This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
Status: PublishedPublication date: 2023-01
Edition: 4Number of pages: 12
Technical Committee: ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
- ICS :
- 11.040.20 Transfusion, infusion and injection equipment
This standard contributes to the following Sustainable Development Goal:
Buy this standard
|std 1 61||PDF + ePub|
|std 2 61||Paper|
ISO 8536-2:2023Stage: 60.60
Got a question?
Check out our FAQs
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)
Keep up to date with ISO
Sign up to our newsletter for the latest news, views and product information.