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STANDARD 11139
First edition
2018-08
AMENDMENT 1
Sterilization of health care products —
Vocabulary of terms used in
sterilization and related equipment
and process standards
AMENDMENT 1: Amended and additional
terms and definitions
Stérilisation des produits de santé — Vocabulaire des termes utilisés
dans les normes de procédés de stérilisation et les équipements
connexes
AMENDEMENT 1: Termes et définitions modifiés et supplémentaires
PROOF/ÉPREUVE
Reference number
ISO 11139:2018/Amd.1:2023(E)
© ISO 2023
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ISO 11139:2018/Amd.1:2023(E)
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PROOF/ÉPREUVE © ISO 2023 – All rights reserved
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ISO 11139:2018/Amd.1:2023(E)
Foreword
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This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products,
in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/
TC 102, Sterilizers for medical purposes, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
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© ISO 2023 – All rights reserved PROOF/ÉPREUVE
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ISO 11139:2018/Amd.1:2023(E)
Sterilization of health care products — Vocabulary of terms
used in sterilization and related equipment and process
standards
AMENDMENT 1: Amended and additional terms and definitions
3.111 exposure phase
Replace the term and the text of the definition with the following:
3.111
exposure stage
cycle stage between the introduction of the sterilizing agent or disinfecting agent into the chamber and
when its microbicidal effect has become negligible
Note 1 to entry: The exposure stage comprises that part of the process for which microbial lethality is claimed.
3.113.2 F value
BIO
Replace the text of the definition with the following:
3.113.2
F value
BIO
expression of the resistance of a biological indicator calculated as the product of the logarithm to base
10 of the initial population of microorganis
...