BS EN IEC 60601-2-39:2025 - Medical Electrical Equipment Standard

Introducing the BS EN IEC 60601-2-39:2025, a comprehensive standard that sets forth the particular requirements for the basic safety and essential performance of peritoneal dialysis equipment. This standard is an essential resource for manufacturers, healthcare professionals, and regulatory bodies involved in the design, production, and use of medical electrical equipment, specifically tailored for peritoneal dialysis.

Overview

The BS EN IEC 60601-2-39:2025 standard is a critical document that ensures the safety and performance of peritoneal dialysis equipment. Released on February 14, 2025, this standard is part of the globally recognized IEC 60601 series, which is dedicated to the safety and performance of medical electrical equipment. With a total of 62 pages, this document provides detailed guidelines and requirements that must be adhered to in order to ensure the highest level of safety and efficacy in peritoneal dialysis equipment.

Key Features

• Standard Number: BS EN IEC 60601-2-39:2025
• Release Date: February 14, 2025
• ISBN: 978 0 539 16776 4
• Status: Standard
• Pages: 62

Importance of Compliance

Compliance with the BS EN IEC 60601-2-39:2025 standard is crucial for manufacturers and healthcare providers. It ensures that peritoneal dialysis equipment meets the necessary safety and performance criteria, thereby minimizing risks to patients and healthcare professionals. Adhering to this standard not only enhances the reliability and effectiveness of the equipment but also aligns with international safety regulations, facilitating smoother market access and acceptance.

Who Should Use This Standard?

This standard is indispensable for a wide range of stakeholders in the healthcare and medical device industry, including:

• Manufacturers: To design and produce peritoneal dialysis equipment that meets international safety and performance standards.
• Regulatory Bodies: To ensure that the equipment complies with the necessary safety regulations before it reaches the market.
• Healthcare Providers: To understand the safety and performance requirements of the equipment they use, ensuring optimal patient care.
• Quality Assurance Professionals: To implement and maintain compliance with the standard, ensuring continuous improvement in product safety and performance.

Benefits of the Standard

The BS EN IEC 60601-2-39:2025 standard offers numerous benefits, including:

• Enhanced Safety: By providing clear guidelines for safety, the standard helps reduce the risk of harm to patients and healthcare workers.
• Improved Performance: Ensures that peritoneal dialysis equipment operates effectively and reliably, leading to better patient outcomes.
• Global Recognition: As part of the IEC 60601 series, this standard is recognized worldwide, facilitating international trade and market access.
• Regulatory Compliance: Helps manufacturers meet regulatory requirements, reducing the risk of non-compliance penalties.

Conclusion

The BS EN IEC 60601-2-39:2025 is an essential standard for anyone involved in the design, production, regulation, or use of peritoneal dialysis equipment. By adhering to this standard, stakeholders can ensure that their equipment meets the highest safety and performance standards, ultimately leading to improved patient care and safety. Whether you are a manufacturer, healthcare provider, or regulatory body, this standard is a vital resource for ensuring the quality and reliability of peritoneal dialysis equipment.

BS EN IEC 60601-2-39:2025

This standard BS EN IEC 60601-2-39:2025 Medical electrical equipment is classified in these ICS categories:

• 11.040.99 Other medical equipment

IEC 60601-2-39:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT, hereafter referred to as PD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of whether the PD EQUIPMENT is used in a hospital or domestic environment. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. This document does not take into consideration specific safety details of the DIALYSING SOLUTION control system of PD EQUIPMENT using regeneration of DIALYSING SOLUTION or CENTRAL DELIVERY SYSTEMS for DIALYSING SOLUTION. It does, however, take into consideration the specific safety requirements of such PD EQUIPMENT concerning electrical safety and PATIENT safety. This document specifies the minimum safety requirements for PD EQUIPMENT. These PD EQUIPMENT are intended for use either by medical staff or for use by the PATIENT or other trained personnel under medical supervision. This document includes all ME EQUIPMENT that is intended to deliver a PERITONEAL DIALYSIS treatment to a PATIENT, independent of the treatment duration and location. These particular requirements do not apply to: – PRE-MANUFACTURED DIALYSING SOLUTION bags, – DIALYSING SOLUTION CIRCUITS, – DIALYSING SOLUTION CONCENTRATE, – DIALYSIS WATER supply systems (see ISO 23500-2) , – CENTRAL DELIVERY SYSTEMS for DIALYSING SOLUTION CONCENTRATES, described as systems for bulk mixing concentrate at a dialysis facility, – equipment used to perform HAEMODIALYSIS (see IEC 60601-2-16). IEC 60601-2-39:2024 cancels and replaces the third edition published in 2018. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) update of references to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601 1:2005/AMD2:2020, of references to IEC 60601 1 2:2014 and IEC 60601 1 2:2014/AMD1:2020, of references to IEC 60601-1-8:2006, IEC 60601 1 8:2006/AMD1:2012 and IEC 60601 1 8:2006/AMD2:2020, of references to IEC 60601 1 9:2007, IEC 60601 1 9:2007/AMD1:2013 and IEC 60601 1 9:2007/AMD2:2020, of references to IEC 60601 1 10:2007, IEC 60601 1 10:2007/AMD1:2013 and IEC 60601 1 10:2007/AMD2:2020 and of references to IEC 60601 1 11:2015 and IEC 60601 1 11:2015/AMD1:2020; b) consideration of ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION regarding IEC 60601 1:2005/AMD1:2012/ISH1:2021; c) including the information given in the document 62D/1771A/INF regarding 201.11.8; d) including the information given in the document 62D/1734/INF regarding technical issues of the previous edition; e) including SECURITY (CYBERSECURITY) requirements; f) additions related to online PD SOLUTION generation (ONLINE PD); g) improvements regarding the definition of the APPLIED PART; h) improvement of the essential performance requirements clause/subclauses; i) improvements for labelling; j) other minor technical improvements; k) editorial improvements.