Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO/DIS 8536-5:2025)

Comment end date 2025-12-18

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Project stage codes

1. Prioritetinių darbo temų pažymėjimas ir ekspertų skyrimas

2. Projektas

3. Viešoji apklausa

From 2025-10-19 till 2025-12-18

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

2025-10-19

Scope

ISO 8536-5:2004 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment. ISO 8536-5:2004 also provides guidance on specifications relating to the quality and performance of materials. In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-5:2004.

Relations

Pakeis

prEN ISO 8536-5