EN 1174-2:1996

Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance

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.

Sterilisation von Medizinprodukten - Schätzung der Population von Mikroorganismen auf einem Produkt - Teil 2: Leitfaden

Dieser Teil der vorliegenden Europäischen Norm stellt einen Leitfaden für die Umsetzung der EN 1174-1 dar. Er soll zum besseren Verständnis der EN 1174-1 dienen und dabei zugleich eine Hand-reichung zur Umsetzung ihrer Anforderungen darstellen. Der Leitfaden soll nicht erschöpfend sein, sondern die Aufmerksamkeit auf wichtige aspekte lenken.

Stérilisation des dispositifs médicaux - Estimation de la population de micro-organismes sur un produit - Partie 2: Lignes directrices

La présente partie de la norme européenne constitue un guide pour la mise en oeuvre de la norme EN 1174-1. Son objectif est d'en permettre une meilleure compréhension tout en facilitant l'application de ses exigences. Elle ne prétendpas être exhaustive mais elle souligne certains aspects importants qui devraient faire l'objet d'une attention particulière.

Sterilizacija medicinskih pripomočkov - Ocena populacije mikroorganizmov na izdelku - 2. del: Navodilo

General Information

• Status: Withdrawn
• Publication Date: 19-Nov-1996
• Withdrawal Date: 31-Mar-2006
• ICS: 07.100.10 - Medical microbiology
• ICS: 11.080 - Sterilization and disinfection
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204/WG 5 - Bioburden of medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Apr-2006
• Completion Date: 01-Apr-2006
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN 1174-2:2000 - Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance

Relations

• Replaced By: EN ISO 11737-1:2006 - Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
• Effective Date: 22-Dec-2008

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 2: LeitfadenStérilisation des dispositifs médicaux - Estimation de la population de micro-organismes sur un produit - Partie 2: Lignes directricesSterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in general07.100.10Medicinska mikrobiologijaMedical microbiologyICS:Ta slovenski standard je istoveten z:EN 1174-2:1996SIST EN 1174-2:2000en01-januar-2000SIST EN 11
...