Plastic containers for intravenous injections (ISO/DIS 15747:2025)

Comment end date 2025-07-17

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Project stage codes

1. Prioritetinių darbo temų pažymėjimas ir ekspertų skyrimas

2. Projektas

3. Viešoji apklausa

From 2025-05-18 till 2025-07-17

4. Closure of enquiry

5. Submission to Formal Vote

Organisation

CEN Europos standartizacijos komitetas

ICS

11.040.20 - Transfusion, infusion and injection equipment

Technical Committee

TK 32 Health

ForeignTC'S

CEN/TC 205

Number of comments

Comment start date

2025-05-18

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.

Relations

Pakeis

prEN ISO 15747