prEN 556-1
(Main)Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of 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), designation of a medical device as ‘STERILE’ is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441.
Sterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als "STERIL" gekennzeichnet werden - Teil 1: Anforderungen an Medizinprodukte, die in der Endpackung sterilisiert wurden
Dieses Dokument legt die Anforderungen an ein in der Endpackung sterilisiertes Medizinprodukt fest, das als „STERIL“ gekennzeichnet wird. Teil 2 dieser Europäischen 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“ nur gestattet, wenn ein validiertes Sterilisationsverfahren angewandt wurde. Anforderungen an die Validierung und die Routineüberwachung von Sterilisationsverfahren für Medizinprodukte sind EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665 1, EN ISO 20857, EN ISO 25424 und ISO 22441 angegeben.
Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage « STÉRILE » - Partie 1 : Exigences relatives aux dispositifs médicaux stérilisés de façon terminale
Le présent document spécifie les exigences à satisfaire pour qu’un dispositif médical stérilisé de façon terminale puisse être étiqueté « STÉRILE ». La partie 2 de la présente Norme européenne 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 n’est admise que si un procédé de stérilisation validé a été appliqué. Les exigences de validation et de contrôle de routine des procédés de stérilisation des dispositifs médicaux sont spécifiées dans l’EN ISO 11135, l’EN ISO 11137, l’EN ISO 14160, l’EN ISO 14937, l’EN ISO 17665-1, l’EN ISO 20857, l’EN ISO 25424 et l’ISO 22441.
Sterilizacija medicinskih pripomočkov - Zahteve za medicinske pripomočke, ki morajo biti označeni s "STERILNO" - 1. del: Zahteve za končno sterilizirane medicinske pripomočke
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN 556-1:2023
01-marec-2023
Sterilizacija medicinskih pripomočkov - Zahteve za medicinske pripomočke, ki
morajo biti označeni s "STERILNO" - 1. del: Zahteve za končno sterilizirane
medicinske pripomočke
Sterilization of medical devices - Requirements for medical devices to be designated
"STERILE" - Part 1: Requirements for terminally sterilized medical devicesSterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als
"STERIL" gekennzeichnet werden - Teil 1: Anforderungen an Medizinprodukte, die in der
Endpackung sterilisiert wurdenStérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en
vue d'obtenir l'étiquetage « STÉRILE » - Partie 1 : Exigences relatives aux dispositifs
médicaux stérilisés de façon terminaleTa slovenski standard je istoveten z: prEN 556-1
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN 556-1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 556-1:2023
DRAFT
EUROPEAN STANDARD
prEN 556-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2023
ICS 11.080.01 Will supersede EN 556-1:2001
English Version
Sterilization of medical devices - Requirements for medical
devices to be designated "STERILE" - Part 1: Requirements
for terminally sterilized 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 1 : Exigences relatives werden - Teil 1: Anforderungen an Medizinprodukte,
aux dispositifs médicaux stérilisés de façon terminale die in der Endpackung sterilisiert wurden
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 556-1:2023 E
worldwide for CEN national Members.---------------------- Page: 3 ----------------------
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prEN 556-1:2023 (E)
Contents Page
European foreword ................................................................................................................................................................ 3
Introduction ............................................................................................................................................................................. 4
1 Scope .................................................................................................................................................................................... 5
2 Normative references .................................................................................................................................................... 5
3 Terms and definitions ................................................................................................................................................... 5
4 Requirements ................................................................................................................................................................... 7
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered ..................... 8
Annex ZB (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered ...................11
Bibliography ...........................................................................................................................................................................13
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prEN 556-1:2023 (E)
European foreword
This document (prEN 556-1:2023) 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 556-1:2001 and EN 556-1:2001/AC:2006.
