BS ISO 28620:2020 - Medical Devices: Non-electrically Driven Portable Infusion Devices

Introducing the BS ISO 28620:2020, a comprehensive standard that sets the benchmark for non-electrically driven portable infusion devices. Released on January 20, 2020, this standard is an essential resource for manufacturers, healthcare professionals, and regulatory bodies involved in the design, production, and use of medical infusion devices.

Overview

The BS ISO 28620:2020 standard provides detailed guidelines and specifications for non-electrically driven portable infusion devices. These devices are crucial in various medical settings, offering a reliable and efficient means of delivering fluids, medication, or nutrients to patients without the need for electrical power. This makes them particularly valuable in emergency situations, remote locations, or areas with limited access to electricity.

Key Features

• Standard Number: BS ISO 28620:2020
• Pages: 20
• Release Date: January 20, 2020
• ISBN: 978 0 580 99682 5
• Status: Standard

Why Choose BS ISO 28620:2020?

The BS ISO 28620:2020 standard is designed to ensure the highest level of safety, performance, and reliability for non-electrically driven portable infusion devices. By adhering to this standard, manufacturers can guarantee that their products meet international quality and safety requirements, providing peace of mind to healthcare providers and patients alike.

Benefits of Compliance

Compliance with the BS ISO 28620:2020 standard offers numerous benefits, including:

• Enhanced Safety: Ensures that devices are safe for use in various medical environments, reducing the risk of malfunctions or adverse events.
• Improved Performance: Sets performance benchmarks that devices must meet, ensuring consistent and reliable operation.
• Global Recognition: As an internationally recognized standard, compliance facilitates market access and acceptance worldwide.
• Regulatory Compliance: Helps manufacturers meet regulatory requirements in different regions, streamlining the approval process.

Applications

Non-electrically driven portable infusion devices are used in a wide range of medical applications, including:

• Emergency Medicine: Providing rapid infusion of fluids or medications in emergency situations where electrical power may not be available.
• Home Healthcare: Allowing patients to receive necessary treatments at home, improving comfort and convenience.
• Field Hospitals: Essential in military or disaster relief settings where traditional medical infrastructure is unavailable.
• Remote Locations: Ideal for use in rural or remote areas with limited access to electricity.

Who Should Use This Standard?

The BS ISO 28620:2020 standard is invaluable for a variety of stakeholders, including:

• Manufacturers: Ensures that products meet international standards, enhancing marketability and consumer trust.
• Healthcare Providers: Offers guidance on selecting and using devices that meet the highest safety and performance standards.
• Regulatory Bodies: Provides a framework for evaluating and approving non-electrically driven portable infusion devices.
• Researchers and Developers: Aids in the design and development of innovative infusion solutions that comply with global standards.

Conclusion

The BS ISO 28620:2020 standard is a vital tool for ensuring the quality, safety, and effectiveness of non-electrically driven portable infusion devices. By adhering to this standard, stakeholders can contribute to improved patient outcomes and enhanced healthcare delivery worldwide. Whether you are a manufacturer, healthcare provider, or regulatory authority, the BS ISO 28620:2020 standard is an indispensable resource for navigating the complexities of medical device compliance and innovation.

BS ISO 28620:2020

This standard BS ISO 28620:2020 Medical devices. Non-electrically driven portable infusion devices is classified in these ICS categories:

• 11.040.20 Transfusion, infusion and injection equipment

This document specifies essential requirements and related test methods for non-electrically driven portable infusion devices, thereafter called “device”.

It is applicable to devices designed for continuous (fixed or adjustable) flow and/or for bolus neuraxial and intravascular or hypodermic applications.

These devices can be used in health care and non-health care settings. They can be applied or administered by health care professionals or by the intended patient.

These devices can be pre-filled by the manufacturer or filled before use by a health care professional or the intended patient.

This document does not apply to

• electrically driven or electrically controlled infusion pumps that are covered by IEC 60601-2-24 ,

• devices for single patient use intended to deliver discrete volumes (bolus) of medicinal product that are covered by the ISO 11608 series ,

• implantable devices,

• enteral devices,

• transdermal delivery devices, and

• devices where the energy for infusion is not provided by the device or through active intervention by the patient (e.g. devices only powered by gravity).