Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
The text of this standard is sold by ASTM and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| United States | Recognized | F1980-21 | - | Recognition number 14-575. Voluntary: a declaration of conformity to a recognized standard can be used in a submission.. A later notice lists a transition period extension for this entry. |
| Canada | Recognized | Latest version (the list gives no edition or year) | - | When a new version is published, both the newest and the previous version stay recognized for 3 years from the date the newest version was published.. Voluntary: a manufacturer meets the standard, meets an equivalent or better standard, or gives other evidence of safety or effectiveness. A Declaration of Conformity is submitted when a recognized standard is used. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: GB/T 19633.1-2024, ISO 11607-1, ISO 11607-2, ASTM F88, ASTM F1929, ASTM F2096, ASTM D4169. See all standards.
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