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  • DIN EN 285:2016-05

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Sterilization - Steam sterilizers - Large sterilizers

    Available format(s):  Hardcopy, PDF

    Superseded date:  28-01-2022

    Language(s):  English, German

    Published date:  01-05-2016

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    Development Note Supersedes DIN 58946-2 and -3. (08/2002) Supersedes DIN 58946-7 issue 08-1982. (09/2004)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    Supersedes

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

    VDI 5700 Blatt 1:2015-04 Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control
    VDI 2050 Blatt 4:2011-11 Requirements for mechanical equipment rooms - Ventilation and air-conditioning
    VDI 2083 Blatt 9.2:2017-01 Cleanroom technology - Consumables in the cleanroom
    VDI 6300 Blatt 1:2016-05 Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities
    VDI 2083 Blatt 7:2015-10 Cleanroom technology - Ultrapure media - Quality, supply, distribution
    DIN 58946-6:2002-04 STERILIZATION - STEAM STERILIZERS - PART 6: OPERATING OF LARGE STERILIZERS IN HEALTH CARE FACILITIES
    DIN HDBK 169 : 6ED 2015

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

    IEC 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
    EN 547-2:1996+A1:2008 Safety of machinery - Human body measurements - Part 2: Principles for determining the dimensions required for access openings
    EN 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
    EN 13445-5 : 2014 COR 2017 UNFIRED PRESSURE VESSELS - PART 5: INSPECTION AND TESTING
    EN 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements
    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)
    ISO 13408-2:2003 Aseptic processing of health care products Part 2: Filtration
    ISO 13732-1:2006 Ergonomics of the thermal environment — Methods for the assessment of human responses to contact with surfaces — Part 1: Hot surfaces
    EN 1837:1999+A1:2009 Safety of machinery - Integral lighting of machines
    EN 10088-3:2014 Stainless steels - Part 3: Technical delivery conditions for semi-finished products, bars, rods, wire, sections and bright products of corrosion resisting steels for general purposes
    ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
    IEC 60204-1:2016 Safety of machinery - Electrical equipment of machines - Part 1: General requirements
    ISO 14738:2002 Safety of machinery — Anthropometric requirements for the design of workstations at machinery
    EN 547-1:1996+A1:2008 Safety of machinery - Human body measurements - Part 1: Principles for determining the dimensions required for openings for whole body access into machinery
    EN 764-1:2015+A1:2016 Pressure equipment - Part 1: Vocabulary
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 3740:2000 Acoustics Determination of sound power levels of noise sources Guidelines for the use of basic standards
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    ISO 4017:2014 Fasteners Hexagon head screws Product grades A and B
    EN 1717:2000 Protection against pollution of potable water in water installations and general requirements of devices to prevent pollution by backflow
    EN 867-5:2001 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
    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 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
    EN 10088-2:2014 STAINLESS STEELS - PART 2: TECHNICAL DELIVERY CONDITIONS FOR SHEET/PLATE AND STRIP OF CORROSION RESISTING STEELS FOR GENERAL PURPOSES
    ISO 12100:2010 Safety of machinery — General principles for design — Risk assessment and risk reduction
    CEN ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009)
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    EN 13445-8 : 2014 COR 2017 UNFIRED PRESSURE VESSELS - PART 8: ADDITIONAL REQUIREMENTS FOR PRESSURE VESSELS OF ALUMINIUM AND ALUMINIUM ALLOYS
    EN ISO 13732-1:2008 Ergonomics of the thermal environment - Methods for the assessment of human responses to contact with surfaces - Part 1: Hot surfaces (ISO 13732-1:2006)
    EN ISO 228-1:2003 Pipe threads where pressure-tight joints are not made on the threads - Part 1: Dimensions, tolerances and designation (ISO 228-1:2000)
    ISO 8573-1:2010 Compressed air Part 1: Contaminants and purity classes
    EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
    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
    EN 13445-4 : 2014 COR 2017 UNFIRED PRESSURE VESSELS - PART 4: FABRICATION
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    EN 764-7:2002/AC:2006 PRESSURE EQUIPMENT - PART 7: SAFETY SYSTEMS FOR UNFIRED PRESSURE EQUIPMENT
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO 3746:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane
    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
    EN ISO 3746:2010 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010)
    EN 60751:2008 INDUSTRIAL PLATINUM RESISTANCE THERMOMETERS AND PLATINUM TEMPERATURE SENSORS
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    EN 22768-1:1993 General tolerances - Part 1: Tolerances for linear and angular dimensions without individual tolerance indications (ISO 2768-1:1989)
    EN 60584-1:2013 Thermocouples - Part 1: EMF specifications and tolerances
    EN 547-3:1996+A1:2008 Safety of machinery - Human body measurements - Part 3: Anthropometric data
    EN 62061:2005/A2:2015 SAFETY OF MACHINERY - FUNCTIONAL SAFETY OF SAFETY-RELATED ELECTRICAL, ELECTRONIC AND PROGRAMMABLE ELECTRONIC CONTROL SYSTEMS (IEC 62061:2005/A2:2015)
    EN 61032:1998 Protection of persons and equipment by enclosures - Probes for verification
    EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
    EN ISO 3740:2000 ACOUSTICS - DETERMINATION OF SOUND POWER LEVELS OF NOISE SOURCES - GUIDELINES FOR THE USE OF BASIC STANDARDS
    2014/68/EU : 2014 COR 1 2015 DIRECTIVE 2014/68/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 15 MAY 2014 ON THE HARMONISATION OF THE LAWS OF THE MEMBER STATES RELATING TO THE MAKING AVAILABLE ON THE MARKET OF PRESSURE EQUIPMENT TEXT WITH EEA RELEVANCE
    IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
    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)
    EN ISO 4017:2014 Fasteners - Hexagon head screws - Product grades A and B (ISO 4017:2014)
    EN ISO 12100:2010 Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO 12100:2010)
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    EN 61140:2016 Protection against electric shock - Common aspects for installation and equipment
    EN ISO 14050:2010 Environmental management - Vocabulary (ISO 14050:2009)
    EN ISO 15883-1:2009/A1:2014 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006/AMD 1:2014)
    EN 14222:2003 Stainless steel shell boilers
    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)
    IEC 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (see Functional Safety and IEC 61508)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    IEC 62061:2005+AMD1:2012+AMD2:2015 CSV Safety of machinery - Functional safety of safety-related electrical, electronic and programmable electronic control systems
    IEC 61140:2016 Protection against electric shock - Common aspects for installation and equipment
    IEC 61032:1997 Protection of persons and equipment by enclosures - Probes for verification
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    IEC 60584-1:2013 Thermocouples - Part 1: EMF specifications and tolerances
    EN 60770-1:2011 Transmitters for use in industrial-process control systems - Part 1: Methods for performance evaluation
    ISO 228-1:2000 Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation
    EN ISO 14738:2008 Safety of machinery - Anthropometric requirements for the design of workstations at machinery (ISO 14738:2002, including Cor 1:2003 and Cor 2:2005)
    EN 13060:2014 Small steam sterilizers
    ISO 14050:2009 Environmental management Vocabulary
    EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
    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
    EN 60204-1 : 2006 COR 2010 SAFETY OF MACHINERY - ELECTRICAL EQUIPMENT OF MACHINES - PART 1: GENERAL REQUIREMENTS
    IEC 60770-1:2010 Transmitters for use in industrial-process control systems - Part 1: Methods for performance evaluation
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