EN 1174-2:1996
(Main)Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance
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- Withdrawn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
- 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
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN 1174-2:1996 is a standard published by the European Committee for Standardization (CEN). Its full title is "Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance". This standard covers: 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 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.
EN 1174-2:1996 is classified under the following ICS (International Classification for Standards) categories: 07.100.10 - Medical microbiology; 11.080 - Sterilization and disinfection. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 1174-2:1996 has the following relationships with other standards: It is inter standard links to EN ISO 11737-1:2006. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1174-2:1996 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC; Standardization Mandates: M/BC/CEN/89/9. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 1174-2:1996 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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
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