ISO 15137:2005

Name: ISO 15137:2005 — Self-adhesive hanging devices for infusion bottles and injection vials — Requirements and test methods
SKU: ISO 15137:2005
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Self-adhesive hanging devices for infusion bottles and injection vials — Requirements and test methods

Название (английский):

ISO 15137:2005

Self-adhesive hanging devices for infusion bottles and injection vials — Requirements and test methods

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 7
Дата публикации:: 22 июля 2005 г.
Издание:: ISO IS 15137 edition 1 version 1
ICS:: 11.040.20

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Описание (английский):

ISO 15137:2005 specifies requirements and test methods for self-adhesive hanging devices (SAHD) used in combination with infusion containers, e.g. infusion glass bottles (see ISO 8536-1). The purpose of ISO 15137:2005 is to establish a safe SAHD for prescribed infusion containers while administering their content so as to ensure a safe application for the patient and for the user.

Abstract

Похожие стандарты

Упомянутые в описании и другие стандарты ISO

Overview

ISO 15137:2005 - "Self-adhesive hanging devices for infusion bottles and injection vials - Requirements and test methods" defines safety, performance and test requirements for self-adhesive hanging devices (SAHD) used with infusion containers (for example, infusion glass bottles per ISO 8536‑1). The standard ensures SAHDs provide a reliable, safe hanging solution during administration of liquid pharmaceutical products for both patient and user.

Key topics and requirements

Scope & designation

Applies to SAHDs combining an adhesive portion and a hanging portion; devices shall be marked “Self-adhesive hanging device ISO 15137”.

Materials

Materials must meet performance criteria; note that disinfection fluids or UV light can damage some materials.

Surface and attachment

Infusion container surface must be clean, dry and free of release agents.
At least 95% of the adhesive area must contact the container; avoid wrinkles or bubbles.

Load resistance

Permanent load test: must not break or detach under specified load for 24 h.
Short-term load test: must hold for 30 s under higher short-term load.
Gravitational (fall) test: container hung and dropped 30 cm must not cause breakage or detachment.
Test weights depend on container volume:
- < 250 ml: permanent load 3 kg, short-term 6 kg
- 250–1 000 ml: permanent load 5 kg, short-term 6 kg

Elongation and positioning

Distance between hook and container must not increase by more than 50% after loading.
Hanging portion must keep container vertical within 10°.

Water resistance

Immersion in water bath at (40 ± 3) °C for 24 h, then meet load and elongation requirements.

Environmental conditions for testing

Tests at (23 ± 3) °C and (50 ± 10)% relative humidity.

Durability and storage

Long-term performance: SAHD must comply for 6 years after attachment (or until product expiry) if stored appropriately (no UV, 10–30 °C).
Shelf life before attachment: at least 2 years, with manufacturer-specified storage.

Manufacturer information

Required data: curing time, shelf life, storage conditions.

Applications and users

ISO 15137 is essential for:

SAHD manufacturers (design, test and label compliance)

Medical device test laboratories (performing load, elongation and water-resistance tests)

Quality assurance and regulatory teams (design dossiers, CE/market submissions)

Hospital procurement and clinical engineering (specifying safe SAHDs for infusion bottles and vials)

Device designers integrating adhesive hanging solutions into infusion systems

Related standards

ISO 8536‑1 - Infusion glass bottles (related infusion containers)

ISO 2768‑1 - General tolerances (referenced for dimensions)

Keywords: ISO 15137:2005, self-adhesive hanging device, SAHD, infusion bottles, injection vials, requirements and test methods, load resistance, water resistance, medical device standards.

ISO 15137:2005

Abstract

Похожие стандарты

Overview

Key topics and requirements

Applications and users

Related standards

Технические детали

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