SIST EN 556-2:2025

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: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 14-Nov-2024
• Due Date: 19-Jan-2025
• 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: EN 556-2:2024 - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

Relations

• Replaces: 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: 01-Jan-2025

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.

oSIST prEN 556-2:2023
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.

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 . 8
4.2 Compliance .11
4.3 Documentation and records .11
Annex ZA (informative) Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .12
Annex ZB (informative) Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/746 aimed to be covered .15
Bibliography .17
oSIST prEN 556-2:2023
prEN 556-2:2023 (E)
European foreword
This document (prEN 556-2:2023) has been prepared by Technical Committee CEN/TC 204 “Sterilization
of medical devices”, the secretariat of which is held by BSI.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 556-2:2015.
This document has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s) / Regulation(s).
For relationship with EU Directive(s) / Regulation(s), see informative Annexes ZA and ZB, which is an
integral part of this document.
For relationship with EU Directive(s), see informative Annexes ZA and ZB, which are integral parts of this
document.
EN 556, Sterilization of medical devices — Requirements for medical devices to be designated ''STERILE", is
currently composed with the following parts:
— Part 1: Requirements for terminally sterilized medical devices;
— Part 2: Requirements for aseptically processed medical devices [this document].
EN 556-2:2023 includes the following significant technical changes with respect to EN 556-2:2015:
— definitions have been aligned with ISO 11139;
— the normative reference has been updated to the latest edition;
— informative Annex ZA has been replaced with Informative Annexes ZA and ZB giving the relationship
with the European Regulations for medical devices and in vitro diagnostic medical devices
respectively;
— the Bibliography has been updated.
For any use of this standard within the meaning of Annex ZA or ZB, the user should always check that any
referenced document has not been superseded and that its relevant contents can still be considered the
generally acknowledged state-of-art.

oSIST prEN 556-2:2023
prEN 556-2:2023 (E)
Introduction
Medical devices designated 'STERILE' are prepared using appropriate and validated methods. Whenever
possible, sterile medical devices are terminally-sterilized using a properly validated and controlled
sterilization process (see EN 556-1, EN ISO 11135, EN ISO 11137-1, EN ISO 14160, EN ISO 14937,
EN ISO 17665-1, EN ISO 20857 and EN ISO 25424). When a medical device is intended to be sterile but
cannot be terminally sterilized, aseptic processing is the method of manufacture (see EN ISO 13408-1).
Aseptic processing necessitates that either:
a) the entire product is sterilized and then introduced into a sterilized package; or
b) components of the product are sterilized, then further processed/assembled, and the final product
packed into a sterilized package.
Processing/assembly and packaging are carried out in a manner that minimizes the opportunity for items
to become re-contaminated by carrying out these operations in a controlled environment in which
microbial and particulate levels are maintained at or below defined limits and human intervention is
minimized.
NOTE EN ISO 15223-1 specifies the label applied to aseptically processed medical devices as “STERILE A”.

oSIST prEN 556-2:2023
prEN 556-2:2023 (E)
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN ISO 11135:2014, Sterilization of health-care products — Ethylene oxide — Requirements for the
development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014
incorporating amendment 1:2018)
EN ISO 11137-1:2015, Sterilization of health care products — Radiation — Part 1: Requirements for
development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006,
including Amd 1:2013 and Amd 2:2015)
EN ISO 13408-2:2018, Aseptic processing of health care products — Part 2: Sterilizing filtration (ISO 13408-
2:2018)
EN ISO 13408-5:2011, Aseptic processing of health care products — Part 5: Sterilization in place (ISO 13408-
5:2006)
EN ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory
purposes (ISO 13485:2016)
EN ISO 14160:2021, 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)
EN ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices (ISO 14937:2009)
EN ISO 17665-1:2006, Sterilization of health care products — Moist heat — Part 1: Requirements for the
development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
EN ISO 20857:2013, Sterilization of health care products — Dry heat — Requirements for the development,
validation and routine control of a sterilization process for medical devices (ISO 20857:2010)

As impacted by EN ISO 11135:2014/A1:2019.
As impacted by EN ISO 11137-1:2015/A2:2019.
As impacted by EN ISO 13485:2016/AC:2018 and EN ISO 13485:2016/A11:2021.
oSIST prEN 556-2:2023
prEN 556-2:2023 (E)
EN ISO 25424:2019, Sterilization of medical devices — Low temperature steam and formaldehyde —
Requirements for development, validation and routine control of a sterilization process for medical devices
(ISO 25424:2018)
ISO 22441:2022, Sterilization of health care products — Low temperature vaporized hydrogen peroxide —
Requirements for the development, validation and routine control of a sterilization process for medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
aseptic processing
handling of sterile product, containers and/or devices in a controlled environment, in which the air supply,
materials, equipment and personnel are regulated to maintain sterility
[SOURCE: EN ISO 13408-1:2015, 3.4]
3.2
bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[SOURCE: EN ISO 11139:2018, 3.23]
3.3
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, or software
material, or other similar or related article, intended by the manufacturer to be used, alone or in
combination, for human beings, for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment, or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of, or compensation for an injury;
— investigation, replacement, modification, or support of the anatomy, or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological, or metabolic means,
but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions, but not in others
include:
— items specifically intended for cleaning or sterilization of medical devices;

As impacted by EN ISO 25424:2019/A1:2022.
oSIST prEN 556-2:2023
prEN 556-2:2023 (E)
— pouches, reel goods, sterilization wrap, and reusable containers for packaging of medical devices for
sterilization;
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO 13485:2016, 3.11, modified
...