EN ISO 15001:2011
Current
Current
The latest, up-to-date edition.
Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
Published date
10-19-2011
Publisher
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
ISO 15001:2010 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, ISO 15001:2010 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 ISO 15001:2010 include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition at the design, manufacturing, maintenance and disposal stages.ISO 15001:2010 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.
| Committee |
CEN/TC 215
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| UNI EN ISO 15001 : 2012 | Identical |
| I.S. EN ISO 15001:2011 | Identical |
| SN EN ISO 15001:2012 | Identical |
| NS EN ISO 15001 : 2011 | Identical |
| PN EN ISO 15001 : 2011 | Identical |
| NF EN ISO 15001 : 2012 | Identical |
| UNE-EN ISO 15001:2012 | Identical |
| 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 |
| 04/30084857 DC : DRAFT JUN 2004 | BS EN ISO 10524-1 - PRESSURE REGULATORS FOR USE WITH MEDICAL GAS SYSTEMS - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
| DIN EN 14931 E : 2006 | PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBER SYSTEMS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING |
| UNE-EN 15908:2011 | Anaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases |
| 05/30128373 DC : DRAFT JAN 2005 | ISO 7396-2 - MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS - BASIC REQUIREMENTS |
| BS EN 14931:2006 | Pressure vessels for human occupancy (PVHO). Multi-place pressure chambers for hyperbaric therapy. Performance, safety requirements and testing |
| I.S. EN 14931:2006 | PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBER SYSTEMS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING |
| DIN EN 14931:2006-08 | Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing |
| DIN EN 15908:2011-01 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
| EN 13544-1:2007+A1:2009 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
| BS EN 15333-1:2008 | Respiratory equipment. Open-circuit umbilical supplied compressed gas diving apparatus Demand apparatus |
| BS EN 15908:2010 | Anaesthetic and respiratory equipment. Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases |
| 07/30169528 DC : 0 | BS EN 15333-2 - RESPIRATORY EQUIPMENT - OPEN-CIRCUIT UMBILICAL SUPPLIED COMPRESSED GAS DIVING APPARATUS - PART 2: FREE FLOW APPARATUS |
| DIN EN 15333-2:2009-07 | RESPIRATORY EQUIPMENT - OPEN-CIRCUIT UMBILICAL SUPPLIED COMPRESSED GAS DIVING APPARATUS - PART 2: FREE FLOW APPARATUS |
| UNI EN 15333-2 : 2009 | RESPIRATORY EQUIPMENT - OPEN-CIRCUIT UMBILICAL SUPPLIED COMPRESSED GAS DIVING APPARATUS - PART 2: FREE FLOW APPARATUS |
| UNI EN 15333-1 : 2008 | RESPIRATORY EQUIPMENT - OPEN-CIRCUIT UMBILICAL SUPPLIED COMPRESSED GAS DIVING APPARATUS - PART 1: DEMAND APPARATUS |
| I.S. EN 15333-1:2008 | RESPIRATORY EQUIPMENT - OPEN-CIRCUIT UMBILICAL SUPPLIED COMPRESSED GAS DIVING APPARATUS - PART 1: DEMAND APPARATUS |
| DIN EN 13544-1:2009-12 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| I.S. EN 13544-1:2007 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| UNI EN 13544-1 : 2009 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| UNI EN 15908 : 2010 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
| EN ISO 5359:2014/A1:2017 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014/AMD 1:2017) |
| BS EN 15333-2:2009 | Respiratory equipment. Open-circuit umbilical supplied compressed gas diving apparatus Free flow apparatus |
| I.S. EN 15333-2:2009 | RESPIRATORY EQUIPMENT - OPEN-CIRCUIT UMBILICAL SUPPLIED COMPRESSED GAS DIVING APPARATUS - PART 2: FREE FLOW APPARATUS |
| I.S. EN 15908:2010 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
| BS EN 13544-1 : 2007 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| EN 15908:2010 | Anaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases |
| EN 15333-2:2009 | Respiratory equipment - Open-circuit umbilical supplied compressed gas diving apparatus - Part 2: Free flow apparatus |
| EN 14931:2006 | Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing |
| BS EN ISO 5359 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES |
| 06/30116855 DC : 0 | BS ISO 10524-4 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS INTENDED FOR INCORPORATION INTO MEDICAL EQUIPMENT |
| 04/30088537 DC : DRAFT SEP 2004 | PREN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM |
| DIN EN 15333-1:2008-04 | RESPIRATORY EQUIPMENT - OPEN-CIRCUIT UMBILICAL SUPPLIED COMPRESSED GAS DIVING APPARATUS - PART 1: DEMAND APPARATUS |
| DIN EN 15908 E : 2011 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
| 07/30147572 DC : DRAFT SEP 2007 | BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| EN 15333-1 : 2008/AC : 2009 | RESPIRATORY EQUIPMENT - OPEN-CIRCUIT UMBILICAL SUPPLIED COMPRESSED GAS DIVING APPARATUS - PART 1: DEMAND APPARATUS |
| UNE-EN 13544-1:2007 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
| 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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