CEN/TC 204/WG 5 - Bioburden of medical devices

ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.

This Part of this European Standard provides guidance on the implementation of the requirements specified in EN 1174-1. It is aimed at providing a better understanding of EN 1174-1 as well as assisting in implementing its requirements. The guidance given is not intended to be exhaustive, but to highlight important aspects to which attention should be given.  NOTE: This Part of EN 1174-1 is informative and does not contain requirements.  This Part of this European Standard is not intended as a checklist for assessing compliance with EN 1174-1.

This Part of EN 1174 gives guidance by describing approaches which may be taken when validating techniques for bioburden estimation.  This guidance is not intended to be exhaustive but is intended to highlight important aspects of methodology to which attention should be given.  This document is informative and does not contain requirements.

1.1 This Part of prEN 1174 specifies general criteria to be applied in the estimation of the population of viable micro-organisms on a medical device or on a component, raw material or package. This estimation consists of both enumeration and characterization of the population.  Note 1: Prior to routine use, a technique for estimating the population of micro-organisms on product is validated. The level to which, during characterization, identification is necessary is dependent on the use to be made of the data generated.   Note 2: Parts 2 and 3 of this European Standard will provide guidance on selection of a technique and outline method(s) which may be used to validate the technique selected.   Note 3: A bibliography of useful standards is given in Annex A.   1.2 This Part of EN 1174 is not applicable to the enumeration or identification of viral contamination.  1.3 This Part of EN 1174 is not applicable to the microbiological monitoring of the environment in which medical devices are manufactured (see Note1).   Note 1: Standards on environmental monitoring are being prepared by CEN/TC 243.   Note 2:  Attention is drawn to the standards for quality systems (see EN 46001 or EN 46002) which control all stages of manufacture including the sterilization process. It is not a requirement of this standard to have a complete quality system during manufacture but certain elements of such a system are required and these are normatively referenced at appropriate places in the text.