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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.

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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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