EN 1174-1:1996

Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements

Publication date:   Nov 20, 2003

Scope

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.

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