SIST EN 1174-1:2000
(Main)Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements
Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: 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.
Sterilisation von Medizinprodukten - Schätzung der Population von Mikroorganismen auf einem Produkt - Teil 1: Anforderungen
Dieser Teil von prEN 1174 legt allgemeine Kriterien fest, die bei der Schätzung der Population an lebensfähigen Mikroorganismen an einem Medizinpordukt oder einem Hilfsstoff, einem Rohstoff oder der Verpackung anzuwenden sind. Diese Schätzung besteht sowohl aus der Quantifizierung als auch aus der Charakterisierung der Population.
Stérilisation des dispositifs médicaux - Estimation de la population de micro-organismes sur un produit - Partie 1: Exigences
La présente partie de la norme européenne prEN 1174 spécifie les criteres généraux devant etre appliqués pour estimer la population de micro-organismes viables sur un dispositif médical ou un composant, une matiere premiere ou un emballage. Cette estimation concerne a la fois le dénombrement et la caractérisation de la population.
Sterilizacija medicinskih pripomočkov - Ocena populacije mikroorganizmov na izdelku - 1. del: Zahteve
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilisation von Medizinprodukten - Schätzung der Population von Mikroorganismen auf einem Produkt - Teil 1: AnforderungenStérilisation des dispositifs médicaux - Estimation de la population de micro-organismes sur un produit - Partie 1: ExigencesSterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.