BS ISO 17593:2022 - Clinical Laboratory Testing and In Vitro Medical Devices

Standard Number: BS ISO 17593:2022

Pages: 62

Released: 2022-03-15

ISBN: 978 0 539 06446 9

Status: Standard

Overview

The BS ISO 17593:2022 standard is a comprehensive guideline that sets forth the requirements for in vitro monitoring systems used for self-testing of oral anticoagulant therapy. This standard is essential for ensuring the accuracy, reliability, and safety of these medical devices, which are crucial for patients who require regular monitoring of their anticoagulant levels.

Key Features

• Comprehensive Coverage: With 62 pages of detailed requirements, this standard provides an exhaustive framework for the development and use of in vitro monitoring systems.
• Up-to-Date Information: Released on March 15, 2022, this standard incorporates the latest advancements and best practices in the field of clinical laboratory testing and in vitro medical devices.
• Global Relevance: As an ISO standard, it is recognized and applicable worldwide, making it a valuable resource for manufacturers, healthcare providers, and regulatory bodies.
• Patient Safety: Emphasizes the importance of accuracy and reliability in self-testing devices, thereby ensuring patient safety and effective management of oral anticoagulant therapy.

Why Choose BS ISO 17593:2022?

Oral anticoagulant therapy is a critical treatment for many patients, and accurate monitoring is essential to avoid complications such as bleeding or thrombosis. The BS ISO 17593:2022 standard provides a robust framework to ensure that in vitro monitoring systems are reliable and user-friendly, making self-testing a viable option for patients.

Ensuring Accuracy and Reliability

One of the primary goals of this standard is to ensure that in vitro monitoring systems provide accurate and reliable results. This is achieved through stringent requirements for device performance, including precision, accuracy, and consistency. By adhering to these guidelines, manufacturers can develop devices that patients can trust.

Enhancing Patient Safety

Patient safety is at the forefront of the BS ISO 17593:2022 standard. It outlines specific requirements for the design and functionality of self-testing devices to minimize the risk of errors and ensure that patients can use them safely and effectively. This includes guidelines for user instructions, device maintenance, and troubleshooting.

Facilitating Regulatory Compliance

For manufacturers, compliance with the BS ISO 17593:2022 standard is a crucial step in meeting regulatory requirements. This standard is recognized by regulatory bodies worldwide, making it easier for manufacturers to gain approval for their devices and bring them to market. It also provides a clear framework for quality assurance and risk management.

Who Should Use This Standard?

The BS ISO 17593:2022 standard is designed for a wide range of stakeholders in the healthcare and medical device industries, including:

• Manufacturers: Companies that develop and produce in vitro monitoring systems for self-testing of oral anticoagulant therapy.
• Healthcare Providers: Medical professionals who oversee the use of these devices and provide guidance to patients.
• Regulatory Bodies: Organizations responsible for approving and monitoring medical devices to ensure they meet safety and performance standards.
• Patients: Individuals who use self-testing devices to monitor their oral anticoagulant therapy.

Conclusion

The BS ISO 17593:2022 standard is an essential resource for anyone involved in the development, regulation, or use of in vitro monitoring systems for self-testing of oral anticoagulant therapy. By providing a comprehensive set of requirements, this standard ensures that these devices are accurate, reliable, and safe, ultimately improving patient outcomes and enhancing the quality of care.

With its detailed guidelines and up-to-date information, the BS ISO 17593:2022 standard is a valuable tool for ensuring the highest standards of quality and safety in the field of clinical laboratory testing and in vitro medical devices.

BS ISO 17593:2022

This standard BS ISO 17593:2022 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy is classified in these ICS categories:

• 11.100.20 Biological evaluation of medical devices
• 11.100.10 In vitro diagnostic test systems