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  • DIN EN 14180:2014-09

    Current The latest, up-to-date edition.

    STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING

    Available format(s):  Hardcopy, PDF

    Language(s):  German

    Published date:  01-09-2014

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

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

    National foreword
    National Annex NA (informative) - Bibliography
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Technical requirements
    5 Process control
    6 Performance requirements
    7 Sound power and vibration
    8 Packaging, marking and labelling
    9 Information to be supplied by the
       manufacturer
    10 Service and local environment
    Annex A (normative) - Test methods
    Annex B (normative) - Sterilizer classification
            and testing
    Annex C (normative) - Test equipment
    Annex D (normative) - Determination of formaldehyde
            residuals in a filter indicator
    Annex E (informative) - Formaldehyde residues on
            medical devices
    Annex F (informative) - Environmental aspects
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC
             on medical devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    This standard is included in DIN Handbook 169.

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

    Committee TC 102
    Development Note Supersedes DIN 58948-12 and DIN 58948-13 Together with DIN 58948-17 supersedes DIN 58948-15 (10/2003)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current
    Supersedes

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

    VDI 6300 Blatt 1:2016-05 Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering 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
    EN 61508-3:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements
    DIN ISO 8787:1994-06 TESTING OF PAPER AND BOARD - DETERMINATION OF CAPILLARY RISE - KLEMM METHOD
    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
    ISO 1874-1:2010 Plastics Polyamide (PA) moulding and extrusion materials Part 1: Designation system and basis for specification
    EN 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements
    EN 10027-2:2015 DESIGNATION SYSTEMS FOR STEELS - PART 2: NUMERICAL SYSTEM
    EN 60584-2:1993 Thermocouples - Part 2: Tolerances
    DIN ISO 3781:2012-07 Paper and board - Determination of tensile strength after immersion in water (ISO 3781:2011)
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    EN ISO 1874-1:2010 Plastics - Polyamide (PA) moulding and extrusion materials - Part 1: Designation system and basis for specification (ISO 1874-1:2010)
    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 868-5:2009 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
    EN 1837:1999+A1:2009 Safety of machinery - Integral lighting of machines
    IEC 60204-1:2016 Safety of machinery - Electrical equipment of machines - Part 1: General requirements
    ISO 1762:2015 Paper, board and pulps Determination of residue (ash) on ignition at 525 degrees C
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 2758:2014 Paper Determination of bursting strength
    ISO 4017:2014 Fasteners Hexagon head screws Product grades A and B
    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
    IEC 61508-3:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508)
    ISO 25424:2009 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
    EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
    ISO 12100:2010 Safety of machinery — General principles for design — Risk assessment and risk reduction
    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)
    EN ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
    ISO 8787:1986 Paper and board — Determination of capillary rise — Klemm method
    EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
    EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
    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
    EN ISO 536:2012 Paper and board - Determination of grammage (ISO 536:2012)
    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
    AAMI RD47 : 2008 REPROCESSING OF HEMODIALYZERS
    ISO 3781:2011 Paper and board — Determination of tensile strength after immersion in water
    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)
    ISO 13849-2:2012 Safety of machinery — Safety-related parts of control systems — Part 2: Validation
    ISO 536:2012 Paper and board Determination of grammage
    IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
    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 2758:2014 Paper - Determination of bursting strength (ISO 2758:2014)
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    EN ISO 13849-2:2012 Safety of machinery - Safety-related parts of control systems - Part 2: Validation (ISO 13849-2:2012)
    ISO 534:2011 Paper and board — Determination of thickness, density and specific volume
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    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
    IEC 62061:2005+AMD1:2012+AMD2:2015 CSV Safety of machinery - Functional safety of safety-related electrical, electronic and programmable electronic control systems
    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
    ISO 11138-5:2017 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
    EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
    ISO 228-1:2000 Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation
    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)
    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 ISO 534:2011 Paper and board - Determination of thickness, density and specific volume (ISO 534:2011)
    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 60204-1 : 2006 COR 2010 SAFETY OF MACHINERY - ELECTRICAL EQUIPMENT OF MACHINES - PART 1: GENERAL REQUIREMENTS
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