ISO 13926-2:2017 PDF

Name: ISO 13926-2:2017 — Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use
SKU: ISO 13926-2:2017
Price: 25 EUR
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Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use

Название (английский):

ISO 13926-2:2017

Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 7
Дата публикации:: 28 ноября 2017 г.
Издание:: ISO IS 13926 edition 3 version 1
ICS:: 11.040.25

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Описание (английский):

ISO 13926-2:2017 specifies the material, performance requirements and labelling and gives recommendations for shape and dimensions of plunger stoppers for pen-injectors for medical use. 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.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 13926-2:2017 defines requirements for plunger stoppers for pen-injectors for medical use. The standard covers material, performance, labelling and gives recommended shapes and dimensions for elastomeric plunger stoppers that form the primary contact surface between drug and container. It emphasises the role of primary packaging in maintaining potency, purity, stability and safety of medicinal products.

Key topics and technical requirements

Scope and classification: Plunger stoppers are classified as Type A1 (with ribs), A2 (without ribs) and A3 (with ribs and dome).

Shape & dimensions: Typical dimensional examples are provided; final dimensions (including heights and certain diameters) are agreed between manufacturer and user. Spacers to prevent adhesion are required (height ≤ 0.3 mm).

Materials: Elastomeric formulations must be those originally tested and approved by the end user. Materials must withstand two autoclave cycles at (121 ± 2) °C for 30 min without functional impairment; alternative sterilization routes must be evaluated.

Physical performance:

Hardness: Agreed nominal hardness ±5 Shore A (or ±5 IRHD if tested per ISO 48) on appropriate test specimens (ISO 7619-1 referenced).
Freedom from leakage: Cartridges must be leak-free at the plunger when tested per the Annex A leakage test (force is calculated using the glass cylinder inner diameter and a correction factor of 0.64 N/mm²).
Initiating/sustaining forces and resistance to ageing: Requirements reference system-level testing and stability validation; shelf-life performance must be demonstrated by the medicinal product stability programme.

Chemical & biological: Extractables/chemical and biological requirements reference ISO 8871-1 and ISO 8871-4.

Labelling & designation: Standardized designation format (example: “Plunger ISO 13926-2 – 6,85 – A1”) for compliant packed plungers.

Applications and who uses this standard

ISO 13926-2:2017 is used by:

Manufacturers of pen-injector plunger stoppers and elastomeric components

Pen-injector system designers and drug-device combination developers

Pharmaceutical formulation and primary packaging teams validating container-closure compatibility

Quality, regulatory and contract testing laboratories performing physical, chemical and biological testing

Suppliers of glass cylinders and seals who must validate compatibility per ISO 11608-3

Practical applications include component specification, supplier contracts, product validation, leakage testing, sterilization qualification and stability programmes for drug-delivery systems.

Related standards

ISO 13926-1 (glass cylinders for pen-injectors)

ISO 13926-3 (seals for pen-injectors)

ISO 11608-3 (finished containers, needle-based injection systems)

ISO 8871-1, ISO 8871-4 (elastomeric extractables & biological)

ISO 7619-1, ISO 3302-1, ISO 2230, ISO 15378

Keywords: ISO 13926-2:2017, plunger stoppers, pen-injectors, elastomeric materials, leakage test, primary packaging, medical device standards.

ISO 13926-2:2017 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses this standard

Related standards

Технические детали

ISO 4885:2026

Ferrous materials — Heat treatments — Vocabulary

ISO 7619-1:2004/Amd 1:2008

Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1: Durometer method (Shore…

SIST EN ISO 8871-1:2005

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous au…

SIST EN ISO 8871-4:2006

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements an…

BS ISO 13926-2:2017

Pen systems. Plunger stoppers for pen-injectors for medical use.

EN ISO 11608-3:2022/A1:2026

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

ISO 13926-1:2004

Pen systems — Part 1: Glass cylinders for pen-injectors for medical use

BS ISO 13926-3:2019-TC

Tracked Changes. Pen systems. Seals for pen-injectors for medical use.