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EN ISO 13408-2:2018

(Main)

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408‑1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process.
ISO 13408-2:2018 is not applicable to removal of viruses.
Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines).
ISO 13408-2:2018 is not applicable to high efficiency particulate air (HEPA) filters.
ISO 13408-2:2018 does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 2: Sterilfiltration (ISO 13408-2:2018)

Dieses Dokument legt die Anforderung an die in Übereinstimmung mit ISO 13408 1 durchgeführte Sterilfiltration als Teil der aseptischen Herstellung von Produkten für die Gesundheits¬fürsorge fest. Es stellt auch einen Leitfaden für die Filteranwender hinsichtlich der allgemeinen Anforderungen an Einrichtung, Validierung und routinemäßigen Betrieb eines Prozesses der Sterilfiltration zur Verfügung.
Dieses Dokument gilt nicht für das Entfernen von Viren.
Sterilfiltration ist nicht bei Fluiden anwendbar, die absichtlich Partikel enthalten, deren Größe die Porengröße des Filters überschreitet (z. B. bakterielle Ganzzellimpfstoffe).
Dieses Dokument gilt nicht für Schwebstofffilter (en: High Efficiency Particulate Air; HEPA).
Dieses Dokument legt keine Anforderungen für die Entwicklung, Validierung und Lenkung der Anwendung eines Prozesses zur Entfernung der Erreger spongiformer Encephalopathien wie Scrapie, boviner spongiformer Encephalopathie und Creutzfeldt Jakob Krankheit fest. In bestimmten Ländern wurden spezifische Empfehlungen für die Verarbeitung von Materialien entwickelt, die möglicherweise mit diesen Erregern kontaminiert sind.

Traitement aseptique des produits de santé - Partie 2: Filtration stérilisante (ISO 13408-2:2018)

ISO 13408-2:2018 spécifie les exigences de filtration stérilisante dans le cadre du traitement aseptique des produits de santé, mené conformément à ISO 13408‑1. Il propose également aux utilisateurs de filtres des recommandations concernant les exigences générales pour la configuration, la validation et les opérations de routine d'un processus de filtration stérilisante.
ISO 13408-2:2018 ne concerne pas l'élimination des virus.
La filtration stérilisante ne s'applique pas aux fluides contenant volontairement des particules de taille supérieure à la dimension des pores du filtre (par exemple: vaccins à cellules bactériennes entières).
ISO 13408-2:2018 ne s'applique pas aux filtres HEPA (High Efficiency Particulate Air).
ISO 13408-2:2018 ne spécifie pas d'exigences relatives à l'élaboration, à la validation et au contrôle de routine d'un processus d'élimination des agents de prolifération de l'encéphalopathie spongiforme, telle que la tremblante du mouton, l'encéphalopathie spongiforme bovine et la maladie de Creutzfeldt-Jakob. Des recommandations spécifiques ont été rédigées dans des pays déterminés pour le traitement des matériaux potentiellement contaminés par ces agents.

Aseptična proizvodnja izdelkov za zdravstveno nego - 2. del: Sterilizacija s filtracijo (ISO 13408-2:2018)

Ta dokument določa zahteve za sterilizacijo s filtracijo v okviru aseptične proizvodnje izdelkov za zdravstveno nego, izvedene v skladu s standardom ISO 13408-1. Zagotavlja tudi smernice za uporabnike filtrov v zvezi s splošnimi zahtevami za pripravo, potrjevanje in redno izvajanje postopka sterilizacije s filtracijo.
Ta dokument se ne uporablja za odstranjevanje virusov.
Sterilizacija s filtracijo se ne uporablja za tekočine, ki namenoma vsebujejo delce, večje od velikosti por filtra (npr. bakterijska cepiva s celimi celicami).
Ta dokument se ne uporablja za visoko učinkovite zračne filtre drobnih delcev (HEPA).
Ta dokument ne določa zahtev za razvoj, validacijo in rutinsko kontrolo postopka za odstranjevanje povzročiteljev spongiformne encefalopatije, kot so praskavec, bovina spongiformna encefalopatija in Creutzfeldt-Jakobova bolezen. V posameznih državah so bila izdelana posebna priporočila za obdelavo materialov, potencialno okuženih s temi povzročitelji.

General Information

Status
Published
Publication Date
20-Mar-2018
Withdrawal Date
29-Sep-2018
ICS
11.080.01 - Sterilization and disinfection in general
Technical Committee
CEN/TC 204 - Sterilization of medical devices
Drafting Committee
CEN/TC 204 - Sterilization of medical devices
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
21-Mar-2018
Completion Date
21-Mar-2018
Directive
90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Mandate
M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
Ref Project
SIST EN ISO 13408-2:2018 - Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

Relations

Replaces
EN ISO 13408-2:2011 - Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
Effective Date
13-May-2014

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13408-2:2018
01-julij-2018
1DGRPHãþD
SIST EN ISO 13408-2:2011
$VHSWLþQDSURL]YRGQMDL]GHONRY]D]GUDYVWYHQRQHJRGHO6WHULOL]DFLMDV
ILOWUDFLMR ,62
Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-
2:2018)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 2: Sterilfiltration
(ISO 13408-2:2018)
Traitement aseptique des produits de santé - Partie 2: Filtration stérilisante (ISO 13408-
2:2018)
Ta slovenski standard je istoveten z: EN ISO 13408-2:2018
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 13408-2:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 13408-2:2018

---------------------- Page: 2 ----------------------

SIST EN ISO 13408-2:2018


EN ISO 13408-2
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2018
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN ISO 13408-2:2011
English Version

Aseptic processing of health care products - Part 2:
Sterilizing filtration (ISO 13408-2:2018)
Traitement aseptique des produits de santé - Partie 2: Aseptische Herstellung von Produkten für die
Filtration stérilisante (ISO 13408-2:2018) Gesundheitsfürsorge - Teil 2: Sterilfiltration (ISO
13408-2:2018)
This European Standard was approved by CEN on 2 January 2018.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13408-2:2018 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 13408-2:2018
EN ISO 13408-2:2018 (E)
Contents Page
European foreword . 3
Endorsement notice . 4
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable medical devices
[OJ L 189] aimed to be covered . 5
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices [OJ L 169] aimed to be
covered. 6
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices [OJ L
331] aimed to be covered . 7

2

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SIST EN ISO 13408-2:2018
EN ISO 13408-2:2018 (E)
European foreword
This document (EN ISO 13408-2:2018) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 204
“Sterilization of medical devices” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2018, and conflicting national standards
shall be withdrawn at t
...

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