UNE-EN ISO 18472:2020
Current
The latest, up-to-date edition.
Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2018)
Hardcopy , PDF
Spanish, Castilian, English
01-04-2020
This International Standard specifies the requirements for test equipment to be used to:
test biological Indicators for steam, ethylene oxide and dry heat processes for conformity to the
requirements given in ISO 11138;
test chemical indicators for steam, ethylene oxide, dry heat and vaporized hydrogen peroxide
processes for conformity to the requirements given in ISO 11140.
This International Standard also provides informative methods useful in characterizing the
performance of biological and chemical indicators for intended use and for routine quality control
testing.
This International Standard does not specify requirements for test equipment for processes specifically
for testing chemical and biological indicators intended to monitor isolator and room biodecontamination
processes at atmospheric pressure.
ISO 11138-2, ISO 11138-3, ISO 11138-4, and ISO 11140-1 require the use of resistometers specified in
this International Standard, and these resistometers are used in conjunction with the test methods
specified in the appropriate parts of ISO 11138 and ISO 11140.
NOTE Resistometers for low temperature steam and formaldehyde indicators are not included in this
International Standard. Test methods using laboratory apparatus for low temperature steam and
formaldehyde are included in ISO 11138-5.
Test equipment for testing Type 2 (e.g. Bowie Dick) chemical indicators are specified in ISO 11140-3 and
ISO 11140-4.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
45
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 18472:2018 | Identical |
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