Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.
ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine Anforderungen (ISO 13408-1:2008)

1.1 Der vorliegende Teil von ISO 13408 legt die allgemeinen Anforderungen an Verfahren, Programme und Verfahrensweisen zur Entwicklung, Validierung und Routinekontrolle des Herstellungsverfahrens für aseptisch hergestellte Produkte für die Gesundheitsfürsorge fest und stellt einen Leitfaden dafür zur Verfügung. 1.2 Der vorliegende Teil von ISO 13408 umfasst Anforderungen und einen Leitfaden in Bezug auf das Gesamtthema der aseptischen Herstellung. Besondere Anforderungen und ein Leitfaden für verschiedene spezielle Prozesse und Verfahren in Bezug auf Filtration, Lyophilisierung, Technologien der Reinigung vor Ort (en: cleaning in place, CIP), Sterilisation vor Ort (en: sterilization in place, SIP) und Isolatorsysteme sind in anderen Teilen von ISO 13408 angeführt. ANMERKUNG Der vorliegende Teil von ISO 13408 ersetzt keine nationalen behördlichen Anforderungen, wie z. B. Gute Herstellungspraktiken (GMP) und/oder Anforderungen von Arzneibüchern, die insbesondere nationale oder regionale Zuständigkeiten betreffen.

Traitement aseptique des produits de santé - Partie 1: Exigences générales (ISO 13408-1:2008, y compris Amd 1:2013)

L'ISO 13408-1:2008 spécifie des exigences générales et propose des directives en matière de méthodes, de programmes et de modes opératoires pour le développement, la validation et le contrôle de produits de santé soumis à un traitement aseptique.
L'ISO 13408-1:2008 comprend des exigences et des directives relatives au domaine général du traitement aseptique. Des exigences et des directives spécifiques sur les divers procédés et méthodes spécialisés de filtration, de lyophilisation, de nettoyage in situ, de stérilisation in situ et de systèmes isolateurs sont indiquées dans les différentes parties de l'ISO 13408.

Aseptična proizvodnja izdelkov za zdravstveno nego - 1. del: Splošne zahteve (ISO 13408-1:2008, vključno z Amd 1:2013)

Standard ISO 13408-1:2008 določa splošne zahteve in ponuja smernice za postopke, programe in postopke za razvoj, validacijo in rutinsko kontrolo proizvodnega procesa za aseptično proizvodnjo izdelkov za zdravstveno nego.
Standard ISO 13408-1:2008 zajema zahteve in smernice v povezavi z aseptično proizvodnjo na splošno. Posebne zahteve in smernice glede različnih specializiranih postopkov in metod, povezanih s filtracijo, liofilizacijo, tehnologijami CIP (čiščenje v zaprtih sistemih), sistemi za sterilizacijo (SIP) in izolatorskimi sistemi, so določene v drugih delih standarda ISO 13408.

General Information

Status
Published
Publication Date
09-Jun-2015
Withdrawal Date
30-Dec-2015
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
10-Jun-2015
Completion Date
10-Jun-2015

Relations

Buy Standard

Standard
EN ISO 13408-1:2015
English language
68 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13408-1:2015
01-september-2015
1DGRPHãþD
SIST EN ISO 13408-1:2011
SIST EN ISO 13408-1:2011/A1:2013
$VHSWLþQDSURL]YRGQMDL]GHONRY]D]GUDYVWYHQRQHJRGHO6SORãQH]DKWHYH ,62
YNOMXþQR]$PG
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-
1:2008, including Amd 1:2013)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine
Anforderungen (ISO 13408-1:2008)
Traitement aseptique des produits de santé - Partie 1: Exigences générales (ISO 13408-
1:2008, y compris Amd 1:2013)
Ta slovenski standard je istoveten z: EN ISO 13408-1:2015
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 13408-1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN ISO 13408-1:2015

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

SIST EN ISO 13408-1:2015

EUROPEAN STANDARD
EN ISO 13408-1

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2015
ICS 11.080.01 Supersedes EN ISO 13408-1:2011
English Version
Aseptic processing of health care products - Part 1: General
requirements (ISO 13408-1:2008, including Amd 1:2013)
Traitement aseptique des produits de santé - Partie 1: Aseptische Herstellung von Produkten für die
Exigences générales (ISO 13408-1:2008, y compris Amd Gesundheitsfürsorge - Teil 1: Allgemeine Anforderungen
1:2013) (ISO 13408-1:2008, einschließlich Amd 1:2013)
This European Standard was approved by CEN on 20 May 2015.

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, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13408-1:2015 E
worldwide for CEN national Members.

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

SIST EN ISO 13408-1:2015
EN ISO 13408-1:2015 (E)
Contents Page
Foreword . 2
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable medical devices . 4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices . 5
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices . 6

1

---------------------- Page: 4 ----------------------

SIST EN ISO 13408-1:2015
EN ISO 13408-1:2015 (E)
Foreword
The text of ISO 13408-1:2008, including Amd 1:2013 has been prepared by Technical Committee
ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization
(ISO) and has been taken over as EN ISO 13408-1:2015 by 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 December 2015, and conflicting national standards shall
be withdrawn at the latest by December 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 13408-1:2011.
This document has been p
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.