EN ISO 11607-2:2020/A11:2022
(Amendment)Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
This document specifies requirements for the 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.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can 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 2:2019/A11:2020)
Dieses Dokument legt Anforderungen für die Entwicklung und Validierung von Verpackungsprozessen für Medizinprodukte fest, die in der Endverpackung sterilisiert werden. Zu diesen Verfahren gehören die Formung, Siegelung und das Zusammenstellen von vorgefertigten Sterilbarrieresystemen, Steril-barrieresystemen und Verpackungssystemen.
Es gilt für die Industrie, für Einrichtungen des Gesundheitswesens und für alle anderen Einrichtungen, in denen Medizinprodukte verpackt und sterilisiert werden.
Es deckt nicht alle Anforderungen an Verpackungen aseptisch hergestellter Medizinprodukte ab. 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 11607-2:2019)
Le présent document 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.
Il s'applique à l'industrie, aux établissements de santé et à tout lieu où les dispositifs médicaux sont emballés et stérilisés.
Il ne couvre pas toutes les exigences relatives à l'emballage des dispositifs médicaux fabriqués de manière aseptique. Des exigences supplémentaires peuvent être nécessaires pour garantir les combinaisons médicaments/dispositifs.
Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Zahteve za validacijo pri procesih oblikovanja, označevanja in sestavljanja - Dopolnilo A11 (ISO 11607-2:2019)
Ta dokument 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. Uporablja se za industrijo, zdravstvene ustanove in vse medicinske pripomočke, ki so dani v embalažo in sterilizirani. Ne zajema vseh zahtev za embalažo medicinskih pripomočkov, ki so izdelani aseptično. Za kombinacije zdravil/pripomočkov so morda potrebne dodatne zahteve.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11607-2:2020/A11:2022
01-september-2022
Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Zahteve za
validacijo pri procesih oblikovanja, označevanja in sestavljanja - Dopolnilo A11
(ISO 11607-2:2019)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for
forming, sealing and assembly processes (ISO 11607-2:2019)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2:
Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des
Zusammenstellens (ISO 11607-2:2019)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de
validation pour les procédés de formage, scellage et assemblage (ISO 11607-2:2019)
Ta slovenski standard je istoveten z: EN ISO 11607-2:2020/A11:2022
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-2:2020/A11:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11607-2:2020/A11:2022
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SIST EN ISO 11607-2:2020/A11:2022
EN ISO 11607-
EUROPEAN STANDARD
2:2020/A11
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2022
ICS 11.080.30
English Version
Packaging for terminally sterilized medical devices - Part
2: Validation requirements for forming, sealing and
assembly processes (ISO 11607-2:2019)
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
11607-2:2019) Formgebung, Siegelung und des Zusammenstellens
(ISO 11607-2:2019)
This amendment A11 modifies the European Standard EN ISO 11607-2:2020; it was approved by CEN on 13 April 2022.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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, 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, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-2:2020/A11:2022 E
worldwide for CEN national Members.
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SIST EN ISO 11607-2:2020/A11:2022
EN ISO 11607-2:2020/A11:2022
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] (as amended) 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] (as amended) aimed to be covered . 8
Annex ZC (informative) Relationship between this European Standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered . 10
2
---------------------- Page: 4 ----------------------
SIST EN ISO 11607-2:2020/A11:2022
EN ISO 11607-2:2020/A11:2022
European foreword
This document (EN ISO 11607-2:2020/A11:2022) has been prepared by Technical Committee
CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices”, the secretariat of
which is held by DIN.
This Amendment to the European Standard EN ISO 11607-2:2020 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by December 2022,
and conflicting national standards shall be withdrawn at the latest by December 2022.
Attention is drawn to the possibility that some of th
...
SLOVENSKI STANDARD
SIST EN ISO 11607-2:2020/A11:2022
01-september-2022
Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Zahteve za
validacijo pri procesih oblikovanja, označevanja in sestavljanja - Dopolnilo A11
(ISO 11607-2:2019)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for
forming, sealing and assembly processes (ISO 11607-2:2019)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2:
Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des
Zusammenstellens (ISO 11607 2:2019/A11:2020)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de
validation pour les procédés de formage, scellage et assemblage (ISO 11607-2:2019)
Ta slovenski standard je istoveten z: EN ISO 11607-2:2020/A11:2022
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-2:2020/A11:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 11607-2:2020/A11:2022
---------------------- Page: 2 ----------------------
SIST EN ISO 11607-2:2020/A11:2022
EN ISO 11607-
EUROPEAN STANDARD
2:2020/A11
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2022
ICS 11.080.30
English Version
Packaging for terminally sterilized medical devices - Part
2: Validation requirements for forming, sealing and
assembly processes (ISO 11607-2:2019)
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
11607-2:2019) Formgebung, Siegelung und des Zusammenstellens
(ISO 11607-2:2019)
This amendment A11 modifies the European Standard EN ISO 11607-2:2020; it was approved by CEN on 13 April 2022.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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, 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, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-2:2020/A11:2022 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 11607-2:2020/A11:2022
EN ISO 11607-2:2020/A11:2022
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] (as amended) 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] (as amended) aimed to be covered . 8
Annex ZC (informative) Relationship between this European Standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered . 10
2
---------------------- Page: 4 ----------------------
SIST EN ISO 11607-2:2020/A11:2022
EN ISO 11607-2:2020/A11:2022
European foreword
This document (EN ISO 11607-2:2020/A11:2022) has been prepared by Technical Committee
CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices”, the secretariat of
which is held by DIN.
This Amendment to the European Standard EN ISO 11607-2:2020 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by December 2022,
and conflicting national standards shall be withdrawn at the latest by December 2022.
Attention is drawn to the possibility that s
...
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