EN 556-2:2015

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

This European Standard 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

Diese Europäische Norm 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 pour les dispositifs médicaux soumis à un traitement aseptique

La présente Norme européenne fixe les exigences à respecter pour qu’un dispositif médical ayant été soumis à un traitement aseptique puisse être étiqueté « STÉRILE ».
NOTE   Dans le cadre de la ou des Directives UE relatives aux dispositifs médicaux (voir la bibliographie), l’apposition d’une étiquette « STÉRILE » sur un dispositif médical est admise lorsqu’un traitement de fabrication et de stérilisation validé a été utilisé. Les exigences de validation et de contrôle de routine des procédés aseptiques sont spécifiées dans l’EN ISO 13408 1. Les exigences propres au traitement aseptique des dispositifs médicaux solides et des produits combinés 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

Ta evropski standard določa zahteve za medicinske pripomočke, izdelane v aseptičnem okolju, z oznako »STERILNO«.
OPOMBA: Za namen tega standarda se uporabljajo direktive Evropske unije za medicinske pripomočke (glej razdelek Literatura), ki določajo, da je uporaba oznake »STERILNO« za medicinski pripomoček dovoljena samo na podlagi potrjenega postopka izdelave in sterilizacije. Zahteve za potrditev in rutinsko kontrolo aseptične proizvodnje so določene v standardu EN ISO 13408-1. Posebne zahteve za aseptično proizvodnjo trdnih medicinskih pripomočkov in kombiniranih proizvodov so določene v standardu EN ISO 13408-7 (v pripravi).

General Information

• Status: Published
• Publication Date: 01-Sep-2015
• Withdrawal Date: 30-Mar-2016
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204/WG 6 - Microbiological quality of processed medical devices
• Current Stage: 9092 - Decision on results of review/2YR ENQ - revise - Review Enquiry
• Completion Date: 27-May-2022
• 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
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 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/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to 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 556-2:2015 - Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices

Relations

• Replaces: EN 556-2:2003 - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
• Effective Date: 09-Sep-2015
• Revised: FprEN 556-2 - 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
SIST EN 556-2:2015
01-november-2015
1DGRPHãþD
SIST EN 556-2:2004
6WHULOL]DFLMDPHGLFLQVNLKSULSRPRþNRY=DKWHYH]DPHGLFLQVNHSULSRPRþNHNL
PRUDMRELWLR]QDþHQLV67(5,/12GHO=DKWHYH]DPHGLFLQVNHSULSRPRþNH
L]GHODQHYDVHSWLþQHPRNROMX
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 pour les dispositifs médicaux
soumis à un traitement aseptique
Ta slovenski standard je istoveten z: EN 556-2:2015
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN 556-2:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 556-2:2015

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SIST EN 556-2:2015


EN 556-2
EUROPEAN STANDARD

NORME EUROPÉENNE

September 2015
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN 556-2:2003
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 pour les werden - Teil 2: Anforderungen an aseptisch
dispositifs médicaux soumis à un traitement aseptique hergestellte Medizinprodukte
This European Standard was approved by CEN on 24 July 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 556-2:2015 E
worldwide for CEN national Members.

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SIST EN 556-2:2015
EN 556-2:2015 (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 . 8
4.2 Compliance . 10
4.3 Documentation and records
...