EN 867-2:1997
(Main)Non-biological systems for use in sterilizers - Part 2: Process indicators (Class A)
Non-biological systems for use in sterilizers - Part 2: Process indicators (Class A)
This part of EN 867 specifies requirements for steam, ethylene oxide, irradiation, dry heat and steam/formaldehyde sterilisation process indicators intended for use with individual packs of product to demonstrate that the pack has been exposed to the process. They may be designed to react to one or more of the critical process variables but may be designed to achieve their end-point reaction after exposure to sub-optimal levels of the process variable. Process indicators have a defined end-point reaction.
Nichtbiologische Systeme für den Gebrauch in Sterilisatoren - Teil 2: Prozeßindikatoren (Klasse A)
Dieser Teil von EN 867 legt Anforderungen an Prozessindikatoren für die Sterilisation mit Dampf, Ethylenoxid, Bestrahlung, trockener Wärme und Dampf/Formaldehyd fest, die für einzelne Packungen des Produktes vorgesehen sind, um nachzuweisen, dass die Verpackung diesem Verfahren ausgesetzt wurde. Sie können auf eine oder mehrere der kritischen Prozessvoariablen reagieren, können jedoch auch ihre Endpunktreaktion nach Einwirkung von Pegeln unterhalb der optimalen Pegel der Prozessvariablen erreichen. Prozessindikatoren haben eine definierte Endpunktreaktion.
Systèmes non-biologiques destinés à être utilisés dans des stérilisateurs - Partie 2: Indicateurs de procédé (Class A)
La présente partie de la norme EN 867 spécifie les exigences pour les indicateurs pour la stérilisation à la vapeur d'eau, à l'oxyde d'éthylène, par rayonnement, à la chaleur sèche et à la vapeur d'eau/au formaldéhyde. Ces indicateurs sont prévus pour être utilisés avec des paquets isolés de produit, afin de montrer que le dit paquet a été exposé au procédé. Ils peuvent être conçus pour réagir à une ou plusieurs des variables critiques de procédé, mais peuvent être conçus pour réaliser leur réaction de point limita après exposition à des niveaux sous-optimaux de la variable de procédé.
Nebiološki sistemi za uporabo v sterilizatorjih - 2. del: Indikatorji postopkov (razred A)
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- Withdrawn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
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 867-2:1997 is a standard published by the European Committee for Standardization (CEN). Its full title is "Non-biological systems for use in sterilizers - Part 2: Process indicators (Class A)". This standard covers: This part of EN 867 specifies requirements for steam, ethylene oxide, irradiation, dry heat and steam/formaldehyde sterilisation process indicators intended for use with individual packs of product to demonstrate that the pack has been exposed to the process. They may be designed to react to one or more of the critical process variables but may be designed to achieve their end-point reaction after exposure to sub-optimal levels of the process variable. Process indicators have a defined end-point reaction.
This part of EN 867 specifies requirements for steam, ethylene oxide, irradiation, dry heat and steam/formaldehyde sterilisation process indicators intended for use with individual packs of product to demonstrate that the pack has been exposed to the process. They may be designed to react to one or more of the critical process variables but may be designed to achieve their end-point reaction after exposure to sub-optimal levels of the process variable. Process indicators have a defined end-point reaction.
EN 867-2:1997 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 867-2:1997 has the following relationships with other standards: It is inter standard links to EN ISO 11140-1:2005. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 867-2:1997 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 867-2:1997 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 - 2. del: Indikatorji postopkov
(razred A)
Non-biological systems for use in sterilizers - Part 2: Process indicators (Class A)
Nichtbiologische Systeme für den Gebrauch in Sterilisatoren - Teil 2: Prozeßindikatoren
(Klasse A)
Systemes non-biologiques destinés a etre utilisés dans des stérilisateurs - Partie 2:
Indicateurs de procédé (Class A)
Ta slovenski standard je istoveten z: EN 867-2:1997
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...