SIST EN ISO 15378:2018/A1:2024

SLOVENSKI STANDARD
01-november-2024
Primarni embalažni materiali za zdravila - Posebne zahteve za uporabo ISO
9001:2015 v povezavi z dobro proizvodno prakso (DPP) - Dopolnilo 1: Upoštevanje
podnebnih sprememb (ISO 15378:2017/Amd 1:2024)
Primary packaging materials for medicinal products - Particular requirements for the
application of ISO 9001:2015, with reference to good manufacturing practice (GMP) -
Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024)
Primärpackmittel für Arzneimittel - Besondere Anforderungen für die Anwendung von
ISO 9001:2015 entsprechend der Guten Herstellungspraxis (GMP) - Änderung 1:
Ergänzung zu klimabezogenen Maßnahmen (ISO 15378:2017/Amd 1:2024)
Articles d'emballage primaire pour médicaments - Exigences particulières pour
l'application de l'ISO 9001:2015 prenant en considération les Bonnes Pratiques de
Fabrication (BPF) - Amendement 1: Actions relatives aux changements climatiques (ISO
15378:2017/Amd 1:2024)
Ta slovenski standard je istoveten z: EN ISO 15378:2017/A1:2024
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.040.01 Medicinska oprema na Medical equipment in general
splošno
55.020 Pakiranje in distribucija blaga Packaging and distribution of
na splošno goods in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 15378:2017/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2024
EUROPÄISCHE NORM
ICS 03.100.70; 11.040.01
English Version
Primary packaging materials for medicinal products -
Particular requirements for the application of ISO
9001:2015, with reference to good manufacturing practice
(GMP) - Amendment 1: Climate action changes (ISO
15378:2017/Amd 1:2024)
Articles d'emballage primaire pour médicaments - Primärpackmittel für Arzneimittel - Besondere
Exigences particulières pour l'application de l'ISO Anforderungen für die Anwendung von ISO 9001:2015
9001:2015 prenant en considération les Bonnes entsprechend der Guten Herstellungspraxis (GMP) -
Pratiques de Fabrication (BPF) - Amendement 1: Änderung 1: Ergänzung zu klimabezogenen
Actions relatives aux changements climatiques (ISO Maßnahmen (ISO 15378:2017/Amd 1:2024)
15378:2017/Amd 1:2024)
This amendment A1 modifies the European Standard EN ISO 15378:2017; it was approved by CEN on 2 September 2024.

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, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15378:2017/A1:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 15378:2017/Amd 1:2024 has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use” of the International Organization for Standardization (ISO) and has been taken over as
This Amendment to the European Standard EN ISO 15378:2017 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by March 2025, and
conflicting national standards shall be withdrawn at the latest by March 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
follo
...