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  • CEI EN 60601-2-12 : 2007

    Current The latest, up-to-date edition.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS

    Available format(s):  Hardcopy, PDF

    Language(s):  English - Italian

    Published date:  01-01-2007

    Publisher:  Comitato Elettrotecnico Italiano

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

    INTRODUCTION
    SECTION ONE - GENERAL
    SECTION TWO - ENVIRONMENTAL
                  CONDITIONS
    SECTION THREE - PROTECTION
                    AGAINST ELECTRIC
                    SHOCK HAZARDS
    SECTION FOUR - PROTECTION
                   AGAINST MECHANICAL
                   HAZARDS
    SECTION FIVE - PROTECTION
                   AGAINST HAZARDS
                   FROM UNWANTED OR
                   EXCESSIVE RADIATION
    SECTION SIX - PROTECTION AGAINST
                  HAZARDS OF IGNITION
                  OF FLAMMABLE
                  ANAESTHETIC MIXTURES
    SECTION SEVEN - PROTECTION
                    AGAINST EXCESSIVE
                    TEMPERATURES AND
                    OTHER SAFETY HAZARDS
    SECTION EIGHT - ACCURACY OF
                    OPERATING DATA
                    AND PROTECTION AGAINST
                    HAZARDOUS OUTPUT
    SECTION NINE - ABNORMAL OPERATION
                   AND FAULT CONDITIONS;
                   ENVIRONMENTAL TESTS
    SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
    Appendix L References - Publications
                            mentioned in this
                            standard
    Annex AA (informative) - Rationale
    Annex BB (normative) - Legibility
              and visibility of visual
              indications
    Annex CC (informative) - Intelligent
             alarm systems
    Bibliography
    Terminology - Index of defined terms
    Annex ZA (normative) - Normative
             references to international
             publications with their
             corresponding European
             publications
    Annex ZB (informative) - References
             to international publications
             with their corresponding
             European publications
    Annex ZZ (informative) - Coverage
             of Essential Requirements
             of EC Directives

    Abstract - (Show below) - (Hide below)

    Specifies the safety requirements for VENTILATORS, intended for use in critical care settings.

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

    Committee CT 62
    Development Note Classificazione CEI 62-141. (12/2006)
    Document Type Standard
    Publisher Comitato Elettrotecnico Italiano
    Status Current

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

    EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    ISO 8835-3:2007 Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
    ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
    ISO 9703-1:1992 Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals
    IEC 60416:1988 General principles for the formulation of graphical symbols
    IEC 60417-1:2002 Graphical symbols for use on equipment - Part 1: Overview and application
    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 10651-2:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients
    ISO 7767:1997 Oxygen monitors for monitoring patient breathing mixtures — Safety requirements
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    ISO 9703-3:1998 Anaesthesia and respiratory care alarm signals Part 3: Guidance on application of alarms
    NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
    EN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    ISO 9918:1993 Capnometers for use with humans Requirements
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    ISO 11138-2:2017 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
    ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    ISO 5362:2006 Anaesthetic reservoir bags
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 10651-3:1997 Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilators
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    ISO 7396:1987 Non-flammable medical gas pipeline systems
    IEC 60601-2-13:2003+AMD1:2006 CSV Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    IEC 60417-2:1998 Graphical symbols for use on equipment - Part 2: Symbol originals
    ISO 9919:2005 Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
    ISO 9360-1:2000 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
    CEI 62-5 : 1ED 1980
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 60601-1-4:1996/A1:1999 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 9360-2:2001 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
    ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
    ISO 11195:1995 Gas mixers for medical use Stand-alone gas mixers
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
    ISO 9703-2:1994 Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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