EN ISO 14937:2000/AC:2005
(Corrigendum)Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)
CMC - Renumber Annex ZC into Annex ZA
Sterilisation von Produkten für die Gesundheitsfürsorge - Allgemeine Anforderungen an die Charakterisierung eines Sterilisiermittels und an die Entwicklung, Validierung und Routineüberwachung eines Sterilisationsverfahrens für Medizinprodukte (ISO 14937:2000)
Stérilisation des produits de santé - Exigences générales pour la caractérisation d'un agent stérilisant et pour le développement, la validation et la vérification de routine d'un processus de stérilisation pour dispositifs médicaux (ISO 14937:2000)
Sterilizacija izdelkov za zdravstveno nego - Splošne zahteve za opredelitev lastnosti sterilizacijskih sredstev in za razvoj, validacijo ter rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke (ISO 14937:2000)
General Information
- Status
- Withdrawn
- Publication Date
- 01-Mar-2005
- Withdrawal Date
- 14-Oct-2009
- Technical Committee
- CEN/TC 204 - Sterilization of medical devices
- Drafting Committee
- CEN/TC 204 - Sterilization of medical devices
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 15-Oct-2009
- Completion Date
- 15-Oct-2009
Relations
- Effective Date
- 08-Jun-2022
- Effective Date
- 22-Dec-2008
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 08-Jun-2022
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 ISO 14937:2000/AC:2005 is a corrigendum published by the European Committee for Standardization (CEN). Its full title is "Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)". This standard covers: CMC - Renumber Annex ZC into Annex ZA
CMC - Renumber Annex ZC into Annex ZA
EN ISO 14937:2000/AC:2005 is classified under the following ICS (International Classification for Standards) categories: 11.080.01 - Sterilization and disinfection in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 14937:2000/AC:2005 has the following relationships with other standards: It is inter standard links to EN ISO 14937:2000/AC:2003, EN ISO 14937:2009, EN ISO 1680:2013, EN ISO 6926:2016, EN ISO 7235:2009, EN ISO 11200:2014, EN ISO 14937:2000. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 14937:2000/AC:2005 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC, 98/79/EC. 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 ISO 14937:2000/AC:2005 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-junij-2005
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR6SORãQH]DKWHYH]DRSUHGHOLWHY
ODVWQRVWLVWHULOL]DFLMVNLKVUHGVWHYLQ]DUD]YRMYDOLGDFLMRWHUUXWLQVNRNRQWUROR
VWHULOL]DFLMVNLKSRVWRSNRY]DPHGLFLQVNHSULSRPRþNH ,62
Sterilization of health care products - General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization
process for medical devices (ISO 14937:2000)
Sterilisation von Produkten für die Gesundheitsfürsorge - Allgemeine Anforderungen an
die Charakterisierung eines Sterilisiermittels und an die Entwicklung, Validierung und
Routineüberwachung eines Sterilisationsverfahrens für Medizinprodukte (ISO
14937:2000)
Stérilisation des produits de santé - Exigences générales pour la caractérisation d'un
agent stérilisant et pour le développement, la validation et la vérification de routine d'un
processus de stérilisation pour dispositifs médicaux (ISO 14937:2000)
Ta slovenski standard je istoveten z: EN ISO 14937:2000/AC:2005
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 14937:2000/AC
NORME EUROPÉENNE
March 2005
Mars 2005
EUROPÄISCHE NORM
März 2005
ICS 11.080.01
English version
Version Française
Deutsche Fassung
Sterilization of health care products - General requirements for
characterization of a sterilizing agent and the development, validation and
routine control of a sterilization process for medical devices (ISO
14937:2000)
Stérilisation des produits de santé - Sterilisation von Produkten für die
Exigences générales pour la caractérisation
...
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...