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SSH EN ISO 15747:2019

Konteinerët plastike për injeksionin intravenoz (ISO 15747:2018)

Plastic containers for intravenous injections (ISO 15747:2018)
2 pri 2020

General information

60.60     1 pri 2020

DPS

DPS/KT 316

European Norm

11.040.20  

anglisht  

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Scope

This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.

Related directives

Directives related to this standards.

93/42/EEC

Pajisje Mjekësore

Të harmonizuara
Directive 93/42/EEC
2007/47/EC

Direktiva 2007/47/EC e Parlamentit Europian dhe e Këshillit të 5 shtator 2007 amendon Direktivën e Këshillit 90/385/EEC mbi përafrimin e ligjeve të Shteteve Anëtare në lidhje me pajisje medicinale aktive transplatuese, Direktiva e Këshillit 93/42/EEC në lidhje me pajisjet mjekësore dhe Direktivën 98/8/EC në lidhje me vendosjen e produkteve biocide në treg

Directive 2007/47/EC

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 15747:2011

NOW

PUBLISHED
SSH EN ISO 15747:2019
60.60 Standard published
1 pri 2020

Related project

Adopted from EN ISO 15747:2019