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ISO 11737-1:2018

Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
12 jan 2018

General information

90.92     2 jan 2024

ISO

ISO/TC 198

International Standard

11.080.01     07.100.10  

anglisht   frëngjisht  

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Scope

ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.
NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.
NOTE 2 See Annex A for guidance on Clauses 1 to 9.
ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022.
ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11737-1:2006

WITHDRAWN
ISO 11737-1:2006/Cor 1:2007

NOW

PUBLISHED
ISO 11737-1:2018
90.92 Standard to be revised
2 jan 2024

CORRIGENDA / AMENDMENTS

PUBLISHED
ISO 11737-1:2018/Amd 1:2021

REVISED BY

IN_DEVELOPMENT
ISO/CD 11737-1

National adoptions

Sterilizimi i pajisjeve mjekësore - Metodat mikrobiologjike - Pjesa 1: Përcaktimi i popullimit të mikroorganizmeve në produktet (ISO 11737-1:2018)

60.60 Standard published

DPS/KT 316 më tepër