ISO 11195:2018
Current
The latest, up-to-date edition.
Gas mixers for medical use — Stand-alone gas mixers
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English
25-01-2018
ISO 11195:2018 specifies requirements for the performance and safety of stand-alone gas mixers intended for mixing oxygen with another gas for medical use.
ISO 11195:2018 does not apply to:
a) blocks of flowmeters with separate controls for the flow of each gas;
b) stand-alone gas mixers which mix oxygen with ambient air;
c) stand-alone gas mixers with more than two different gas inlets;
d) stand-alone gas mixers connected to an oxygen concentrator.
| Committee |
ISO/TC 121/SC 1
|
| DevelopmentNote |
Supersedes ISO/DIS 11195. (01/2018)
|
| DocumentType |
Standard
|
| Pages |
19
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| BS ISO 11195:1995 | Identical |
| BS ISO 11195:2018 | Identical |
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| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 15001:2010 | Anaesthetic and respiratory equipment — Compatibility with oxygen |
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| ISO 5359:2014 | Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases |
| ISO 80601-2-55:2011 | Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
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| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 10524-1:2006 | Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices |
| ISO 15223-1:2016 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements |
| EN 13544-2:2002+A1:2009 | Respiratory therapy equipment - Part 2: Tubing and connectors |
| ISO 7396-1:2016 | Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |
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