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BS EN ISO 18472:2018

Current

Current

The latest, up-to-date edition.

Sterilization of health care products. Biological and chemical indicators. Test equipment

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

19-09-2018

€271.12
Excluding VAT

This document specifies the requirements for test equipment to be used to:— test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the requirements given in ISO 11138 series; — test chemical indicators for steam, ethylene oxide gas, dry heat and vaporized hydrogen peroxide sterilization processes for conformity to the requirements given in ISO 11140-1:2014.

Committee
CH/198
DocumentType
Standard
ISBN
9780580917301
Pages
38
ProductNote
This Standard Also Referes to IEC 60584:2013
PublisherName
British Standards Institution
Status
Current
Supersedes

This document specifies the requirements for test equipment to be used to:

  • test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the requirements given in ISO11138series ;

  • test chemical indicators for steam, ethylene oxide gas, dry heat and vaporized hydrogen peroxide sterilization processes for conformity to the requirements given in ISO11140‑1:2014 .

This document also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing.

This document 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.

ISO11138‑2:2017 , ISO11138‑3:2017 , ISO11138‑4:2017 and ISO11140‑1:2014 require the use of resistometers specified in this document, and these resistometers are used in conjunction with the test methods specified in the appropriate parts of ISO11138series and ISO11140series .

Resistometers for low temperature steam and formaldehyde indicators are not included in this document. Test methods using laboratory apparatus for low temperature steam and formaldehyde are included in ISO11138‑5:2017 .

Test equipment for testing Type 2 (e.g. Bowie Dick) chemical indicators are specified in ISO11140‑3:2007 , ISO11140‑4:2007 , and ISO11140‑5:2007 .

Standards Relationship
EN ISO 18472:2018 Identical
EN ISO 18472:2006 Identical
ISO 18472:2018 Identical

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