BS EN ISO 11737-1:2018 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products

BS EN ISO 11737-1:2018

Sterilization of health care products. Microbiological methods. Determination of a population of microorganisms on products

Status : Current, Under review   Published : February 2018



What is this standard about?

A sterile medical device is one that is free of viable microorganisms. This first part in the BS EN ISO 11737 series specifies the requirements that need to be met to determine the total population of viable microorganisms present.

Who is this standard for?

The medical devices sterilization industry

Why should you use this standard?

It 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.

What’s changed since the last update?

The main changes compared to the previous edition are as follows:

  • The term “bioburden spikes” has been introduced as a normal and consistent part of the bioburden, and examples of data have been provided
  • Clarification has been added that package testing is not typically done except when it is an integral part of the product
  • More information has been provided on the most probable number (MPN) technique and its applications
  • Details have been provided on ways to improve limit of detection (LOD) and correct use of the data
  • Some discussion has been deleted of statistical methods for the evaluation of bioburden data where information was not typical or not required
  • A table has been added with criteria for selection of a recovery efficiency approach, the use of the correction factor (CF) has been explained, and the recovery efficiency value of < 50 % mentioned for technique modifications has been eliminated
  • More information has been provided on the application and performance of a bioburden method suitability test
  • A section has been added to detail rules for direct plate counts, estimated counts and counts beyond the ideal range
  • A table has been added to clarify where typical responsibilities reside for the manufacturer or the laboratory
  • The focus on a risk-based approach has been increased, including the purpose for which bioburden data will be used

Standard NumberBS EN ISO 11737-1:2018
TitleSterilization of health care products. Microbiological methods. Determination of a population of microorganisms on products
StatusCurrent, Under review
Publication Date21 February 2018
Normative References(Required to achieve compliance to this standard)ISO 10012, ISO 13485, IEC 17025, ISO 15189
Informative References(Provided for Information)ISO 9001, ISO 13022, ISO 22442-3, ISO 14937, ICH Q5A(R1), ISO 20857, ISO 11135, ISO 7870-2, ISO 7870-4, ISO 11138-2, IEC 90003, ISO 11737-2, ISO 11139, AAMI TIR37, ASTM D4855-97, ISO 17665 (all parts), ISO 11137 (all parts), ISO 14160, ISO 9000:2015
International RelationshipsEN ISO 11737-1:2018,ISO 11737-1:2018
Amended ByCorrigendum, June 2018; Corrigendum, May 2018
DescriptorsQuality management, Medical equipment, Sterilization (hygiene), Packaging, Microbiology, Biological analysis and testing, Microbiological analysis, Medical instruments, Sterile equipment, Count methods (microbiology)
Title in FrenchStérilisation des produits de santé -- Méthodes microbiologiques Partie 1: Détermination d'une population de microorganismes sur des produits
Title in GermanSterilisation von Produkten für die Gesundheitsfürsorge. Mikrobiologische Verfahren Bestimmung der Population von Mikroorganismen auf Produkten
ISBN978 0 539 01414 3
File Size1.534 MB

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