This document specifies tests for substances leached by liquid water condensing into GAS PATHWAYS of a MEDICAL DEVICE, its parts or ACCESSORIES, which are intended to provide respiratory care or supply substances via the respiratory tract to a PATIENT in all environments. The tests of this document are intended to quantify hazardous water-soluble substances that are leached from the MEDICAL DEVICE, its parts or ACCESSORIES by condensate and then conveyed by that liquid to the PATIENT. This document establishes acceptance criteria for these tests.

This document addresses potential contamination of the gas stream arising from the GAS PATHWAYS, which is then conducted to the PATIENT.

This document applies over the EXPECTED SERVICE LIFE of the MEDICAL DEVICE in NORMAL USE and takes into account the effects of any intended processing or reprocessing

Cross References:
ISO 7396-1:2016
ISO 10993-5
ISO 18562-1:2017
ISO 14971:2007
ISO 10993-1
ISO 10993-10
ISO 10993-12:2012
ISO 10993-18
TS 10993-19
ISO 10993-11
ISO 10993-9
ISO 10993-17
ISO 10993-15
TS 10993-20
ISO 10993-4
ISO 10993-16
ISO 10993-13
ISO 10993-6
ISO 10993-3
ISO 10993-2
ISO 10993-14
ISO 16142-1:2016
ISO 10993-7


Incorporates the following:
Corrigendum, February 2020