ISO 15375:2010 PDF

Name: ISO 15375:2010 — Medical infusion bottles — Suspension devices for multiple use — Requirements and test methods
SKU: ISO 15375:2010
Price: 25 EUR
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Medical infusion bottles — Suspension devices for multiple use — Requirements and test methods

Название (английский):

ISO 15375:2010

Medical infusion bottles — Suspension devices for multiple use — Requirements and test methods

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 3
Дата публикации:: 4 июня 2010 г.
Издание:: ISO IS 15375 edition 2 version 1
ICS:: 11.040.20

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Описание (английский):

ISO 15375:2010 specifies requirements for permanent suspension devices, fixed to infusion racks or set-up devices, for infusion bottles that confirm to the requirements of ISO 8536‑1. The suspension devices are intended for multiple use. The purpose of ISO 15375:2010 is to establish a safe suspension device for infusion bottles during administering of their contents.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 15375:2010 - "Medical infusion bottles - Suspension devices for multiple use - Requirements and test methods" specifies safety, design and test requirements for permanent suspension devices fixed to infusion racks or set-up devices used with infusion bottles that conform to ISO 8536‑1. The standard targets suspension devices intended for multiple use and defines how manufacturers must design, label and test these devices so infusion bottles remain secure during administration.

Key topics and requirements

Scope and designation

Applies to permanent suspension devices for infusion bottles (multiple use). Devices are identified by a designation block referencing ISO 15375 and the nominal bottle capacity (example: Suspension device ISO 15375 - M 50 - 250).

Design requirements

Must permit installation of bottles with perforated transfer sets.
Prevent unintentional removal from infusion racks or set-up devices.
Hold bottles approximately perpendicular (maximum deviation 15°).
Prevent bottle drop-off at tilts up to 45°.
Be corrosion-resistant and free from burrs.

Materials

Materials chosen must meet performance requirements and resist chemical/physical damage from disinfectants; manufacturers should select materials inert to common disinfectants and resistant to stress cracking and thermal stress.

Sterilization and cleaning

Manufacturer’s instructions must specify cleaning, sterilization and disinfection methods compatible with the device materials.

Load and life-cycle

Devices must withstand specified gravitational and permanent load tests without detaching or being damaged.
If a device has a limited life (≤ 5 years), the manufacturer must state storage conditions and usable life; assessment criteria must be provided to determine end-of-life.

Test methods

Assembly test (orientation/perpendicularity)
Sloping test (45° tilt)
Gravitational test (drop arrest test)
Permanent load test (continuous loading for 24 h with test weight defined by nominal capacity)

Applications and users

Who uses ISO 15375: manufacturers and designers of infusion equipment, medical device test laboratories, hospital procurement and biomedical engineering teams, regulatory bodies and conformity assessors.

Practical use: ensures safe, standardized suspension devices that reduce risk of bottle drop during blood transfusion and infusion of pharmaceutical solutions; helps procurement specify compliant devices and supports manufacturers in product development and labeling.

Related standards

ISO 8536‑1 - Infusion glass bottles (normative reference)

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

Prepared under ISO/TC 76 (Transfusion, infusion and injection equipment)

Keywords: ISO 15375:2010, medical infusion bottles, suspension devices, multiple use, infusion racks, test methods, ISO 8536-1, permanent suspension devices, sterilization, load tests.

ISO 15375:2010 PDF

Abstract

Похожие стандарты

Overview

Key topics and requirements

Applications and users

Related standards

Технические детали

ISO 8536-15:2022/Amd 1:2023

Infusion equipment for medical use — Part 15: Light-protective infusion sets for single use — Amendment 1

ISO 15375:2004

Hanging devices for multiple use with infusion bottles — Requirements and test methods

SIST ISO 2768-1:1999

General tolerances -- Part 1: Tolerances for linear and angular dimensions without individual tolerance indic…