VDI 6300 Blatt 1:2016-05
Current
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
05-01-2016
Publisher
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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
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.
| DocumentType |
Standard
|
| Pages |
58
|
| PublisherName |
Verlag des Vereins Deutscher Ingenieure
|
| Status |
Current
|
| Supersedes |
| 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 (ISO 14698-1:2003) |
| 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 (ISO 14644-3:2005) |
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