BS EN IEC 60601-2-39:2019 - Medical Electrical Equipment Standard

In the ever-evolving world of medical technology, ensuring the safety and performance of medical equipment is paramount. The BS EN IEC 60601-2-39:2019 standard is a crucial document that sets out the particular requirements for the basic safety and essential performance of peritoneal dialysis equipment. Released on August 14, 2019, this standard is an indispensable resource for manufacturers, healthcare providers, and regulatory bodies involved in the design, production, and use of peritoneal dialysis equipment.

Overview of the Standard

The BS EN IEC 60601-2-39:2019 standard is part of the IEC 60601 series, which is internationally recognized for its comprehensive guidelines on the safety and performance of medical electrical equipment. This particular standard focuses on peritoneal dialysis equipment, which is used in the treatment of patients with kidney failure. The document outlines specific requirements that ensure the equipment is safe for use and performs effectively, thereby safeguarding patient health and well-being.

Key Features and Benefits

• Comprehensive Safety Guidelines: The standard provides detailed safety requirements that manufacturers must adhere to, ensuring that peritoneal dialysis equipment is safe for both patients and healthcare professionals.
• Performance Standards: It sets out essential performance criteria that the equipment must meet, ensuring reliable and effective treatment for patients undergoing peritoneal dialysis.
• International Recognition: As part of the IEC 60601 series, this standard is recognized globally, facilitating international trade and compliance with regulatory requirements across different countries.
• Updated Information: Released in 2019, the standard incorporates the latest advancements and research in medical technology, providing up-to-date guidelines for the industry.

Technical Details

The BS EN IEC 60601-2-39:2019 standard is a comprehensive document consisting of 34 pages. It is identified by the ISBN number 978 0 580 90148 5. As a standard, it holds a current status, meaning it is actively used and referenced in the medical equipment industry.

Importance for Manufacturers and Healthcare Providers

For manufacturers, adhering to the BS EN IEC 60601-2-39:2019 standard is crucial for ensuring that their peritoneal dialysis equipment meets the necessary safety and performance requirements. Compliance with this standard not only enhances the credibility of the manufacturer but also ensures that their products are accepted in international markets.

Healthcare providers benefit from this standard by having access to equipment that is designed and tested to meet rigorous safety and performance criteria. This ensures that patients receive the highest quality of care, reducing the risk of complications and improving treatment outcomes.

Conclusion

The BS EN IEC 60601-2-39:2019 standard is an essential document for anyone involved in the design, manufacture, or use of peritoneal dialysis equipment. By providing clear guidelines on safety and performance, it plays a vital role in ensuring the well-being of patients and the effectiveness of medical treatments. Whether you are a manufacturer looking to ensure compliance or a healthcare provider seeking reliable equipment, this standard is an invaluable resource that supports the delivery of safe and effective healthcare solutions.

BS EN IEC 60601-2-39:2019

This standard BS EN IEC 60601-2-39:2019 Medical electrical equipment is classified in these ICS categories:

• 11.040.99 Other medical equipment

IEC 60601-2-39:2018 is also available as IEC 60601-2-39:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 60601-2-39:2018 applies to the basic safety and essential performance of peritoneal dialysis medical electrical equipment. It applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equipment operated by the patient, regardless of whether the peritoneal dialysis equipment is used in a hospital or domestic environment. This third edition cancels and replaces the second edition of IEC 60601-2-39. It constitutes a technical revision.This edition includes the following significant technical changes with respect to the previous edition:
- update of the references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012 and of references and requirements to IEC 60601-1-11:2015;
- editorial improvements;
- improvement of the essential performance requirements clause/subclauses;
- new requirements for the interruption of the power supply.