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UNE-EN ISO 18472:2020

Current

Current

The latest, up-to-date edition.

Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2018)

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

01-04-2020

€110.40
Excluding VAT

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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€110.40
Excluding VAT