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  • PREN 17180 : DRAFT 2017

    Current The latest, up-to-date edition.

    STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING

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    Language(s): 

    Published date:  09-01-2018

    Publisher:  Comite Europeen de Normalisation

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

    European foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Mechanical components and assemblies
    5 Instrumentation, indicating and recording devices
    6 Control systems
    7 Performance requirements
    8 Safety, Risk control and usability
    9 Packaging, marking and labelling
    10 Information to be supplied by the manufacturer
    11 Services and local environment
    Annex A (informative) - Sterilizer classification and test
            programme
    Annex B (normative) - Test equipment
    Annex C (normative) - Test loads
    Annex D (normative) - Test procedures
    Annex E (informative) - Measurement of hydrogen peroxide
    Annex F (informative) - H2O2 residues on medical devices
    Annex G (normative) - Protective measures
    Annex H (informative) - Environmental aspects
    Annex ZA (informative) - Relationship between this European
             Standard and the essential requirements of
             Directive 93/42/EEC [OJ L 169] aimed to be
             covered
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives requirements and tests for low temperature hydrogen peroxide sterilizers, which use a vaporized aqueous solution of hydrogen peroxide as the sterilizing agent.

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

    Committee TC 102
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

    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 ISO 4287:1998/A1:2009 GEOMETRICAL PRODUCT SPECIFICATIONS (GPS) - SURFACE TEXTURE: PROFILE METHOD - TERMS, DEFINITIONS AND SURFACE TEXTURE PARAMETERS
    EN 61508-3:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements
    ISO 4287:1997 Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters
    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)
    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 10027-2:2015 DESIGNATION SYSTEMS FOR STEELS - PART 2: NUMERICAL SYSTEM
    EN 10216-5:2013 Seamless steel tubes for pressure purposes - Technical delivery conditions - Part 5: Stainless steel tubes
    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    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
    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
    IEC 60204-1:2016 Safety of machinery - Electrical equipment of machines - Part 1: General requirements
    EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
    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 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 2758:2014 Paper Determination of bursting strength
    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
    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 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
    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 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
    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 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 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 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    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 2861:2013 Vacuum technology Dimensions of clamped-type quick-release couplings
    AAMI RD47 : 2008 REPROCESSING OF HEMODIALYZERS
    ISO 3781:2011 Paper and board — Determination of tensile strength after immersion in water
    ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
    EN 60584-1:2013 Thermocouples - Part 1: EMF specifications and tolerances
    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
    EN ISO 3740:2000 ACOUSTICS - DETERMINATION OF SOUND POWER LEVELS OF NOISE SOURCES - GUIDELINES FOR THE USE OF BASIC STANDARDS
    ISO 536:2012 Paper and board Determination of grammage
    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 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)
    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
    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
    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 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
    EN 13060:2014 Small steam sterilizers
    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)
    EN 60204-1 : 2006 COR 2010 SAFETY OF MACHINERY - ELECTRICAL EQUIPMENT OF MACHINES - PART 1: GENERAL REQUIREMENTS
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