iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

EN ISO 13408-1:2024

(Main)

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

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

General Information

Status
Published
Publication Date
23-Apr-2024
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
24-Apr-2024
Completion Date
24-Apr-2024
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
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
SIST EN ISO 13408-1:2024 - Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

Relations

Replaces
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

Buy Standard

EN ISO 13408-1:2024EN ISO 13408-1:2024
PreviousNext
Standard
EN ISO 13408-1:2024
English language
91 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day
prEN ISO 13408-1:2022 - BARVEprEN ISO 13408-1:2022 - BARVE
PreviousNext
Draft
prEN ISO 13408-1:2022 - BARVE
English language
83 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13408-1:2024
01-julij-2024
Aseptična proizvodnja izdelkov za zdravstveno nego - 1. del: Splošne zahteve (ISO
13408-1:2023)
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-
1:2023)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine
Anforderungen (ISO 13408-1:2023)
Traitement aseptique des produits de santé - Partie 1 : Exigences générales (ISO 13408
-1:2023)
Ta slovenski standard je istoveten z: EN ISO 13408-1:2024
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 13408-1:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 13408-1:2024

---------------------- Page: 2 ----------------------
SIST EN ISO 13408-1:2024


EN ISO 13408-1
EUROPEAN STANDARD

NORME EUROPÉENNE

April 2024
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN ISO 13408-1:2015
English Version

Aseptic processing of health care products - Part 1:
General requirements (ISO 13408-1:2023)
Traitement aseptique des produits de santé - Partie 1: Aseptische Herstellung von Produkten für die
Exigences générales (ISO 13408-1:2023) Gesundheitsfürsorge - Teil 1: Allgemeine
Anforderungen (ISO 13408-1:2023)
This European Standard was approved by CEN on 2 July 2023.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13408-1:2024 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST EN ISO 13408-1:2024
EN ISO 13408-1:2024 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance requirements of Regulation (EU) 2017/745 aimed to be
covered. 4
Annex ZB (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 8

2

---------------------- Page: 4 ----------------------
SIST EN ISO 13408-1:2024
EN ISO 13408-1:2024 (E)
European foreword
This document (EN ISO 13408-1:2024) 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 October 2024, and conflicting national standards shall
be withdrawn at the latest by October 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 13408-1:2015.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see in
...

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.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 13408-1:2022

---------------------- Page: 2 ----------------------
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.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 13408-1:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2021

---------------------- Page: 3 ----------------------
oSIST prEN ISO 13408-1:2022
ISO/DIS 13408-1:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
  © ISO 2021 – All rights reserved

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

Questions, Comments and Discussion

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

This May Also Interest You

CEN
EN ISO 17665:2024(Main)
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
SIST EN ISO 17665:2024

This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.

  • Standard
    172 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    158 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 17664-2:2023(Main)
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)
SIST EN ISO 17664-2:2024

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact).
This includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:
a)   preparation before processing;
b)   cleaning;
c)   disinfection;
d)   drying;
e)   inspection and maintenance;
f)    packaging;
g)   storage;
h)   transportation.
This document excludes processing of:
1)   critical and semi-critical medical devices;
2)   medical devices intended to be sterilized;
3)   textile medical devices used in patient draping systems or surgical clothing;
4)   medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE     See Annex E for further guidance on the application of the ISO 17664 series to a medical device.

  • Standard
    34 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 13004:2023(Main)
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
SIST EN ISO 13004:2023

Adoption of ISO 13004:2022 – This is currently in FDIS and will be publishing in October 2022.
This document describes a method for substantiating a selected sterilization dose of 17,5,
20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less for radiation
sterilization of health care products. This Technical Specification also specifies a method of sterilization
dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.
NOTE Selection and substantiation of the sterilization dose is used to meet the requirements for establishing
the sterilization dose within process definition in ISO 11137-1.

  • Standard
    63 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    60 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN ISO/TS 11137-4:2023(Main)
Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)
SIST-TS CEN ISO/TS 11137-4:2023

This document provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.

  • Technical specification
    64 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    61 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 11137-2:2015/A1:2023(Amendment)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
SIST EN ISO 11137-2:2015/A1:2023

2022-06-21 - lack of compliance - publication on hold

  • Amendment
    13 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 25424:2019/A1:2022(Amendment)
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
SIST EN ISO 25424:2020/A1:2022

2022-01-13 - TC decision is missing to skip FV - publication on hold.

  • Amendment
    15 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 17664-1:2021(Main)
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
SIST EN ISO 17664-1:2021

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.
This includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:
a) initial treatment at the point of use;
b) preparation before cleaning;
c) cleaning;
d) disinfection;
e) drying;
f) inspection and maintenance;
g) packaging;
h) sterilization;
i) storage;
j) transportation.
This document excludes processing of the following:
—    non-critical medical devices unless they are intended to be sterilized;
—    textile devices used in patient draping systems or surgical clothing;
—    medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE       See ISO 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a medical device.

  • Standard
    34 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 14160:2021(Main)
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020)
SIST EN ISO 14160:2021

This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin.
This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see NOTE 1).
This document is not applicable to material of human origin.
This document does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see NOTE 2 and NOTE 3).
This document does not describe methods for validation of the inactivation or elimination of protozoa and parasites.
The requirements for validation and routine control described in this document are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps (see NOTE 4).
This document does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device (see NOTE 5).
This document does not cover the level of residual sterilizing agent within medical devices (see NOTE 6).
Guidance for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin is provided in informative Annex A.
NOTE 1  The prior application of risk management principles to medical devices utilizing animal tissues, as described in ISO 22442-1 is important. ISO 18362 provides information on control of microbial risks during processing of cell-based health-care products.
NOTE 2  Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this document does not necessarily demonstrate inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal materials are described in ISO 22442-2.
NOTE 3  The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE agents is described in ISO 22442-3.
NOTE 4  Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the manufacturing process, a medical device is exposed to a specified sterilization process.
NOTE 5  Such testing is a crucial part of the design and development of a medical device.
NOTE 6  ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents.
NOTE 7  Standards for quality management systems (see ISO 13485) can be used in the control of all stages of manufacture including the sterilization process.

  • Standard
    50 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 11737-1:2018/A1:2021(Amendment)
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
SIST EN ISO 11737-1:2018/A1:2021
  • Amendment
    13 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 13408-6:2021(Main)
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
SIST EN ISO 13408-6:2021

This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products.
This document does not specify requirements for restricted access barrier systems (RABS).
This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions.
This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.
This document does not define biosafety containment requirements.

  • Standard
    39 pages
    English language
    sale 10% off
    e-Library read for
    1 day