FprEN ISO 13408-1

Aseptic processing of health care products - Part 1: General requirements (ISO/FDIS 13408-1:2023)

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

Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine Anforderungen (ISO/FDIS 13408-1:2023)

Dieses Dokument legt die allgemeinen Anforderungen an Verfahren, Programme und Verfahrensweisen zur Entwicklung, Validierung und routinemäßigen Kontrolle der aseptischen Herstellung von Produkten für die Gesundheitsfürsorge fest und stellt einen Leitfaden dafür zur Verfügung.
Dieses Dokument 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 Sterilfiltration, Lyophilisierung, Technologien der Reinigung vor Ort (en: cleaning in place, CIP), Sterilisation vor Ort (en: sterilization in place, SIP) und Isolatorensysteme sind in den anderen Teilen der Normenreihe ISO 13408 angeführt.

Traitement aseptique des produits de santé - Partie 1 : Exigences générales (ISO/FDIS 13408-1:2023)

Le présent document spécifie des exigences générales et propose des recommandations en matière de procédés, de programmes et de modes opératoires pour le développement, la validation et le contrôle de routine du traitement aseptique des produits de santé.
Le présent document spécifie comprend des exigences et des recommandations relatives à la thématique générale du traitement aseptique.
Des exigences et des recommandations spécifiques relatives aux divers procédés et méthodes spécialisés de filtration stérilisante, de lyophilisation, de nettoyage in situ (CIP), de stérilisation in situ (SIP) et de systèmes isolateurs sont indiquées dans les autres parties de la série ISO 13408.

Aseptična proizvodnja izdelkov za zdravstveno nego - 1. del: Splošne zahteve (ISO/FDIS 13408-1:2023)

General Information

• Status: Not Published
• Publication Date: 03-Sep-2023
• 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: 6055 - CEN Ratification completed (DOR) - Publishing
• Start Date: 02-Jul-2023
• Completion Date: 02-Jul-2023
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: kSIST FprEN ISO 13408-1:2023 - Aseptic processing of health care products - Part 1: General requirements (ISO/FDIS 13408-1:2023)

Relations

• Revises: EN ISO 13408-1:2015 - Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 13408-1:2022
01-februar-2022
Aseptična proizvodnja izdelkov za zdravstveno nego - 1. del: Splošne zahteve
(ISO/DIS 13408-1:2021)
Aseptic processing of health care products - Part 1: General requirements (ISO/DIS
13408-1:2021)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine
Anforderungen (ISO/DIS 13408-1:2021)
Traitement aseptique des produits de santé - Partie 1 : Exigences générales (ISO/DIS
13408-1:2021)
Ta slovenski standard je istoveten z: prEN ISO 13408-1
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN ISO 13408-1:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 13408-1:2022

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oSIST prEN ISO 13408-1:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 13408-1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-12-16 2022-03-10
Aseptic processing of health care products —
Part 1:
General requirements
Traitement aseptique des produits de santé —
Partie 1: Exigences générales
ICS: 11.080.01
This document is circulated as received from the committee secretariat.
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oSIST prEN ISO 13408-1:2022
ISO/DIS 13408-1:2021(E)
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oSIST prEN ISO 13408-1:2022
ISO/DIS 13408-1:2021(E)
Contents Page
Foreword . vi
Introduction .viii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 8
5 Principles of aseptic processing .8
5.1 General . 8
5.2 Use of an aseptic process . 9
5.3 Core elements .
...