Standard Swedish standard · SS-EN ISO 8536-2:2010

Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010)

Status: Valid

Scope
This part of ISO 8536 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 part of ISO 8536 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.

Subjects

Transfusion, infusion and injection equipment (11.040.20)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-73652

Edition: 2

Approved: 3/25/2010

No of pages: 24

Replaces: SS-EN ISO 8536-2/AC:2005 , SS-EN ISO 8536-2