Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO/DIS 11737-1:2026)

Comment end date 2026-05-12

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Project stage codes

1. Prioritetinių darbo temų pažymėjimas ir ekspertų skyrimas

2. Projektas

3. Viešoji apklausa

From 2026-03-13 till 2026-05-12

4. Closure of enquiry

5. Submission to Formal Vote

Organisation

CEN Europos standartizacijos komitetas

ICS

07.100.10 - Medical microbiology

Technical Committee

TK 32 Health

ForeignTC'S

CEN/TC 204

Number of comments

Comment start date

2026-03-13

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.

Relations

Pakeis

LST EN ISO 11737-1:2018

Pakeis

prEN ISO 11737-1