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  • EN 14180:2014

    Current The latest, up-to-date edition.

    Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

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    Language(s): 

    Published date:  21-05-2014

    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)

    This European Standard specifies 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.These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.This European Standard specifies minimum requirements: - for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; - for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.

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

    Committee CEN/TC 102
    Development Note Supersedes PREN 14180. (06/2014)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current
    Supersedes

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

    AAMI ISO 11607-1 : 2006 : R2010 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
    UNI 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
    I.S. EN 15424:2007 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    14/30255135 DC : 0 BS EN ISO 11607-1:2009/A1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
    PREN ISO 11140-1 : DRAFT 2012 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO/DIS 11140-1:2012)
    ANSI/AAMI/ISO 11138-5:2017 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES
    CAN/CSA-ISO 11138-5:17 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (Adopted ISO 11138-5:2017, second edition, 2017-03)
    CSA Z15882 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    17/30351717 DC : 0 BS EN ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
    05/30066638 DC : DRAFT OCT 2005 EN 15424 - STERILIZATION OF MEDICAL DEVICES - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF STERILIZATION PROCESSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE
    CSA Z11140.1 : 2007 : R2012 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    AAMI ISO 11607-1 : 2006 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
    I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
    I.S. 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
    BS EN 868-5:2009 Packaging for terminally sterilized medical devices Sealable pouches and reels of porous and plastic film construction. Requirements and test methods
    UNE-EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)
    DIN EN ISO 11140-1:2015-03 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    BS EN ISO 11138-5:2017 Sterilization of health care products. Biological indicators Biological indicators for low-temperature steam and formaldehyde sterilization processes
    BS EN ISO 11140-1:2014 Sterilization of health care products. Chemical indicators General requirements
    BS EN 15424:2007 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
    DIN EN ISO 15882:2008-12 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    EN ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    CEN Guide 4:2008 GUIDE FOR ADDRESSING ENVIRONMENTAL ISSUES IN PRODUCT STANDARDS
    DIN EN 15424:2007-08 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
    I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    17/30360908 DC : 0 BS EN 868-5 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
    13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
    12/30238553 DC : 0 BS EN ISO 11140-1 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    DIN EN 868-5:2009-09 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
    ISO Guide 64:2008 Guide for addressing environmental issues in product standards
    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
    NF 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 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
    I.S. EN ISO 11140-1:2014 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11140-1:2014)
    I.S. 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)
    I.S. EN ISO 15882:2008 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    VDI 6300 Blatt 1:2016-05 Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities
    15/30317874 DC : 0 BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    DIN EN ISO 11607-1:2014-11 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014)
    UNI 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
    17/30338806 DC : 0 BS EN ISO 25424 - STERILIZATION OF HEALTH CARE PRODUCTS - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    AAMI ISO 15882 : 2008 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    UNE-EN 16372:2015 Aesthetic surgery services
    CSA Z15882:09 (R2019) Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (Adopted ISO 15882:2008, second edition, 2008-09-01)
    07/30166933 DC : DRAFT AUG 2007 BS EN 868-5 - PACKAGING MATERIALS FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
    I.S. 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
    EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
    BS EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems
    UNE-EN ISO 11140-1:2015 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    UNI EN ISO 15882 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    CSA ISO 11607-1 : 2016 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
    DIN EN ISO 25424:2011-09 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    PREN 17180 : DRAFT 2017 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING
    BS 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
    CSA Z15882 :2009 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    ANSI/AAMI/ISO 11607-1:2006/(R)2015 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
    15/30321514 DC : 0 BS EN ISO 11138-5 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES
    CSA Z11140.1 : 2007 : R2012 : FR STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    CSA Z11140.1 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    UNI EN ISO 11607-1 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
    BS EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems
    ANSI/AAMI/ISO 15882:2008(R2013) STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    ISO 11138-5:2017 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
    BS EN ISO 15882:2008 Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results
    EN 16372:2014 Aesthetic surgery services
    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 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
    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 ISO 15882:2008 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008)
    BS EN 16372:2014 Aesthetic surgery services
    07/30156704 DC : DRAFT DEC 2007 BS ISO GUIDE 64 - GUIDE FOR ADDRESSING ENVIRONMENTAL ISSUES IN PRODUCT STANDARDS
    PREN 868-5 : DRAFT 2017 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
    I.S. EN ISO 11607-1:2017 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006, INCLUDING AMD 1:2014)
    BS EN ISO 11607-1 : 2009 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
    CSA ISO 11140-1 : 2016 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    UNE-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)
    BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    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)
    UNE-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 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements

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    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
    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
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    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
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    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
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    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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