Health Care Technology Official British Standard

BS EN ISO 15883-6:2015

Ensure compliance with BS EN ISO 15883-6:2015 for effective disinfection of non-invasive medical devices, enhancing patient safety and operational efficiency.

Overview

BS EN ISO 15883-6:2015 specifies the requirements and testing methods for washer-disinfectors that employ thermal disinfection processes for non-invasive, non-critical medical devices and healthcare equipment. This standard is essential for ensuring that such devices are effectively cleaned and disinfected, thereby minimising the risk of infection in healthcare settings.

Key Requirements

The standard outlines critical requirements that washer-disinfectors must meet to ensure efficacy and safety. These include:

  • Performance Testing: Washer-disinfectors must undergo rigorous testing to verify their disinfection capabilities, including thermal disinfection efficacy.
  • Design Specifications: The design must facilitate effective cleaning and disinfection, including appropriate water flow and temperature control.
  • Validation Protocols: Procedures for validating the performance of washer-disinfectors must be established, ensuring compliance with the standard.
  • Maintenance Guidelines: Clear guidelines for routine maintenance and servicing must be provided to ensure ongoing compliance and performance.

Implementation Benefits

Adopting BS EN ISO 15883-6:2015 offers numerous benefits for healthcare facilities:

  • Enhanced Patient Safety: By ensuring that non-critical medical devices are properly disinfected, the risk of healthcare-associated infections is significantly reduced.
  • Regulatory Compliance: Compliance with this standard helps healthcare providers meet legal and regulatory requirements, thereby avoiding potential penalties.
  • Operational Efficiency: Implementing standardised processes for cleaning and disinfection can streamline operations, reduce downtime, and improve resource management.
  • Quality Assurance: Regular testing and validation of washer-disinfectors ensure consistent performance, enhancing the overall quality of healthcare services.

Compliance Value

Compliance with BS EN ISO 15883-6:2015 not only demonstrates a commitment to high standards of hygiene and safety but also provides a competitive advantage in the healthcare sector. Facilities that adhere to this standard can confidently assure patients and regulatory bodies of their dedication to infection control. Furthermore, compliance can facilitate smoother audits and inspections, reinforcing the facility's reputation for quality care.

In conclusion, BS EN ISO 15883-6:2015 is a vital standard for healthcare technology, particularly for the effective disinfection of non-invasive, non-critical medical devices. By implementing the requirements outlined in this standard, healthcare facilities can enhance patient safety, ensure regulatory compliance, and improve operational efficiency.

Technical Information

Health Care Technology
BSI Group
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Specification Details
  • Washer-disinfectors - Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
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