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  • BS EN ISO 15001:2011

    Current The latest, up-to-date edition.

    Anaesthetic and respiratory equipment. Compatibility with oxygen

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-11-2011

    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 Cleanliness
    5 Resistance to ignition
    6 Risk management
    Annex A (informative) - Examples of cleaning procedures
    Annex B (informative) - Typical methods for validation of
            cleaning procedures
    Annex C (informative) - Design considerations
    Annex D (informative) - Selection of materials
    Annex E (informative) - Recommended method for combustion
            and quantitative analysis of combustion products of
            non-metallic materials
    Annex F (informative) - Rationale
    Bibliography
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Defines requirements for the oxygen compatibility of materials, components and devices for anaesthetic and respiratory applications, which can come into contact with oxygen in normal condition or in single fault condition at gas pressures greater than 50 kPa.

    Scope - (Show below) - (Hide below)

    This International Standard specifies requirements for the oxygen compatibility of materials, components and devices for anaesthetic and respiratory applications, which can come into contact with oxygen in normal condition or in single fault condition at gas pressures greater than 50kPa.

    Additionally, this International Standard gives general guidelines for the selection of materials and components based on available data on their oxygen compatibility, and for carrying out a risk analysis, including addressing the toxicity of products of combustion and/or decomposition.

    Aspects of compatibility that are addressed by this International Standard include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition at the design, manufacturing, maintenance and disposal stages.

    This International Standard does not apply to biocompatibility.

    This International Standard is applicable to anaesthetic and respiratory equipment that is within the scope of ISO/TC121, e.g. medical gas pipeline systems, pressure regulators, terminal units, medical supply units, flexible connections, flow-metering devices, anaesthetic workstations and lung ventilators.

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

    Committee CH/121/6
    Development Note Renumbers and supersedes BS ISO 15001. Supersedes 98/564339 DC. 2004 version incorporates amendment 15145 to BS ISO 15001. (06/2004)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    ISO 4589-3:2017 Plastics — Determination of burning behaviour by oxygen index — Part 3: Elevated-temperature test
    ISO 11114-1:2012 Gas cylinders Compatibility of cylinder and valve materials with gas contents Part 1: Metallic materials
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 10298:2010 Determination of toxicity of a gas or gas mixture
    ASTM G 88 : 2013 : REDLINE Standard Guide for Designing Systems for Oxygen Service
    ASTM G 122 : 1996 Standard Test Method for Evaluating the Effectiveness of Cleaning Agents
    NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
    ASTM G 72 : 2001 Standard Test Method for Autogenous Ignition Temperature of Liquids and Solids in a High-Pressure Oxygen-Enriched Environment
    ISO 11114-3:2010 Gas cylinders Compatibility of cylinder and valve materials with gas contents Part 3: Autogenous ignition test for non-metallic materials in oxygen atmosphere
    BS 6869:1987 Code of practice for procedures for ensuring the cleanliness of industrial-process measurement and control equipment in oxygen service
    ISO 21969:2009 High-pressure flexible connections for use with medical gas systems
    ASTM G 114 : 2014 : REDLINE Standard Practices for Evaluating the Age Resistance of Polymeric Materials Used in Oxygen Service
    ISO 10297:2014 Gas cylinders — Cylinder valves — Specification and type testing
    ISO 7291:2010 Gas welding equipment Pressure regulators for manifold systems used in welding, cutting and allied processes up to 30 MPa (300 bar)
    ASTM G 175 : 2013 : REDLINE Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Pressure Regulators Used for Medical and Emergency Applications
    ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
    ASTM G 131 : 1996 Standard Practice for Cleaning of Materials and Components by Ultrasonic Techniques
    ASTM G 127 : 2015 : REDLINE Standard Guide for the Selection of Cleaning Agents for Oxygen-Enriched Systems
    ASTM G 86 : 1998 : REV A Standard Test Method for Determining Ignition Sensitivity of Materials to Mechanical Impact in Ambient Liquid Oxygen and Pressurized Liquid and Gaseous Oxygen Environments
    ASTM G 4 : 2001 Standard Guide for Conducting Corrosion Tests in Field Applications
    ASTM G 63 : 2015 : REDLINE Standard Guide for Evaluating Nonmetallic Materials for Oxygen Service
    ISO 4589-2:2017 Plastics — Determination of burning behaviour by oxygen index — Part 2: Ambient-temperature test
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 13348:2016 Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum
    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
    ASTM G 74 : 2013 : REDLINE Standard Test Method for Ignition Sensitivity of Nonmetallic Materials and Components by Gaseous Fluid Impact
    CGA V 9 : 2012 COMPRESSED GAS CYLINDER VALVES
    ISO 19701:2013 Methods for sampling and analysis of fire effluents
    ISO 4589-1:2017 Plastics — Determination of burning behaviour by oxygen index — Part 1: General requirements
    ASTM G 120 : 2015 : REDLINE Standard Practice for Determination of Soluble Residual Contamination by Soxhlet Extraction
    ISO 10524-2:2005 Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators
    ASTM G 126 : 2016 : REDLINE Standard Terminology Relating to the Compatibility and Sensitivity of Materials in Oxygen Enriched Atmospheres
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