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  • PREN 14180 : DRAFT 2012

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING

    Available format(s): 

    Superseded date:  01-05-2014

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

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

    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)

    Describes requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.

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

    Comment Closes On
    Committee TC 102
    Document Type Draft
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

    National Adoptions - (Show below) - (Hide below)

    Equivalent Standard(s) Relationship
    12/30262894 DC : 0 Identical

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

    03/108542 DC : DRAFT MAY 2003 BS EN ISO 11140-1 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS

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

    IEC 61672-2:2013+AMD1:2017 CSV Electroacoustics - Sound level meters - Part 2: Pattern evaluation 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)
    AAMI ST41 : 2008 ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    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 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements
    EN 60584-2:1993 Thermocouples - Part 2: Tolerances
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    IEC 60073:2002 Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators
    EN 61672-2:2013/A1:2017 ELECTROACOUSTICS - SOUND LEVEL METERS - PART 2: PATTERN EVALUATION TESTS (IEC 61672-2:2013/A1:2017)
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    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 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    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
    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
    EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
    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 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
    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)
    EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
    EN 868-3:2017 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
    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 61672-1:2013 Electroacoustics - Sound level meters - Part 1: Specifications
    EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
    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 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 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
    ISO 9001:2015 Quality management systems — Requirements
    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)
    EN ISO 13849-1:2015 Safety of machinery - Safety-related parts of control systems - Part 1: General principles for design (ISO 13849-1:2015)
    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
    EN ISO 10012:2003 Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003)
    IEC 62061:2005+AMD1:2012+AMD2:2015 CSV Safety of machinery - Functional safety of safety-related electrical, electronic and programmable electronic control systems
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    CEN ISO/TS 11135-2:2008/AC:2009 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
    ISO 13849-1:2015 Safety of machinery — Safety-related parts of control systems — Part 1: General principles for design
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO 11138-5:2017 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
    EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - 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)
    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
    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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