• AAMI ISO 10651-5 : 2006

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS

    Available format(s):  Hardcopy, PDF

    Superseded date:  15-06-2020

    Language(s):  English

    Published date:  01-01-2006

    Publisher:  Association for the Advancement of Medical Instrumentation

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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
    5 Constructional requirements
    6 Operational requirements
    7 Performance
    8 Identification, marking and documents
    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 ISO/TC 121/SC 3
    Development Note Issued by AAMI in January 2015. (01/2015)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

    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
    CGA C 9 : 2013 STANDARD COLOR MARKING OF COMPRESSED GAS CONTAINERS FOR MEDICAL USE
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    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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