ISO/PRF 8536-6

This draft is in the approval phase.

Will replace ISO 8536-6:2016

Abstract

ISO 8536-6:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials.

The dimensional requirements are not applicable to barrier-coated closures.

Closures specified in this document are intended for single use only.

General information

Status
: Under development

Stage
: Final text received or FDIS registered for formal approval [50.00]
Edition
: 4
Technical Committee :
ISO/TC 76

ICS :
11.040.20
RSS updates