EN 556-2:2015

SLOVENSKI STANDARD
01-november-2015
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SIST EN 556-2:2004
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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 . 10
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable medical devices . 11
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices. 12
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices . 13
Bibliography . 15

European foreword
This document (EN 556-2:2015) has been prepared by 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 March 2016, and conflicting national standards shall be
withdrawn at the latest by March 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN 556-2:2003.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annexes ZA, ZB and ZC, 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].
The following amendments have been made in updating the document from EN 556-2:2003:
a) normative references have been updated;
b) terms and definitions have been aligned with ISO/TS 11139 and EN ISO 13408-1;
c) requirements on validation and routine control have been revised;
d) Table 1 and Table 2 on acceptance limits and actions for occurrence of non-sterile units in process
simulations in initial performance qualification and in periodic requalification, respectively, have
been added;
e) editorial revision according to the CEN Internal Regulations.
Annexes designated ‘informative’ are given only for information. In this standard Annexes ZA, ZB and ZC
are informative.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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 the
United Kingdom.
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.
1 Scope
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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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)
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)
EN ISO 13408-2:2011, Aseptic processing of health care products — Part 2: Filtration (ISO 13408-2:2003)
EN ISO 13408-5:2011, Aseptic processing of health care products — Part 5: Sterilization in place
(ISO 13408-5:2006)
EN ISO 13485:2012, Medical devices — Quality management systems — Requirements for regulatory
purposes (ISO 13485:2003)
EN ISO 14160:2011, 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 14160:2011)
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)
EN ISO 25424:2011, Sterilization of medical devices — Low temperature steam and formaldehyde —
Requirements for development, validation and routine control of a sterilization process for medical devices
(ISO 25424:2009)
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: ISO/TS 11139:2006, 2.2]
3.3
medical device
instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, 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 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 for medical purposes by means of in vitro examination of specimens derived
from the human body
and which does not achieve its primary intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
[SOURCE: EN ISO 13485:2012, 3.7]
3.4
performance qualification
PQ
process of obtaining and documenting evidence that the equipment, as installed and operated in
accordance with operational procedures, consistently performs in accordance with predetermined
criteria and thereby yields product meeting its specification
[SOURCE: ISO/TS 11139:2006, 2.30]
3.5
process simulation
exercise that simulates the manufacturing process or portions of the process in order to demonstrate the
capability of
...