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CAN/CSA-Z15001:12 (R2017)

Current
Current

The latest, up-to-date edition.

Anaesthetic and respiratory equipment - Compatibility with oxygen (Adopted ISO 15001:2010, second edition, 2010-06-01, with Canadian deviations)
Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

01-01-2012

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

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 50 kPa.

Preface This is the first edition of CAN/CSA-Z15001, Anaesthetic and respiratory equipment - Compatibility with oxygen, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 15001 (second edition, 2010-06-01). Scope 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 50 kPa. 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/TC 121, e.g. medical gas pipeline systems, pressure regulators, terminal units, medical supply units, flexible connections, flow-metering devices, anaesthetic workstations and lung ventilators.

DocumentType
Standard
ISBN
978-1-55491-902-4
Pages
0
ProductNote
Reconfirmed EN
PublisherName
Canadian Standards Association
Status
Current
Supersedes

Standards Relationship
ISO 15001:2010 Identical

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
EN 13448:2001+A1:2009 Agricultural and forestry machinery - Inter-row mowing units - Safety
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 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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