SSH ISO 8536-6:2016

Pajisje infuzioni për përdorim mjekësor - Pjesa 6: Mbyllje liofilitike për shishet e injeksionit

Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles

Publication date: 25 pri 2017

General information

Current stage: 60.60 Effective date: 17 jan 2017

Originator: DPS

Owner: DPS/KT 205

Type: International Standard

ICS: 11.040.20

Gjuha: anglisht

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Statusi: Publikuar

PDF - 2 915 Lekë

Paper - 2 915 Lekë

CD - 2 915 Lekë

PDF and Paper - 5 830 Lekë

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Scope

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.

SSH ISO 8536-6:2016

Pajisje infuzioni për përdorim mjekësor - Pjesa 6: Mbyllje liofilitike për shishet e injeksionit

Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles

General information

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Scope

Life cycle

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Adopted from ISO 8536-6:2016