requirements
    BS EN ISO 14698-1:2003 Cleanrooms and associated controlled environments. Biocontamination control General principles and methods
    I.S. EN ISO 14698-1:2003 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
    VDI 2083 Blatt 18:2012-01 Cleanroom technology - Biocontamination control
    VDI 2083 Blatt 15:2007-04 Cleanroom technology - Personnel at the clean work place
    VDI 4066 Blatt 1:2013-05 Hygienic requirements for the production and aseptically filling of beverage products - Principles and design criteria
    VDI 2083 Blatt 5.1:2007-09 Cleanroom technology - Cleanroom operation
    EN ISO 14698-1 : 2003 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
    PREN 17141 : DRAFT 2017 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
    ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
    EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
    EN 13824 : 2004 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
    I.S. EN ISO 13408-1:2015 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
    17/30329441 DC : 0 BS EN 17141 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
    DIN EN 13824:2005-02 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS

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

    EN ISO 14698-1 : 2003 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
    ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    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/TR 7871:1997 Cumulative sum charts Guidance on quality control and data analysis using CUSUM techniques
    ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability
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