EN ISO 11737-1:2018

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)

Publication date:   Apr 16, 2018

General information

60.60 Standard published   Jan 31, 2018

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

07.100.10   Medical microbiology | 11.080.01   Sterilization and disinfection in general

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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.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

93/42/EEC

Medical devices

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Harmonized/Supporting
2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 11737-1:2006

WITHDRAWN
EN ISO 11737-1:2006/AC:2009

NOW

PUBLISHED
EN ISO 11737-1:2018
60.60 Standard published
Jan 31, 2018

CORRIGENDA / AMENDMENTS

PUBLISHED
EN ISO 11737-1:2018/A1:2021

REVISED BY

IN_DEVELOPMENT
prEN ISO 11737-1 rev