PD ISO/TS 23128:2019
Medical devices. Transfusion set and blood bag compatibility test method
Standard number: | PD ISO/TS 23128:2019 |
Pages: | 18 |
Released: | 2019-12-20 |
ISBN: | 978 0 539 06514 5 |
Status: | Standard |
PD ISO/TS 23128:2019 - Medical Devices: Transfusion Set and Blood Bag Compatibility Test Method
Standard Number: PD ISO/TS 23128:2019
Pages: 18
Released: December 20, 2019
ISBN: 978 0 539 06514 5
Status: Standard
Overview
The PD ISO/TS 23128:2019 is a crucial standard for ensuring the compatibility of medical devices, specifically focusing on transfusion sets and blood bags. This standard provides a comprehensive test method to ensure that these medical devices work harmoniously, ensuring patient safety and the efficacy of blood transfusions.
Importance of Compatibility Testing
In the medical field, the compatibility between transfusion sets and blood bags is of paramount importance. Incompatible devices can lead to serious complications, including hemolysis, contamination, and even life-threatening situations. The PD ISO/TS 23128:2019 standard addresses these concerns by providing a detailed methodology for testing compatibility, thus ensuring that healthcare providers can trust the equipment they use.
Key Features of the Standard
- Comprehensive Testing Methodology: The standard outlines a detailed procedure for testing the compatibility of transfusion sets and blood bags, ensuring that all potential issues are identified and addressed.
- Focus on Safety: By adhering to this standard, manufacturers and healthcare providers can significantly reduce the risk of adverse events related to blood transfusions.
- International Recognition: As an ISO standard, PD ISO/TS 23128:2019 is recognized globally, facilitating international trade and cooperation in the medical device industry.
Who Should Use This Standard?
This standard is essential for a wide range of stakeholders in the healthcare and medical device industries, including:
- Medical Device Manufacturers: To ensure their products meet international safety and compatibility standards.
- Healthcare Providers: To select the most reliable and safe equipment for blood transfusions.
- Regulatory Bodies: To establish guidelines and regulations that protect patient safety.
Benefits of Implementing PD ISO/TS 23128:2019
Implementing this standard offers numerous benefits, including:
- Enhanced Patient Safety: By ensuring compatibility, the risk of transfusion-related complications is minimized.
- Improved Product Quality: Manufacturers can enhance the quality and reliability of their products by adhering to this standard.
- Increased Trust: Healthcare providers and patients can have greater confidence in the safety and efficacy of medical devices.
Conclusion
The PD ISO/TS 23128:2019 standard is an essential tool for ensuring the compatibility and safety of transfusion sets and blood bags. By providing a detailed test method, it helps manufacturers, healthcare providers, and regulatory bodies work together to enhance patient safety and improve the quality of medical devices. Adopting this standard is a proactive step towards achieving excellence in healthcare delivery and patient care.
PD ISO/TS 23128:2019
This standard PD ISO/TS 23128:2019 Medical devices. Transfusion set and blood bag compatibility test method is classified in these ICS categories:
- 11.040.20 Transfusion, infusion and injection equipment
This document details suitable equipment, a test method, acceptance criteria and advisable limits to help to ensure that there is compatibility (by measuring the insertion force) between a transfusion set closure piercing device (referred to in this document by the abbreviation 'spike') and a blood bag outlet port.
The test procedure in its entirety is complex and beyond the scope of each of the relevant transfusion set and blood bag standards. This document was therefore developed to support the implementation of the existing standards for blood bags and transfusion sets.
The procedure described in this document can be used by manufacturers of blood bags to test the compatibility with transfusion set spikes available on the market or by manufacturers of the transfusion set spikes to test the compatibility with blood bags available on the market.