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  • VDI/VDE 3516 Blatt 2:1981-07

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Process analytical equipment for fluids

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  11-01-2020

    Language(s):  English, German

    Published date:  01-07-1981

    Publisher:  Verlag des Vereins Deutscher Ingenieure

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

    Preliminary note
    Introduction
    1 Scope
    2 Normative references
    3 Abbreviations
    4 Definitions of classes
    5 Exceptions - systems with
      automated calibration
    6 Mapping of classes between
      'GAMP GPG - Validation of Laboratory
      Computerized Systems' and this
      standard
    7 Requirements for life cycle
      documentation
    8 Case studies
    9 21 CFR Part 11 requirements
    Annex A - Example forms
    Annex B - Functional testing
              requirements
    Annex C - Test document structure
              example
    Annex D - Access control matrix
    Annex E - Example of a class A or
              a class B qualification
    Glossary
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes PC or higher 'computerized systems', which are capable of the described administration functions for ERES (audit trail, user management, etc.).

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

    Document Type Standard
    Publisher Verlag des Vereins Deutscher Ingenieure
    Status Withdrawn

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

    EN 61115:1993 Expression of performance of sample handling systems for process analyzers
    VDI/VDE 3516 Blatt 4:2016-04 Validation in GxP area - Automated testing

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

    DIN EN ISO 11135:2014-10 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
    EN ISO 19011:2011 COR 2011 GUIDELINES FOR AUDITING MANAGEMENT SYSTEMS (ISO 19011:2011)
    DIN EN ISO 14644-1:2016-06 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-1:2015)
    ISO 19011:2011 Guidelines for auditing management systems
    DIN EN ISO 19011:2011-12 GUIDELINES FOR AUDITING MANAGEMENT SYSTEMS (ISO 19011:2011)
    ISO/IEC 25051:2014 Software engineering Systems and software Quality Requirements and Evaluation (SQuaRE) Requirements for quality of Ready to Use Software Product (RUSP) and instructions for testing
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    PREN ISO 14644-1 : DRAFT 2010 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION
    VDI 1000:2017-02 VDI Standardisation Work - Principles and procedures
    PREN ISO 11135 : DRAFT 2011 STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO/DIS 11135:2011)
    ISO/IEC 12119:1994 Information technology Software packages Quality requirements and testing
    DIN EN ISO 11135-1:2007-08 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    DIN EN 12469:2000-09 BIOTECHNOLOGY - PERFORMANCE CRITERIA FOR MICROBIOLOGICAL SAFETY CABINETS
    EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    EN 12469:2000 Biotechnology - Performance criteria for microbiological safety cabinets
    EN ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
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