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B51-14 (R2019) – Boiler, pressure vessel, and pressure piping code

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ISO 8536:2023

ISO 8536:2023 Infusion equipment for medical use – Part 2: Closures for infusion bottles

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Description

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.

Edition

4

Published Date

2023-01-31

Status

PUBLISHED

Pages

12

Language Detail Icon

English

Format Secure Icon

Secure PDF

Abstract

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.

Previous Editions

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