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.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 [this document];
— Part 2: Requirements for aseptically processed medical devices.prEN 556-1:2023 includes the following significant technical changes with respect to EN 556-1:2001 and
EN 556-1:2001/AC:2006:— definitions have been aligned with EN 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 document 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.---------------------- Page: 5 ----------------------
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Introduction
A sterile product item is one, which is free of viable microorganisms. European standards for medical devices
require, when it is necessary to supply a sterile product item, that adventitious microbiological
contamination of a medical device from all sources is minimized by all practical means. Even so, product
items produced under standard manufacturing conditions in accordance with their requirements for quality
systems for medical devices (see EN ISO 13485:2016 and EN ISO 13485:2016/A11:2021) can, prior to
sterilization, have microorganisms on them, albeit in low numbers. Such product items are non-sterile. The
purpose of sterilization processing is to inactivate the microbiological contaminants and thereby transform
the non-sterile items into sterile ones.The inactivation of a pure culture of microorganisms by physical and/or chemical agents used to sterilize
medical devices often approximates to an exponential relationship; inevitably this means that, regardless of
the extent of treatment applied, there is always a finite probability that a microorganism will survive. For a
given treatment, the probability of survival is determined by the number and resistance of microorganisms
and by the environment in which the organisms exist during treatment. It follows that the sterility of any
one item subjected to sterilization processing cannot be guaranteed and the sterility of the processed items
has to be defined in terms of the probability of the existence of a surviving microorganism on/in an item.
The standards for quality management systems recognize that there are processes used which cannot be
fully verified by subsequent inspection and testing of product. Sterilization is an example of such a process.
Sterilization processes have to be validated before use, the performance of the process monitored routinely
and the equipment maintained.It is important to be aware that exposure to a properly validated and accurately controlled sterilization
process is not the only factor associated with the provision of assurance that the product item is sterile and,
in this respect, suitable for its intended use. Attention has also to be given to a number of factors including
the microbiological status (bioburden) of incoming raw materials and/or components, their subsequent
storage and to the control of the environment in which the product is manufactured, assembled and
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1 Scope
This document specifies the requirements for a terminally sterilized medical device to be designated
‘STERILE’. Part 2 of 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), designation of a medical
device as ‘STERILE’ is only permissible when a validated sterilization process has been applied. Requirements for
validation and routine control of processes for the sterilization of medical devices are specified in EN ISO 11135,
EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441.
2 Normative referencesThe 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 13485:2016, Medical devices — Quality management systems — Requirements for regulatory
purposes (ISO 13485:2016)3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at https://www.electropedia.org/— ISO Online browsing platform: available at https://www.iso.org/obp
3.1
bioburden
population of viable microorganisms on or in a product and/or sterile barrier system
[Source: EN ISO 11139:2018, 3.23]3.2
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;
As impacted by EN ISO 13485:2016/A11:2021.
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— 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 meansNote 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;
— 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: EN ISO 13485:2016 and EN ISO 13485:2016/A11:2021, 3.11, modified — The first two list items in
Note 1 to entry have been added.]3.3
sterility
state of being free from viable micro-organisms
[Source: EN ISO 11139:2018, 3.274]
3.4
sterile
condition of a medical device that is free from viable micro-organisms
[Source: EN ISO 11139:2018, 3.271]
3.5
sterility assurance level
SAL
probability of a single viable microorganism occurring on an item after sterilization
Note 1 to entry: It is expressed as the negative exponent to the base 10.[Source: EN ISO 11139:2018, 3.275]
3.6
terminally sterilized
condition of a product that has been exposed to a sterilization process in its sterilized barrier system
[Source EN ISO 11139:2018, 3.296]---------------------- Page: 8 ----------------------
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4 Requirements
4.1 For a terminally sterilized medical device to be designated "STERILE", the probability of there being a
viable micro-organism present on/in the device shall be equal to or less than 1×10 .
NOTE 1 Permission for acceptance of a probability greater than that specified in 4.1 may be sought through the
appropriate regulatory bodies. Such permission requires consideration of the individual situation, including
consideration of the risk management process (see, for example, EN ISO 14971) undertaken by the manufacturer of the
medical device.NOTE 2 ISO/TS 19930 provides guidance on identifying the aspects to be considered as part of a risk-based approach
to selecting a sterility assurance level (SAL) for terminally sterilized, single-use heal
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