EN 867-1:1997
(Main)Non-biological systems for use in sterilizers - Part 1: General requirements
Non-biological systems for use in sterilizers - Part 1: General requirements
This part of EN 867 specifies general requirements for indicators which are not dependent for their action on the presence or absence of living organismes, and which are used to monitor the presence or attainment of one or more of the variables required for a satisfactory sterilisation process. This standard does not specify requirements for the use of biological systems.
Nichtbiologische Systeme für den Gebrauch in Sterilisatoren - Teil 1: Allgemeine Anforderungen
Dieser Teil von EN 867 legt allgemeine Anforderungen an Indikatoren fest, die in ihrer Wirkung nicht von der Anwesenheit oder Abwesenheit von lebenden Organismus abhängig sind und die zur Überwachung des Vorhandenseins oder der Erreichung einer oder mehrerer der für einen zufriedenstellenden Sterilisationsprozess erforderlichen Kennwerte verwendet wird. Diese Norm legt keine Anforderungen für die Verwendung biologischer Systeme fest.
Systèmes non-biologiques destinés à être utilisés dans des stérilisateurs - Partie 1: Exigences générales
La présente partie de la norme EN 867 spécifie les exigences générales pour des indicateurs qui ne dépendent pas, pour leur action, de la présence ou de l'absence d'organismes vivants et qui sont utilisés pour surveiller la présence ou l'obtention d'une ou plusieurs des varibles exigées pour un procédé de stérilisation satisfaisant. La présente norme ne spécifie pas les exigences pour l'utilisation de systèmes biologiques.
Nebiološki sistemi za uporabo v sterilizatorjih - 1. del: Splošne zahteve
General Information
- Status
- Withdrawn
- Publication Date
- 18-Feb-1997
- Withdrawal Date
- 14-Jul-2005
- Technical Committee
- CEN/TC 102 - Sterilizers for medical purposes
- Drafting Committee
- CEN/TC 102/WG 7 - Biological and chemical indicators
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 15-Jul-2005
- Completion Date
- 15-Jul-2005
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 28-Jan-2026
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 867-1:1997 is a standard published by the European Committee for Standardization (CEN). Its full title is "Non-biological systems for use in sterilizers - Part 1: General requirements". This standard covers: This part of EN 867 specifies general requirements for indicators which are not dependent for their action on the presence or absence of living organismes, and which are used to monitor the presence or attainment of one or more of the variables required for a satisfactory sterilisation process. This standard does not specify requirements for the use of biological systems.
This part of EN 867 specifies general requirements for indicators which are not dependent for their action on the presence or absence of living organismes, and which are used to monitor the presence or attainment of one or more of the variables required for a satisfactory sterilisation process. This standard does not specify requirements for the use of biological systems.
EN 867-1:1997 is classified under the following ICS (International Classification for Standards) categories: 11.080 - Sterilization and disinfection. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 867-1:1997 has the following relationships with other standards: It is inter standard links to EN ISO 11140-1:2005, EN 13060:2004+A2:2010. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 867-1:1997 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. 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 867-1:1997 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)
SLOVENSKI STANDARD
01-januar-2000
Nebiološki sistemi za uporabo v sterilizatorjih - 1. del: Splošne zahteve
Non-biological systems for use in sterilizers - Part 1: General requirements
Nichtbiologische Systeme für den Gebrauch in Sterilisatoren - Teil 1: Allgemeine
Anforderungen
Systemes non-biologiques destinés a etre utilisés dans des stérilisateurs - Partie 1:
Exigences générales
Ta slovenski standard je istoveten z: EN 867-1:1997
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
...
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...