BS EN ISO 16571:2024 - Systems for Evacuation of Plume Generated by Medical Devices

Standard Number: BS EN ISO 16571:2024

Pages: 46

Released: 2024-05-16

ISBN: 978 0 539 19477 7

Status: Standard

Overview

The BS EN ISO 16571:2024 standard is an essential document for healthcare facilities and medical device manufacturers. It provides comprehensive guidelines for the design, implementation, and maintenance of systems used to evacuate plumes generated by medical devices. These plumes, often produced during surgical procedures, can contain harmful substances that pose risks to both patients and healthcare professionals. This standard ensures that the evacuation systems are effective, reliable, and safe.

Key Features

• Comprehensive Guidelines: The standard offers detailed instructions on the design and implementation of plume evacuation systems, ensuring they meet the highest safety and efficiency standards.
• Safety First: By adhering to this standard, healthcare facilities can significantly reduce the risk of exposure to harmful substances for both patients and staff.
• Up-to-Date Information: Released on May 16, 2024, this standard incorporates the latest research and technological advancements in the field.
• Global Relevance: As an ISO standard, it is recognized and applicable worldwide, making it a valuable resource for international healthcare providers and medical device manufacturers.

Why You Need This Standard

In the fast-evolving field of medical technology, staying updated with the latest standards is crucial. The BS EN ISO 16571:2024 standard is designed to help healthcare facilities and medical device manufacturers ensure the highest levels of safety and efficiency in their operations. By implementing the guidelines provided in this standard, you can:

• Enhance Patient Safety: Proper evacuation of plumes reduces the risk of infection and exposure to harmful substances.
• Protect Healthcare Workers: Minimize the risk of occupational hazards associated with plume exposure.
• Ensure Compliance: Meet regulatory requirements and industry best practices, avoiding potential legal and financial repercussions.
• Improve Operational Efficiency: Well-designed evacuation systems can streamline surgical procedures and improve overall workflow.

Detailed Content

The BS EN ISO 16571:2024 standard spans 46 pages, offering in-depth coverage of various aspects related to plume evacuation systems. Some of the key topics covered include:

• Design Specifications: Detailed guidelines on the design of evacuation systems, including material selection, system layout, and integration with existing medical devices.
• Installation Procedures: Step-by-step instructions for the proper installation of evacuation systems to ensure optimal performance.
• Maintenance and Testing: Recommendations for regular maintenance and testing to ensure the systems remain effective and reliable over time.
• Safety Protocols: Comprehensive safety protocols to protect both patients and healthcare workers from potential hazards associated with plume exposure.
• Compliance and Certification: Information on how to achieve compliance with the standard and obtain necessary certifications.

Who Should Use This Standard?

The BS EN ISO 16571:2024 standard is a valuable resource for a wide range of professionals and organizations, including:

• Healthcare Facilities: Hospitals, clinics, and other healthcare providers can use this standard to ensure their plume evacuation systems are safe and effective.
• Medical Device Manufacturers: Companies that design and produce medical devices can use the guidelines in this standard to develop products that meet the highest safety and performance standards.
• Regulatory Bodies: Organizations responsible for setting and enforcing healthcare standards can use this document as a reference for evaluating compliance.
• Safety Officers: Professionals responsible for workplace safety in healthcare settings can use this standard to develop and implement effective safety protocols.

Conclusion

The BS EN ISO 16571:2024 standard is an indispensable tool for anyone involved in the design, implementation, and maintenance of plume evacuation systems in healthcare settings. By following the comprehensive guidelines provided in this standard, you can ensure the highest levels of safety and efficiency, protecting both patients and healthcare workers from potential hazards. Stay ahead of the curve and make sure your facility or product meets the latest industry standards with the BS EN ISO 16571:2024.

BS EN ISO 16571:2024

This standard BS EN ISO 16571:2024 Systems for evacuation of plume generated by medical devices is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment

This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.  This document applies to all types of plume evacuation systems (PESs), including a)       portable; b)       mobile; c)        stationary, including dedicated central pipelines; d)       PESs integrated into other equipment; e)       PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic) This document applies to all healthcare facilities where PESs are used, including, but not limited to a)       surgical facilities; b)       medical offices; c)        cosmetic treatment facilities; d)       medical teaching facilities; e)       dental clinics; f)         veterinary facilities. This document provides guidance on the following aspects of PESs: a)       importance; b)       purchasing; c)        design; d)       manufacture; e)       documentation; f)         function; g)       performance; h)       installation; i)         commissioning; j)         testing; k)       training; l)         use; m)     risk assessment; n)       servicing; o)       maintenance. This document does not apply to the following: a)       anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2; b)       medical vacuum systems which are covered in ISO 7396-1; c)        heating, ventilation, and air-conditioning (HVAC) systems; d)       aspects of laser safety other than airborne contamination; and e)       aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.