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  • ISO 5362:2006

    Current The latest, up-to-date edition.

    Anaesthetic reservoir bags

    Available format(s):  PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users, Hardcopy

    Language(s):  English, French, Russian

    Published date:  22-05-2006

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 5362:2006 specifies requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems. It includes requirements for the design of the neck, size designation, distension and, where relevant, for electrical resistance.

    ISO 5362:2006 includes requirements for both single-use and reusable bags. Reusable bags are intended to comply with the requirements of ISO 5362:2006 for the recommended product life.

    ISO 5362:2006 is not applicable to special-purpose bags, for example bellows and self-expanding bags.

    Bags for use with anaesthetic gas scavenging systems are not considered to be anaesthetic reservoir bags and are thus outside the scope of ISO 5362:2006.

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

    Development Note Supersedes ASTM F 1204 (01/2006) Supersedes ISO/DIS 5362 (05/2006)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    01/560793 DC : DRAFT FEB 2001 IEC/DIS 60601-2-13 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ANAESTHETIC SYSTEMS
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    03/103294 DC : DRAFT JAN 2003 BS EN ISO 10651-6 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME CARE VENTILATORY SUPPORT DEVICES
    BS EN 60601-2-13:2006 Medical electrical equipment Particular requirements for the safety and essential performance of anaesthetic systems
    CSA Z10651.6 : 2006 : R2015 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
    CSA Z10651.6 :2006 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
    I.S. EN 60601-2-12:2006 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
    BS EN ISO 80601-2-13:2012+A2:2019 Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation
    DIN EN ISO 15883-2:2009-09 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
    ISO 15883-2:2006 Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
    NF EN ISO 10651-6 : 2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
    EN ISO 80601-2-13:2012 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
    BS EN ISO 80601-2-13:2012 Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation
    UNI EN ISO 5367 : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
    BS EN 60601-2-12:2006 Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators
    CSA Z15883-5:2009 WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY
    I.S. EN 60601-2-13:2006 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS
    AAMI ISO 5367 : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
    ANSI/AAMI/ISO 16142-1:2016 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
    NF EN 60601 2-13 : 2007 AMD 1 2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS
    BS EN ISO 5367:2014 Anaesthetic and respiratory equipment. Breathing sets and connectors
    UNE-EN ISO 5367:2015 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
    ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
    DIN EN ISO 8835-2:2009-08 INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS
    BS EN ISO 15883-2:2009 Washer-disinfectors Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
    UNE-EN ISO 80601-2-13:2013 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
    BS EN ISO 8835-2:2009 Inhalational anaesthesia systems Anaesthetic breathing systems (ISO 8835-2:2007)
    I.S. EN ISO 15883-2:2009 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
    DIN EN ISO 10651-2:2011-06 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    I.S. EN ISO 8835-2:2009 INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS
    BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    CSA Z10651.6 : 2006 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
    CEI EN 60601-2-12 : 2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
    I.S. CEN ISO TS 15883-5:2006 WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY
    CEN ISO/TS 15883-5:2005 Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 15883-5:2005)
    I.S. EN ISO 80601-2-13:2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION (ISO 80601-2-13:2011)
    CSA Z8835.2 : 2008 INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS FOR ADULTS
    DIN EN ISO 10651-6:2011-06 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
    ISO 8835-2:2007 Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems
    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
    UNI EN ISO 10651-2 : 2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR- DEPENDENT PATIENTS
    UNI EN ISO 15883-2 : 2009 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER- DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
    UNI EN ISO 10651-6 : 2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
    UNI EN ISO 8835-2 : 2009 INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS
    CSA Z15883-5:09 (R2019) Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (Adopted ISO/TS 15883-5:2005, first edition, 2005-11-15)
    BS ISO 8835-2:1999 Inhalational anaesthesia systems Anaesthetic breathing systems for adults
    03/103293 DC : DRAFT JAN 2003 BS EN ISO 10651-2 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    CSA Z10651.2 : 2006 : R2015 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    CSA Z10651.2: 2006 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    BS EN ISO 10651-6:2009 Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home-care ventilatory support devices
    ANSI/AAMI ST15883-2:2013(R2015) (ISO 15883-2:2006 MOD) WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
    BS EN ISO 10651-2:2004 Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home care ventilators for ventilator-dependent patients
    ISO 10651-6:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
    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
    ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
    ISO 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
    UNI EN ISO 80601-2-13 : 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION
    EN ISO 10651-2:2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)
    EN ISO 15883-2:2009 Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)
    EN ISO 10651-6:2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)
    EN ISO 5367:2014 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
    EN ISO 8835-2:2009 Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)
    I.S. EN ISO 10651-2:2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    DIN EN ISO 5367:2015-02 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
    I.S. EN ISO 5367:2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)
    BS 7734:1994 Specification for anaesthetic circle breathing systems
    CSA Z15883-2 : 2009 : R2014 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
    DIN EN ISO 5367 E : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)
    AAMI ST15883-2 : 2013 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
    CSA Z15883-2 : 2009 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
    CSA Z15883-5 : 2009 : R2014 WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY
    CEI EN 60601-2-13 : 2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS
    EN 60601-2-13 : 2006 AMD 1 2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS
    EN 60601-2-12:2006 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators

    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"
    ISO 4287:1997 Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    EN 980:2008 Symbols for use in the labelling of medical devices
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