ISO 8536-2:2023 PDF

Infusion equipment for medical use — Part 2: Closures for infusion bottles

Название (английский):

ISO 8536-2:2023

Infusion equipment for medical use — Part 2: Closures for infusion bottles

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 12
Дата публикации:: 31 января 2023 г.
Издание:: ISO IS 8536 edition 4 version 1
ICS:: 11.040.20

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Описание (английский):

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.

Технические детали

Технический комитет: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
SKU: ISO 8536-2:2023

Abstract

Overview

ISO 8536-2:2023 - "Infusion equipment for medical use - Part 2: Closures for infusion bottles" specifies the shape, dimensions, materials, performance requirements and labelling of elastomeric closures used on infusion bottles. The standard applies to single‑use infusion closures (types A and B) and complements ISO 8536-1 (infusion glass bottles). Dimensional rules exclude barrier‑coated closures. The document also includes normative test methods (Annexes A–D) for fragmentation, spike penetration, spike retention/sealability and the test spike design.

Key topics and technical requirements

Geometry and sizing: Defines closure shapes (types A and B) and nominal bottle sizes (examples include 28, 29 and 32 mm) with tolerances; general dimensional tolerances per ISO 3302 series.
Material and sterilization: Elastomeric formulations are specified; closures shall withstand two autoclave cycles at (121 ± 2) °C for 30 min (unless terminal sterilization applies). Manufacturers must ensure batch conformance to type samples.
Performance tests:
- Hardness: agreed nominal value ±5 IRHD (tested per ISO 48-4).
- Fragmentation: ≤20 fragments per ten piercings (Annex A).
- Spike penetration force: individual ≤80 N and average

Overview

Key topics and technical requirements

Geometry and sizing: Defines closure shapes (types A and B) and nominal bottle sizes (examples include 28, 29 and 32 mm) with tolerances; general dimensional tolerances per ISO 3302 series.
Material and sterilization: Elastomeric formulations are specified; closures shall withstand two autoclave cycles at (121 ± 2) °C for 30 min (unless terminal sterilization applies). Manufacturers must ensure batch conformance to type samples.
Performance tests:
- Hardness: agreed nominal value ±5 IRHD (tested per ISO 48-4).
- Fragmentation: ≤20 fragments per ten piercings (Annex A).
- Spike penetration force: individual ≤80 N and average

ISO 8536-2:2023 PDF

Технические детали

Abstract

Overview

Key topics and technical requirements

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Abstract

Overview

Key topics and technical requirements

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