ISO 11737-1:2018

Status : Published (Under review)

This standard was last reviewed and confirmed in 2023. Therefore this version remains current.

	Format	Language
std 1 166	PDF + ePub
std 2 166	Paper

CHF166

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Abstract

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.

General information

Status
: Published

Publication date
: 2018-01

Stage
: International Standard confirmed [90.93]
Edition
: 3

Number of pages
: 48
Technical Committee :
ISO/TC 198

ICS :
07.100.10 11.080.01
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