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  • VDI 6300 Blatt 1:2016-05

    Current The latest, up-to-date edition.

    Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities

    Available format(s):  Hardcopy, PDF

    Language(s):  German - English

    Published date:  01-05-2016

    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 Terms and definitions
    4 Requirements applicable to technical
      and analytic checks
    5 Carrying out test measures
    6 Measures in the event of safety-related
      incidents, operating problems and
      accidents (safety level 1 to safety level 3)
    Annex - Inactivation kinetics
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines the state of the art as regards checking safety measures and also sampling as well as analysis for the safe operation of genetic engineering facilities.

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

    Document Type Standard
    Publisher Verlag des Vereins Deutscher Ingenieure
    Status Current
    Supersedes

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

    DIN EN 1822-4:2011-01 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 4: DETERMINING LEAKAGE OF FILTER ELEMENTS (SCAN METHOD)
    DIN 10113-2:1997-07 Determination of surface colony count on fitment and utensils in foodareas - Part 2: Semiquantitative swab method
    BGR 134 : 2004
    EN ISO 14698-1 : 2003 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
    HD 60364-7-718:2013/A12:2017 LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 7-718: REQUIREMENTS FOR SPECIAL INSTALLATIONS OR LOCATIONS - COMMUNAL FACILITIES AND WORKPLACES
    ZH 1/343 : 1992 SICHERE BIOTECHNOLOGIE; BETRIEB - AUSSTATTUNG UND ORGANISATORISCHE MASSNAHMEN (B 003)
    DIN EN 13060:2015-03 SMALL STEAM STERILIZERS
    DIN 58356-12:2000-01 FILTER ELEMENTS - MEMBRANE FILTER ELEMENTS - PART 12: INTEGRITY TEST OF HYDROPHOBIC MEMBRANE FILTERS WITH WATER
    TRGS 522 : 2013
    HD 60364-5-56:2010/A12:2017 LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 5-56: SELECTION AND ERECTION OF ELECTRICAL EQUIPMENT - SAFETY SERVICES
    IEC 60364-5-56:2009 Low-voltage electrical installations - Part 5-56: Selection and erection of electrical equipment - Safety services
    ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
    EN ISO 11140-3:2009 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)
    DIN 10113-1:1997-07 Determination of surface colony count on fitment and utensils in foodareas - Part 1: Quantitative swab method
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    VDE 0105-100 : 2015 AMD 1 2017 OPERATION OF ELECTRICAL INSTALLATIONS - PART 100: GENERAL REQUIREMENTS
    DIN EN ISO 14644-3:2006-03 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
    DIN EN ISO 11138-3:2015-10 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES (ISO 11138-3:2017)
    VDE 0100-718 : 2014 LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 7-718: REQUIREMENTS FOR SPECIAL INSTALLATIONS OR LOCATIONS - COMMUNAL FACILITIES AND WORKPLACES
    VDI 2083 Blatt 3:2005-07 Cleanroom technology - Metrology and test methods
    VDI 2083 Blatt 1:2013-01 Cleanroom technology - Particulate air cleanliness classes
    EN 1822-5:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 5: Determining the efficiency of filter elements
    EN ISO 11138-4:2017 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)
    DIN EN 1422:2014-08 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    DIN EN 285:2016-05 Sterilization - Steam sterilizers - Large sterilizers
    VDE 0100-600 : 2017-06 LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 6: VERIFICATION (IEC 60364-6:2016)
    EN ISO 11138-3:2017 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)
    EN ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)
    ISO 11140-3:2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
    EN ISO 11138-2:2017 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017)
    DIN EN ISO 14161:2010-03 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
    DIN EN ISO 11138-2:2015-10 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES (ISO 11138-2:2017)
    PREN 285 : DRAFT 2013 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    ISO 11138-2:2017 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
    BGR 121 : 2004
    VDE 0100-560 : 2013-10 ERRICHTEN VON NIEDERSPANNUNGSANLAGEN - TEIL 5-56: AUSWAHL UND ERRICHTUNG ELEKTRISCHER BETRIEBSMITTEL - EINRICHTUNGEN FUER SICHERHEITSZWECKE (IEC 60364-5-56:2009)
    EN 61010-2-020:2017 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-020: Particular requirements for laboratory centrifuges
    EN 1822-2:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 2: Aerosol production, measuring equipment, particle counting statistics
    DIN EN ISO 17665:2004-10 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    EN ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
