ISO 25424-2022 pdf free download – Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices.
Page 2,Clause 3 Terms and definitions
Delete all cross-references within the definitions to other terms defined in Clause 3.
3.18
Replace the sentence after the list (“and does not achieve its primary intended action bypharmacological, immunological or metabolic means, but which may be assisted in its intendedfunction by such means”) with the following:
“and does not achieve its primary intended action by pharmacological, immunological or metabolicmeans, in or on the human body, but which may be assisted in its intended function by such means”.
Correct sOURCE statement
from:
[SOURCE: IS0 13485:2016,3.11, modified – The first two list items in Note 1 to entry have beenadded.]
to:
[SOURCE:1S0 13485:2016,3.11, modified —The first two list items in Note 1 to entry have beenadded and the paragraph after the firstlist has been modified to include “in or on the human body”.]3.41
Replace term and definition with the correct definition from IS0 11139:2018,3.137 as follows:
3.41
inactivation curve
graphical representation of decrease in viability of a population of microorganisms with increasingexposure to a microbicidal agent under stated conditions
11.1 b) and c)
Replace 11.1 b) and c) with the following text:
b)if chemical indicators are used as part of the product release, the complete colour change of these
[see 8.4 and 10.3);
c) if biological indicators or PCDs containing BIs are used as part of the product release, acceptable results after cultivation of these (see 8.3 and 10.2); and
Table D.1
Replace wrong cross-reference in line “3 emission to air”/column “Use, Stage C”, second to last line from C.9.3.4 to C.9.4.4.ISO 25424 pdf download.