scope:

This part of ISO 11737 specifies general criteria to be applied in the estimation of the population of viable microorganisms on a medical device or component, raw material or package thereof. This estimation consists of both enumeration and characterization of the population.

NOTES

1 Prior to routine use, a technique for estimating the population of microorganisms on product is validated. The level to which identification is necessary during characterization depends on the use to be made of the data generated.

2 Annexes to this part of ISO 11737 provide guidance on selection of a technique and outline method(s) which may be used to validate the technique selected.

This part of ISO 11737 is not applicable to the enumeration or identification of viral contamination. This part of ISO 11737 is not applicable to the micro-biological monitoring of the environment in which medical devices are manufactured.

NOTE 3 Attention is drawn to the International Standards for quality systems (see ISO 9001 and ISO 9002) which control all stages of manufacture including the sterilization process. It is not a requirement of this part of ISO 11737 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.