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prEN ISO 8871-5

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO/DIS 8871-5:2024)

Draft Archived
Comment end date 2024-07-10

Project stage codes

1. Decision on WI Proposal
2. Projektas
3. Viešoji apklausa
From 2024-05-02 till 2024-07-10
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

0

Comment start date

2024-05-02

Scope

ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle. NOTE Functional testing with spikes is specified in ISO 8536‑2 and in ISO 8536‑6.

Relations

Pakeis
LST EN ISO 8871-5:2017