oSIST prEN 556-2:2023

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices

This document specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.
NOTE   For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408-1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408-7.

Sterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als ''STERIL'' gekennzeichnet werden - Teil 2: Anforderungen an aseptisch hergestellte Medizinprodukte

Dieses Dokument legt die Anforderungen an ein aseptisch hergestelltes Medizinprodukt fest, das als „STERIL“ gekennzeichnet wird.
ANMERKUNG   Für die Anwendung der EU-Richtlinie(n) für Medizinprodukte (siehe Literaturhinweise) ist die Kennzeichnung eines Medizinproduktes als „STERIL“ gestattet, wenn ein validiertes Sterilisationsverfahren angewandt wurde. Anforderungen an die Validierung und die Routineüberwachung von aseptischen Verfahren sind in EN ISO 13408 1 festgelegt. Spezielle Anforderungen an aseptischen Verfahren bei festen Medizinprodukten und Kombinations-Medizinprodukten sind in ISO 13408 7 festgelegt.

Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage « STÉRILE » - Partie 2 : Exigences relatives aux dispositifs médicaux soumis à un traitement aseptique

Le présent document spécifie les exigences à satisfaire pour qu’un dispositif médical soumis à un traitement aseptique puisse être étiqueté « STÉRILE ».
NOTE   Pour les besoins de la ou des Directives UE concernant les dispositifs médicaux (voir Bibliographie), l’apposition d’une étiquette « STÉRILE » sur un dispositif médical est admise lorsqu’un procédé de fabrication et de stérilisation validé a été appliqué. Les exigences relatives à la validation et au contrôle de routine des procédés aseptiques sont spécifiées dans l’EN ISO 13408-1. Les exigences spécifiques relatives au traitement aseptique de dispositifs médicaux solides et aux produits de combinaison sont spécifiées dans l’ISO 13408-7.

Sterilizacija medicinskih pripomočkov - Zahteve za medicinske pripomočke, ki morajo biti označeni s "STERILNO" - 2. del: Zahteve za medicinske pripomočke, izdelane v aseptičnem okolju

General Information

• Status: Not Published
• Public Enquiry End Date: 30-Mar-2023
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 25-Jan-2023
• Due Date: 14-Jun-2023
• Completion Date: 06-Apr-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: FprEN 556-2 - Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: requirements for aseptically processed medical devices

Relations

• Revises: SIST EN 556-2:2015 - Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN 556-2:2023
01-marec-2023
Sterilizacija medicinskih pripomočkov - Zahteve za medicinske pripomočke, ki
morajo biti označeni s "STERILNO" - 2. del: Zahteve za medicinske pripomočke,
izdelane v aseptičnem okolju
Sterilization of medical devices - Requirements for medical devices to be designated
''STERILE" - Part 2: Requirements for aseptically processed medical devices
Sterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als
''STERIL'' gekennzeichnet werden - Teil 2: Anforderungen an aseptisch hergestellte
Medizinprodukte
Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en
vue d'obtenir l'étiquetage « STÉRILE » - Partie 2 : Exigences relatives aux dispositifs
médicaux soumis à un traitement aseptique
Ta slovenski standard je istoveten z: prEN 556-2
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN 556-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 556-2:2023

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oSIST prEN 556-2:2023


DRAFT
EUROPEAN STANDARD
prEN 556-2
NORME EUROPÉENNE

EUROPÄISCHE NORM

January 2023
ICS 11.080.01 Will supersede EN 556-2:2015
English Version

Sterilization of medical devices - Requirements for medical
devices to be designated ''STERILE" - Part 2: requirements
for aseptically processed medical devices
Stérilisation des dispositifs médicaux - Exigences Sterilisation von Medizinprodukten - Anforderungen
relatives aux dispositifs médicaux en vue d'obtenir an Medizinprodukte, die als ''STERIL'' gekennzeichnet
l'étiquetage " STÉRILE " - Partie 2 : Exigences relatives werden - Teil 2: Anforderungen an aseptisch
aux dispositifs médicaux soumis à un traitement hergestellte Medizinprodukte
aseptique
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 204.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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.

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.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 556-2:2023 E
worldwide for CEN national Members.

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oSIST prEN 556-2:2023
prEN 556-2:2023 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 6
4 Requirements . 8
4.1 Validation and routine control .
...