ISO 15137:2005 PDF

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

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Title (English):

ISO 15137:2005

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

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 7
Publication date:: July 22, 2005
Edition:: ISO IS 15137 edition 1 version 1
ICS:: 11.040.20

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Document language:

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Description (English):

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.

Technical details

Technical committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
SKU: ISO 15137:2005

Abstract

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:

Related standards

Mentioned in the description and other ISO standards

Overview

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:

ISO 15137:2005 PDF

Technical details

Abstract

Overview

Key topics and requirements

Test weights depend on container volume:

Related standards

Abstract

Overview

Key topics and requirements

Test weights depend on container volume:

Related standards

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