• BS ISO 10651-5:2006

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Lung ventilators for medical use. Particular requirements for basic safety and essential performance Gas-powered emergency resuscitators

    Available format(s): 

    Withdrawn date:  13-08-2021

    Language(s): 

    Published date:  30-05-2008

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
      4.1 General
      4.2 Other test methods
      4.3 Acceptance criteria
    5 Constructional requirements
      5.1 General
      5.2 Connectors
    6 Operational requirements
      6.1 General
      6.2 Resistance to environmental influences
      6.3 Resistance to typical use
      6.4 Size and mass
      6.5 Gas supply
    7 Performance
      7.1 Ventilatory requirements
      7.2 Ventilation performance
    8 Identification, marking and documents
      8.1 General
      8.2 Marking
      8.3 Information provided by the manufacturer for
          operation and maintenance
    Annex A (informative) - Rationale
    Annex B (normative) - Test methods
    Annex C (informative) - Relationship between this part of
                            ISO 10651 and cardiopulmonary
                            resuscitation guidelines
    Annex D (informative) - Clauses of this part of ISO 10651
                            addressing the essential principles
    Annex E (informative) - Terminology - Index of defined
                            terms
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the basic safety and essential performance requirements for gas-powered emergency resuscitators intended for use with humans by first responders.

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

    Committee CH/121/9
    Development Note Supersedes 04/30088362 DC. (05/2008)
    Document Type Standard
    Publisher British Standards Institution
    Status Withdrawn
    Supersedes

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

    ISO/IEC TR 10000-1:1998 Information technology Framework and taxonomy of International Standardized Profiles Part 1: General principles and documentation framework
    ISO 10241:1992 International terminology standards Preparation and layout
    ISO 690:2010 Information and documentation Guidelines for bibliographic references and citations to information resources
    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
    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
    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 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
    ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
    ISO 690-2:1997 Information and documentation Bibliographic references Part 2: Electronic documents or parts thereof
    ISO 10297:2014 Gas cylinders — Cylinder valves — Specification and type testing
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
    ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
    IEC 60027-3:2002 Letter symbols to be used in electrical technology - Part 3: Logarithmic and related quantities, and their units
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
    IEC 60027-2:2005 Letter symbols to be used in electrical technology - Part 2: Telecommunications and electronics
    ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
    ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
    IEC 60027-4:2006 Letter symbols to be used in electrical technology - Part 4: Rotating electric machines
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
    ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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