INTERNATIONAL ISO

STANDARD 11737-1

Third edition
2018-01
AMENDMENT 1
2021-05

Sterilization of health care products —

Microbiological methods —
Part 1:
Determination of a population of
microorganisms on products
AMENDMENT 1
Stérilisation des produits de santé — Méthodes microbiologiques —
Partie 1: Détermination d'une population de microorganismes sur des
produits
AMENDEMENT 1

Reference number
ISO 11737-1:2018/Amd.1:2021(E)

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Foreword
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This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www​.iso​.org/​members​.html.


© ISO 2021 – All rights reservedEste documento ha sido adquirido por STEELDEC, S.A. el 2023-8-24. iii
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 Este documento ha sido adquirido por STEELDEC, S.A. el 2023-8-24.
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 ISO 11737-1:2018/Amd.1:2021(E)

Sterilization of health care products — Microbiological

methods —
Part 1:
Determination of a population of microorganisms on
products
AMENDMENT 1

Clause 4
Replace with the following:
4   General
4.1   The development, validation and routine control of a sterilization process is a critical element
in product realization of health care product. To ensure the consistent implementation of the
requirements specified in this document, the necessary processes need to be established, implemented
and maintained. Processes of particular importance in relation to the development, validation and
routine control of a sterilization process include but are not limited to:
— control of documentation, including records,
— assignment of management responsibility,
— provision of adequate resources, including competent human resources and infrastructure,
— control of product provided by external parties,
— identification and traceability of product throughout the process, and
— control of non-conforming product.
NOTE ISO 13485 covers all stages of the lifecycle of medical devices in the context of quality management
systems for regulatory purposes. National and/or regional regulatory requirements for the provision of health
care product can require the implementation of a full quality management system and the assessment of that
system by a recognized conformity assessment body.

4.2   A process shall be specified for the calibration of all equipment, including instrumentation for test
purposes, used in meeting the requirements of this document.

B.3.3.4
Replace with the following:
B.3.3.4   MPN methods are simple to perform, and the statistical basis for the method makes it
more appropriate for general assessment rather than accurate determinations. The MPN method for
10 samples of a single dilution is shown in Table 5 of the FDA BAM[27]. This single dilution method
does not incorporate additional dilutions that could provide further information about the number of
microorganisms producing a positive sample. Alternatively, Formula (B.1) can be used for individual


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samples or SIPs to determine a most probable number. Formula (B.1) is a simplified version of the
original formula from Cochran[42].
n 1
MPN ( sd or SIP ) = ln   (B.1)
 s  SIP
where

sd is for single dilution;

ln represents natural log;

n is the total number of samples tested;

s is the number of samples negative for growth.

Bibliography
Add the following:
Cochran W. Estimation of Bacterial Densities by Means of the Most Probable Number, Biometrics. 6:105-
116, 1950

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ISO 11737-1:2018/Amd.1:2021(E)


ICS 11.080.01; 07.100.10

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