This is a test for establishing the capability of the sterilisation process to remove air and effect steam penetration into a PCD containing a lumen.  The challenge device is not meant to represent any particular medical device but will present a challenge to air removal and steam penetration analogous to medical devices having lumens.

ISO 17665:2024 – Annex C.2

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This is a test for steam penetration into a medical device(s) that containing lumens. The test is based on a hollow load test piece described in BS EN 285, A1. This test complements the tests in which the standard test pack is specified during validation.

The result of the hollow load test is judged from exposure to a chemical indicator inserted into the test piece.

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