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  • I.S. EN 1422:2014

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    STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2014

    Publisher:  National Standards Authority of Ireland

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    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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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
    8 Packaging, marking and labelling
    9 Information to be supplied by the manufacturer
    10 Service and local environment
    Annex A (normative) - Test instrumentation
    Annex B (normative) - Leak test cycle
    Annex C (normative) - Sterilizer chamber profile testing
    Annex D (normative) - Microbiological test for EO sterilizers
    Annex E (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 the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes

    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 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
    AAMI ST41 : 2008 ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
    2006/95/EC : 2006 DIRECTIVE 2006/1995/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 12 DECEMBER 2006 ON THE HARMONISATION OF THE LAWS OF MEMBER STATES RELATING TO ELECTRICAL EQUIPMENT DESIGNED FOR USE WITHIN CERTAIN VOLTAGE LIMITS (CODIFIED VERSION) (TEXT WITH EEA RELEVANCE)
    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 (IEC 61010-2-040:2015)
    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 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 60073:2002 Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators
    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
    2004/108/EC : 2004 DIRECTIVE 2004/108/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 15 DECEMBER 2004 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ELECTROMAGNETIC COMPATIBILITY AND REPEALING DIRECTIVE 89/336/EC
    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 OF TYPE B AND TYPE S
    EN ISO 11138-2:2017 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES (ISO 11138-2:2017)
    EN ISO 10993-7 : 2008 COR 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009)
    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
    ISO 11138-2:2017 Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes
    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 (IEC 61326-1:2012)
    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
    PREN ISO 11135 : DRAFT 2011 STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO/DIS 11135:2011)
    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 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)
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    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 11203:1995 Acoustics Noise emitted by machinery and equipment Determination of emission sound pressure levels at a work station and at other specified positions from the sound power level
    ISO 9001:2015 Quality management systems Requirements
    EN ISO 12100:2010 (edition 2) 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
    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 (IEC 61010-1:2010)
    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 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    EN ISO 11203:2009 ACOUSTICS - NOISE EMITTED BY MACHINERY AND EQUIPMENT - DETERMINATION OF EMISSION SOUND PRESSURE LEVELS AT A WORK STATION AND AT OTHER SPECIFIED POSITIONS FROM THE SOUND POWER LEVEL
    EN ISO 9000 : 2015 QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015)
    1994/9/EC : 1994 DIRECTIVE 94/9/EC OF THE EUROPEAN PARLIAMENT AND THE COUNCIL OF 23 MARCH 1994 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERES
    EN 60204-1 : 2006 COR 2010 SAFETY OF MACHINERY - ELECTRICAL EQUIPMENT OF MACHINES - PART 1: GENERAL REQUIREMENTS
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