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Standard Organization:

Recognized Consensus Standards

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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Recognition List034
Recognition Number1-78
Extent Complete standard
Standards Orgs ASME American Society of Mechanical Engineers https://www.asme.org/
STG Anesthesiology
FDA Tech  Nam To   FDA/OMPT/CDRH/ODE/DAGID/ANDB/   301-796-4634   Ka.To@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This Standard applies to all pressure vessels that enclose a human within its pressure boundary while under internal or external pressure exceeding a differential pressure of 2 psi. PVHOs include, but are not limited to, submersibles, diving bells, personnel transfer capsules; and decompression, recompression, hypobaric, and hyperbaric PVHOs.

Code of Federal Regulations:

Recognized Consensus Standards
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U.S. Department of Health and Human Services

Recognized Consensus Standards
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FDA Guidance:

Recognized Consensus Standards

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U.S. Department of Health and Human Services

Recognized Consensus Standards
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