Gas mixers for medical use - Stand-alone gas mixers
1Key Takeaways
This document specifies requirements for the performance and safety of stand-alone gas mixers intended for mixing oxygen with another gas for medical use. This document does not apply to: a) blocks of flowmeters with separate controls for the flow of each gas; c) stand-alone gas mixers with more than two different gas …
2Expert Interpretation
This comprehensive analysis of the ISO 11195:2018 standard for the performance requirements and safety specifications of standalone medical gas mixers covers key technical indicators such as material compatibility, alarm systems, and gas precision control. It is suitable for anesthesia and respiratory equipment manufacturers and quality management personnel in medical institutions.
Analysis of the core content of the standard
| Technical Dimensions | 1995 Edition | Main Changes in the 2018 Edition |
|---|---|---|
| Scope of Application | General Gas Mixing Device | Explicitly Excludes Oxygen Concentrator Connection Equipment |
| Material Requirements | Basic Compatibility Test | Newly Added Non-metallic Components Auto-ignition Temperature ≥160℃ Requirement |
| Alarm System | Basic Sound and Light Alarm | Distinguishing between attended/unattended Chapter 4 of the standard specifies three basic performance requirements for independent gas mixers:
Material compatibility requirementsClause 6.5 stipulates that metal parts in contact with oxygen are prohibited from electroplating, and non-metallic materials must pass the ISO 11114-3 auto-ignition test. In actual application, please note: A certain brand of mixer caused a fire accident in a hyperbaric oxygen environment due to the use of silicone-containing lubricant. Implementation recommendations
3Version History
ISO 11195:2018
2018-01-01
5Citation Network3
Cite this standard
21
Referenced herein
Standards that cite ISO 11195:2018
Lung ventilators — Part 4: Particular requirements for user-powered resuscitators
Lung ventilators - Particular requirements for user-powered resuscitators
Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO/DIS 10651-4:2021); German and English version prEN ISO 10651-4:2021 / Note: Date of issue 2021-07-09*Intended as replacement for DIN EN ISO 10651-4 (2009-08).
Referenced by ISO 11195:2018
EN 13544-2:2002
EN 15986:2011
IEC 60601-1 Edition 3.1:2012
IEC 60601-1-6 Edition 3.1:2013
IEC 60601-1-8 AMD 1:2012
IEC 60601-1-8:2006
IEC 62366-1:2015
ISO 10524-1:2006
6Frequently Asked QuestionsWhat is ISO 11195:2018?
ISO 11195:2018 — Gas mixers for medical use - Stand-alone gas mixers is an international standard developed by International Organization for Standardization (ISO). This document specifies requirements for the performance and safety of stand-alone gas mixers intended for mixing oxygen with another gas for medical use. This document does not apply to: a) blocks of flowmeters with separate controls for the flow...
What does ISO 11195:2018 cover?
This standard covers: This document specifies requirements for the performance and safety of stand-alone gas mixers intended for mixing oxygen with another gas for medical use. This document does not apply to: a) blocks of flowmeters with separate controls for the flow of each gas; c) stand-alone gas mixers with more...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
What is the latest version of ISO 11195:2018?
The current published version is ISO 11195:2018, published on 2018-01-01. Always check for amendments or pending revisions.
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