    EN ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
    IEC 60364-6:2016 Low voltage electrical installations - Part 6: Verification
    DIN VDE 0100-718 : 2014 LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 7-718: REQUIREMENTS FOR SPECIAL INSTALLATIONS OR LOCATIONS - COMMUNAL FACILITIES AND WORKPLACES
    IEC 60364-7-718:2011 Low-voltage electrical installations - Part 7-718: Requirements for special installations or locations - Communal facilities and workplaces
    VDI 1000:2017-02 VDI Standardisation Work - Principles and procedures
    DIN EN 1822-1:2011-01 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING
    TRGS 526 : 2008
    VDE 0411-1 : 2011 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
    ISO 11140-4:2007 Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
    ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
    DIN EN 1822-2:2011-01 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 2: AEROSOL PRODUCTION, MEASURING EQUIPMENT, PARTICLE COUNTING STATISTICS
    ASR A3.6 : 2012
    DIN EN 1822-3:2011-01 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 3: TESTING FLAT SHEET FILTER MEDIA
    DIN EN ISO 11140-4:2007-07 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)
    DIN EN 12469:2000-09 BIOTECHNOLOGY - PERFORMANCE CRITERIA FOR MICROBIOLOGICAL SAFETY CABINETS
    IEC 61010-2-020:2016 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-020: Particular requirements for laboratory centrifuges
    DIN EN ISO 11140-3:2009-09 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
    EN ISO 11140-4:2007 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)
    ASTM E 2458 : 2017 : REDLINE Standard Practices for Bulk Sample Collection and Swab Sample Collection of Visible Powders Suspected of Being Biological Agents and Toxins from Nonporous Surfaces
    DIN EN ISO 11138-1:2015-10 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
    EN 1822-3:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 3: Testing flat sheet filter media
    DIN 58949-3:2012-01 DISINFECTION - STEAM DISINFECTION APPARATUS - PART 3: EFFICIENCY TESTING
    DIN VDE 0100-600 : 2017-06 LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 6: VERIFICATION (IEC 60364-6:2016)
    DIN EN 61010-1 : 2011 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    EN 1822-1:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
    DIN 58949-2:2014-06 DISINFECTION - STEAM DISINFECTION APPARATUS - PART 2: REQUIREMENTS
    DIN 58951-2:2003-07 STERILIZATION - STEAM STERILIZERS FOR LABORATORY USE - PART 2: APPARATUS REQUIREMENTS, REQUIREMENTS ON SERVICES AND INSTALLATION
    EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    EN ISO 17665-1 : 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
    EN 12469:2000 Biotechnology - Performance criteria for microbiological safety cabinets
    DIN EN 1822-5:2011-01 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 5: DETERMINING THE EFFICIENCY OF FILTER ELEMENTS
    VDI 2083 Blatt 3.1:2012-06 Cleanroom technology - Metrology in cleanroom air - Monitoring
    ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
    BGR 500 : SEP 2008
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    ISO 11138-4:2017 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
    DIN EN ISO 11138-5:2015-10 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES (ISO 11138-5:2017)
    ISO 11138-5:2017 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
    DIN 12980:2016-10 LABORATORY INSTALLATIONS - SAFETY CABINETS AND GLOVE BOXES FOR CYTOTOXIC SUBSTANCES AND OTHER CMR DRUGS
    DIN 10113-3:1997-07 Determination of surface colony count on fitment and utensils in foodareas - Part 3: Semiquantitative method with culture media laminated taking up equipment (squeeze method)
    EN 1822-4:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 4: Determining leakage of filter elements (scan method)
    EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
    DIN EN 14180:2014-09 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    EN 13060:2014 Small steam sterilizers
    EN ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    DIN VDE 0100-560 : 2013-10 LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 5-56: SELECTION AND ERECTION OF ELECTRICAL EQUIPMENT - SAFETY SERVICES (IEC 60364-5-56:2009)
    DIN EN ISO 11138-4:2015-10 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES (ISO 11138-4:2017)
    DIN EN ISO 11140-1:2015-03 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    1997/23/EC : 1997 DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 29 MAY 1997 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING PRESSURE EQUIPMENT
    EN ISO 14644-3:2005 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
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