SIST EN ISO 8871-5:2025 PDF

Name: SIST EN ISO 8871-5:2025 — Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2025)
SKU: SIST EN ISO 8871-5:2025
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Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2025)

Название (английский):

SIST EN ISO 8871-5:2025

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2025)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 20
Дата публикации:: 4 апреля 2025 г.
Издание:: ISO 8871-5:2025
ICS:: 11.040.20

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Описание (английский):

This document specifies requirements and test methods for functional parameters of closures used in combination with vials and when pierced by an injection needle. NOTE Functional testing with spikes is specified in ISO 8536-2, ISO 8536-6, ISO 8362-1 and ISO 8362-4.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 8871-5:2025 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing - is the CEN-adopted version of ISO 8871-5:2025. It specifies functional parameters and test methods for elastomeric closures used with vials when pierced by an injection needle. The document defines how to evaluate penetrability, fragmentation, self-sealing and dye solution tightness for closures used in pharmaceutical and parenteral applications.

Key topics and requirements

Scope: Tests apply to closures used in combination with vials and pierced by metal injection needles. Functional testing with spikes is covered by related ISO vial standards (e.g., ISO 8536-2, ISO 8536-6, ISO 8362-1, ISO 8362-4).

Main functional parameters:

Penetrability (Annex A): the force required to pierce a closure. Requirement: ≤ 10 N per closure.
Fragmentation (Annex B): formation of elastomeric particles when pierced. Acceptance: the total number of fragments from 48 piercings (4 piercings on each of 12 closures) shall be ≤ 5. Fragment size limits and test adaptations can be agreed between supplier and customer.
Self-sealing (Annex C): resealing efficiency after needle withdrawal. For multi‑dose containers, no visible dye shall be present when inspected with the naked eye.
Dye solution tightness (Annex D): verifies effective sealing of a specific closure/vial combination; no visible dye allowed in vials after test.

Test preparation: includes provisions for sampling, cleaning and sterilization of closures prior to testing (Clauses 5.1–5.3).

Normative references: includes related standards such as ISO 7864, ISO 8362 series and references to analytical guidance (ISO 11608-3, USP <788>, USP <1207>).

Practical applications

Quality control of elastomeric vial closures in pharmaceutical manufacturing.

Design verification for primary packaging used with injectable drugs and multi‑dose vials.

Supplier qualification and incoming inspection of rubber and thermoplastic elastomer (TPE) components.

Risk assessment for particulate contamination and container integrity in parenteral systems.

Related standards

ISO 8536-2, ISO 8536-6, ISO 8362-1, ISO 8362-4 (functional testing with spikes)

ISO 7864 (hypodermic needles)

ISO 11608-3, USP <788>, USP <1207> (referenced testing and particulate guidance)

EN ISO 8871-5:2025 is essential for ensuring safe, reliable elastomeric closures used in parenteral and injectable pharmaceutical products, supporting regulatory compliance and patient safety.

SIST EN ISO 8871-5:2025 PDF

Abstract

Похожие стандарты

Overview

Key topics and requirements

Practical applications

Who should use this standard

Related standards

Технические детали

ISO 8871-5:2025

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements an…

SIST EN ISO 8536-2:2023

Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2023)

ISO 8536-6:2009

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

SIST EN ISO 8362-1:2019

Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2018)

SIST EN ISO 8362-4:2011

Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:2011)

SIST EN ISO 7864:2016

Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)

SIST EN ISO 8362-2:2024

Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)

EN ISO 11608-3:2022/A1:2026

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integ…