ISO 8536-6:2025

International Standard   Current Edition · Approved on 27 March 2025

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

ISO 8536-6:2025 Files

English 16 Pages
Current Edition
OMR 47.59

ISO 8536-6:2025 Scope

This document 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.

NOTE         The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.

Best Sellers

GSO 150-2:2013
 
Gulf Standard
Expiration dates for food products - Part 2 : Voluntary expiration dates
OS GSO 150-2:2013
GSO 150-2:2013 
Omani Standard
Expiration dates for food products - Part 2 : Voluntary expiration dates
OS GSO 9:2022
GSO 9:2022 
Omani Standard
Labeling of prepackaged food stuffs
GSO 9:2022
 
Gulf Technical Regulation
Labeling of prepackaged food stuffs

Recently Published

ISO 5183-1:2026
 
International Standard
Resistance welding equipment — Electrode adaptors, male taper 1:10 — Part 1: Conical fixing, taper 1:10
ISO 21384-3:2026
 
International Standard
Uncrewed aircraft systems — Part 3: Operational procedures
ISO 10993-3:2026
 
International Standard
Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity
ISO/IEC 30178:2026
 
International Standard
Internet of Things (IoT) — Data format, value and coding for interoperability