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Guideline on oxygen tank calibration

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Guest user Created:   Feb 02, 2021 Last commented:   Feb 03, 2021

Guideline on oxygen tank calibration

Need your help to tell me is there a guideline on the oxygen tank?calibration?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Feb 03, 2021

This depends on which market you are in.

On the US market, all necessary information you can find in the document

7356-002E Compressed Medical Gases – FDA. This is the Compliance program guidance manual issued March 15, 2015, talking about Compressed medical gases (CMG or medical gases) include gaseous and liquid (cryogenic) forms stored in high-pressure cylinders that are administered as a gas. Another important document is Current Good Manufacturing Practice for Medical Gases – FDA, issued June 2017. On the EU market, the main source of information is European Industrial Gases Association, https://eiga.eu/

The most important element of the tanks is pressure regulators. Technical aspects are covered in the following standards:

  • ISO 10524-1:2018 Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices
  • ISO 10524-2:2018 Pressure regulators for use with medical gases — Part 2: Manifold and line pressure regulators
  • ISO 10524-3:2019 Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves (VIPRs)
  • ISO 10524-4:2008 Pressure regulators for use with medical gases — Part 4: Low-pressure regulators

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Feb 02, 2021

Feb 03, 2021

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