EN 1174-3:1996
(Main)Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: Guide to the methods for validation of microbiological techniques
Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: Guide to the methods for validation of microbiological techniques
This Part of EN 1174 gives guidance by describing approaches which may be taken when validating techniques for bioburden estimation. This guidance is not intended to be exhaustive but is intended to highlight important aspects of methodology to which attention should be given. This document is informative and does not contain requirements.
Sterilisation von Medizinprodukten - Schätzung der Population von Mikroorganismen auf einem Produkt - Teil 3: Leitfaden zu den Validierungsverfahren für mikrobiologische Methoden
Dieser Teil der EN 1174 beschreibt Verfahrensweisen für die Validierung von Methoden zur Schätzung der Keimbelastung. Dieses Dokument dient der Informationund enthält keine Anforderungen.
Stérilisation des dispositifs médicaux - Estimation de la population de micro-organismes sur un produit - Partie 3: Lignes directrices concernant les méthodes de validation des techniques microbiologiques
Cette partie de la norme EN 1174 décrit les approches pouvant ête suivies lors de la validation des techniques d'estimation de la charge microbienne. Le présent document a été élaboré à titre informatif et ne contient aucune prescription devant être appliquée.
Sterilizacija medicinskih pripomočkov - Ocena populacije mikroorganizmov na izdelku - 3. del: Vodilo za validacijske metode mikrobioloških postopkov
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- Withdrawn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
Get Certified
Connect with accredited certification bodies for this standard
BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.
TÜV Rheinland
TÜV Rheinland is a leading international provider of technical services.
TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.
Sponsored listings
Frequently Asked Questions
EN 1174-3:1996 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 3: Guide to the methods for validation of microbiological techniques". This standard covers: This Part of EN 1174 gives guidance by describing approaches which may be taken when validating techniques for bioburden estimation. This guidance is not intended to be exhaustive but is intended to highlight important aspects of methodology to which attention should be given. This document is informative and does not contain requirements.
This Part of EN 1174 gives guidance by describing approaches which may be taken when validating techniques for bioburden estimation. This guidance is not intended to be exhaustive but is intended to highlight important aspects of methodology to which attention should be given. This document is informative and does not contain requirements.
EN 1174-3:1996 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 1174-3:1996 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 1174-3:1996 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 1174-3:1996 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.VWRSNRYSterilisation von Medizinprodukten - Schätzung der Population von Mikroorganismen auf einem Produkt - Teil 3: Leitfaden zu den Validierungsverfahren für mikrobiologische MethodenStérilisation des dispositifs médicaux - Estimation de la population de micro-organismes sur un produit - Partie 3: Lignes directrices concernant les méthodes de validation des techniques microbiologiquesSterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: Guide to the methods for validation of microbiological techniqu
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...