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 EN ISO 13408-7 (in preparation).

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 EN ISO 13408-7 (in Vorbereitung) 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 européennes relatives aux dispositifs médicaux (voir la bibliographie), l’apposition d’une étiquette «STÉRILE» sur un dispositif médical est admise lorsqu’un procédé de fabrication et de stérilisation validé a été utilisé. Les exigences de validation et de contrôle de routine des traitements aseptiques sont spécifiées dans l’EN ISO 13408-1. Les exigences propres au traitement aseptique des dispositifs médicaux solides et des produits de combinaison sont spécifiées dans l’EN ISO 13408-7 (en cours d’élaboration).

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
Public Enquiry End Date
14-Apr-2014
Publication Date
18-Oct-2015
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
10-Sep-2015
Due Date
15-Nov-2015
Completion Date
19-Oct-2015

RELATIONS

Buy Standard

Standard
SIST EN 556-2:2015
English language
16 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

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.

---------------------- Page: 1 ----------------------
SIST EN 556-2:2015
---------------------- Page: 2 ----------------------
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.
---------------------- Page: 3 ----------------------
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 .............................................................................................................................. 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

---------------------- Page: 4 ----------------------
SIST EN 556-2:2015
EN 556-2:2015 (E)
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.
---------------------- Page: 5 ----------------------
SIST EN 556-2:2015
EN 556-2:2015 (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.

---------------------- Page: 6 ----------------------
SIST EN 556-2:2015
EN 556-2:2015 (E)
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)
---------------------- Page: 7 ----------------------
SIST EN 556-2:2015
EN 556-2:2015 (E)
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

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]
---------------------- Page: 8 ----------------------
SIST EN 556-2:2015
EN 556-2:2015 (E)
3.5
process simulation

exercise that simulates the manufacturing process or portions of the process in order to demonstrate the

capability of the aseptic process to prevent biological contamination
[SOURCE: ISO 13408-7:2012, 3.2]

Note 1 to entry: Other terms for process simulation include media fill, simulated process fill, simulated filling

operation, broth trial, broth fill.
3.6
requalification

repetition of part of validation for the purpose of confirming the continued acceptability of a specified

process
[SOURCE: ISO/TS 11139:2006, 2.40]
3.7
sterility
state of being free from viable micro-organisms
[SOURCE: ISO/TS 11139:2006, 2.45]
3.8
sterile
free from viable microorganisms
[SOURCE: ISO/TS 11139:2006, 2.43]
3.9
terminally-sterilized

condition of a medical device which has been exposed to a sterilization process in a packaged or

assembled form that maintains the sterility of the medical device or a defined portion thereof

[SOURCE: EN 556-1:2001, 3.5]
3.10
test for sterility

technical operation defined in an official Pharmacopoeia performed on product following exposure to a

sterilization process
[SOURCE: ISO/TS 11139:2006, 2.53]

Note 1 to entry: For the purpose of this document, the official Pharmacopoeia that applies is the European

Pharmacopoeia.
3.11
validation

documented procedure for obtaining, recording and interpreting the results required to establish that a

process will consistently yield product complying with predetermined specifications

[SOURCE: ISO/TS 11139:2006, 2.55]
---------------------- Page: 9 ----------------------
SIST EN 556-2:2015
EN 556-2:2015 (E)
4 Requirements
4.1 Validation and routine control
For an aseptically processed medical device, the following shall apply:

a) the manufacturing environment in which the aseptic process is conducted is specified and records

demonstrating compliance with the specification throughout the conduct of the process are prepared

and maintained;

b) the processes employed to sterilize product, components, equipment and packaging are validated

and rou
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.