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>BSI Standards >11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.25 Syringes, needles and catheters>BS EN ISO 23908:2025 Sharps injury protection. Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration. Requirements and test methods
immediate downloadReleased: 2025-11-06

BS EN ISO 23908:2025

Sharps injury protection. Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration. Requirements and test methods

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Standard number:BS EN ISO 23908:2025
Pages:30
Released:2025-11-06
ISBN:978 0 539 24731 2
Status:Standard

BS EN ISO 23908:2025 - Comprehensive Sharps Injury Protection Standard

In the ever-evolving landscape of healthcare, ensuring the safety of medical professionals and patients is paramount. The BS EN ISO 23908:2025 standard is a critical document that addresses the essential requirements and test methods for sharps protection mechanisms. This standard is specifically designed for single-use needles, introducers for catheters, and needles used in various medical procedures such as blood testing, monitoring, sampling, and the administration of medical substances.

Key Features of BS EN ISO 23908:2025

  • Standard Number: BS EN ISO 23908:2025
  • Pages: 30
  • Release Date: November 6, 2025
  • ISBN: 978 0 539 24731 2
  • Status: Standard

This standard is a must-have for healthcare facilities, medical device manufacturers, and safety officers who are committed to maintaining the highest levels of safety and compliance in their operations.

Why BS EN ISO 23908:2025 is Essential

Sharps injuries pose a significant risk in medical settings, potentially leading to serious infections and other health complications. The BS EN ISO 23908:2025 standard provides a comprehensive framework to mitigate these risks by outlining the necessary protective mechanisms for sharps. By adhering to this standard, healthcare providers can significantly reduce the incidence of sharps injuries, thereby enhancing the safety of both healthcare workers and patients.

Comprehensive Coverage

The standard covers a wide range of applications, including:

  • Single-use needles
  • Introducers for catheters
  • Needles used for blood testing, monitoring, and sampling
  • Needles used for the administration of medical substances

Each of these applications is critical in the medical field, and the standard ensures that the protective mechanisms are robust and effective.

Detailed Requirements and Test Methods

BS EN ISO 23908:2025 provides detailed requirements and test methods to ensure that the sharps protection mechanisms are not only effective but also reliable. The standard specifies the design, performance, and testing criteria that these mechanisms must meet to be considered compliant. This ensures that the products are safe for use in real-world medical environments.

Benefits of Implementing BS EN ISO 23908:2025

Implementing this standard offers numerous benefits, including:

  • Enhanced Safety: By following the guidelines, healthcare facilities can significantly reduce the risk of sharps injuries, protecting both staff and patients.
  • Regulatory Compliance: Adhering to the standard ensures compliance with international safety regulations, which is crucial for legal and operational reasons.
  • Improved Reputation: Facilities that prioritize safety and compliance are viewed more favorably by patients, staff, and regulatory bodies.
  • Cost Savings: Reducing the incidence of sharps injuries can lead to significant cost savings by minimizing the need for medical treatments and legal expenses associated with such injuries.

Who Should Use This Standard?

The BS EN ISO 23908:2025 standard is designed for a wide range of stakeholders in the healthcare industry, including:

  • Healthcare facilities and hospitals
  • Medical device manufacturers
  • Safety officers and compliance managers
  • Regulatory bodies and inspectors

Each of these groups can benefit from the comprehensive guidelines provided by the standard, ensuring that their operations are safe, efficient, and compliant with international best practices.

Conclusion

The BS EN ISO 23908:2025 standard is an indispensable resource for anyone involved in the healthcare industry. By providing clear and detailed guidelines for sharps protection mechanisms, it plays a crucial role in enhancing safety and compliance. Whether you are a healthcare provider, a medical device manufacturer, or a safety officer, this standard will help you achieve the highest levels of safety and efficiency in your operations.

Invest in the safety of your staff and patients by implementing the BS EN ISO 23908:2025 standard today. Ensure that your facility is at the forefront of safety and compliance in the healthcare industry.

DESCRIPTION

BS EN ISO 23908:2025


This standard BS EN ISO 23908:2025 Sharps injury protection. Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration. Requirements and test methods is classified in these ICS categories:
  • 11.040.99 Other medical equipment
  • 11.040.25 Syringes, needles and catheters
This document provides requirements and test methods to evaluate the performance and usability of sharps injury protection mechanisms (SIPMs) of devices including a single use sharp, for administration and/or extraction of blood or body fluids and/or medicinal substances. The sharps injury protection mechanisms covered by this document can be provided integral to the device or for assembly with the device prior to use. The aim of the tests is to confirm minimization of risks of accidental sharps injury from contaminated sharps, after the period of intended use, including the path to safe disposal or recovery, where this is a legal requirement or the manufacturers’ decision. This document does not cover —     devices for medication loading and transfer, utilizing a blunt tip design, or —     invasive products whose intended use is to access small spaces, particularly ear, nose and throat, to perform ophthalmic procedures because their SIPMs have been found to adversely affect the usability and can increase the risk for patients versus the benefit of the intended use of the device. This document does not cover solid-core needles used for surgery (e.g. suture needles).