UNI EN ISO 15001 : 2012
Current
The latest, up-to-date edition.
ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN
02-02-2012
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
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
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.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| BS EN ISO 15001:2011 | Identical |
| NBN EN ISO 15001 : 2011 | Identical |
| DIN EN ISO 15001:2012-06 | Identical |
| NEN EN ISO 15001 : 2011 | Identical |
| ISO 15001:2010 | Identical |
| EN ISO 15001:2011 | Identical |
| I.S. EN ISO 15001:2011 | Identical |
| SN EN ISO 15001:2012 | Identical |
| NS EN ISO 15001 : 2011 | Identical |
| NF EN ISO 15001 : 2012 | Identical |
| UNE-EN ISO 15001:2012 | Identical |
| UNI 11341 : 2010 | BUBBLING HUMIDIFIERS FOR MEDICAL USE - FUNDAMENTAL REQUIREMENTS |
| 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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