Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, including Amd 1:2014)

ISO 11607-2:2006 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.
ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des Zusammenstellens (ISO 11607-2:2006, einschließlich Amd 1:2014)

Dieser Teil von ISO 11607 legt die Anforderungen für die Entwicklung und Validierung von Verpackungs-prozessen für Medizinprodukte fest, die in der Endverpackung sterilisiert werden. Zu diesen Verfahren gehören die Formgebung, Siegelung und das Zusammenstellen von vorgefertigten Sterilbarrieresystemen, Sterilbarrieresystemen und Verpackungssystemen.
Dieser Teil von ISO 11607 gilt für die Industrie, für Einrichtungen des Gesundheitswesens und alle anderen Einrichtungen, in denen Medizinprodukte verpackt und sterilisiert werden.
Dieser Teil von ISO 11607 erfasst nicht alle Anforderungen für die Verpackung von aseptisch hergestellten Medizinprodukten. Auch für Kombinationen von Medikamenten und Medizinprodukten können zusätzliche Anforderungen erforderlich sein.

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage (ISO 11607-2:2006, y compris Amd 1:2014)

L'ISO 11607-2:2006 spécifie les exigences pour la mise au point et la validation des procédés d'emballage de dispositifs médicaux qui sont stérilisés au stade terminal. Ces procédés comprennent le formage, le scellage et l'assemblage de systèmes de barrière stérile préformés, de systèmes de barrière stérile et de systèmes d'emballage.
L'ISO 11607-2:2006 s'applique à l'industrie, aux installations de santé et à tout lieu où les dispositifs médicaux sont emballés et stérilisés.
L'ISO 11607-2:2006 ne couvre pas toutes les exigences relatives aux dispositifs médicaux fabriqués de manière aseptique. Des exigences supplémentaires sont nécessaires pour garantir les combinaisons médicaments/dispositifs.

Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Zahteve za validacijo pri procesih oblikovanja, označevanja in sestavljanja (ISO 11607-2:2006)

ISO 11607-2:2006 podaja zahteve za razvoj in validacijo procesov za embalažo medicinskih pripomočkov, ki so končno sterilizirani. Ti procesi vključujejo oblikovanje, označevanje in sestavljanje izvedenih sterilnih pregradnih sistemov, sterilnih pregradnih sistemov in sistemov embalaže.
ISO 11607-2:2006 se uporablja za industrijo, zdravstvene ustanove in vse medicinske pripomočke, ki so dani v embalažo in sterilizirani.
ISO 11607-2:2006 ne zajema vseh zahtev za embalažo medicinskih pripomočkov, ki so izdelani aseptično. Za kombinacije zdravil/pripomočkov so morda potrebne dodatne zahteve.

General Information

Status
Withdrawn
Publication Date
18-Jul-2017
Withdrawal Date
14-Jan-2020
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
15-Jan-2020

Relations

Buy Standard

Standard
EN ISO 11607-2:2017
English language
26 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11607-2:2017
01-september-2017
1DGRPHãþD
SIST EN ISO 11607-2:2006
SIST EN ISO 11607-2:2006/A1:2014
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO=DKWHYH]D
YDOLGDFLMRSULSURFHVLKREOLNRYDQMDR]QDþHYDQMDLQVHVWDYOMDQMD ,62
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for
forming, sealing and assembly processes (ISO 11607-2:2006)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2:
Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des
Zusammenstellens (ISO 11607-2:2006)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de
validation pour les procédés de formage, scellage et assemblage (ISO 11607-2:2006)
Ta slovenski standard je istoveten z: EN ISO 11607-2:2017
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-2:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 11607-2:2017

---------------------- Page: 2 ----------------------

SIST EN ISO 11607-2:2017


EN ISO 11607-2
EUROPEAN STANDARD

NORME EUROPÉENNE

July 2017
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN ISO 11607-2:2006
English Version

Packaging for terminally sterilized medical devices - Part
2: Validation requirements for forming, sealing and
assembly processes (ISO 11607-2:2006)
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 2: Exigences de validation pour les sterilisierende Medizinprodukte - Teil 2:
procédés de formage, scellage et assemblage (ISO Validierungsanforderungen an Prozesse der
11607-2:2006) Formgebung, Siegelung und des Zusammenstellens
(ISO 11607-2:2006)
This European Standard was approved by CEN on 18 July 2017.

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, Serbia, 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
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-2:2017 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 11607-2:2017
EN ISO 11607-2:2017 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
Annex ZB (informative) Relationship between this European Standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered . 7
Annex ZC (informative) Relationship between this European Standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered . 9

2

---------------------- Page: 4 ----------------------

SIST EN ISO 11607-2:2017
EN ISO 11607-2:2017 (E)
European foreword
The text of ISO 11607-2:2006 has been prepared by Technical Committee ISO/TC 198 "Sterilization of
health care products” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 11607-2:2017 by Technical Committee CEN/TC 102 “Sterilizers and associated
equipment for processing of medical devices” the secretariat of which is held by DIN.
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 January 2018, and conflicting national standards shal
...

Questions, Comments and Discussion

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