Health Care Technology
Official British Standard
BS EN IEC 60601-2-39:2019
Comprehensive healthcare technology standard BS EN IEC 60601-2-39:2019. Ensures safety and performance of peritoneal dialysis equipment. Complies with EN 60335-2-25 and IEC 60601-2-39.
# BS EN IEC 60601-2-39:2019 - Peritoneal Dialysis Equipment Safety Standard## OverviewBS EN IEC 60601-2-39:2019 is the essential healthcare technology standard for ensuring the safety and performance of peritoneal dialysis equipment. This British Standard is identical to the European (EN) and International (IEC) standards, providing a comprehensive set of requirements for the design, manufacture, and testing of peritoneal dialysis machines and related accessories.## Key Specifications- Identical to EN 60335-2-25:2002/A11:2010, EN IEC 60601-2-39:2019, and IEC 60601-2-39:2018- Covers safety and essential performance requirements for peritoneal dialysis equipment- Applies to home-use and professional-use peritoneal dialysis machines- Includes requirements for mechanical, electrical, and software safety- Specifies testing methods for evaluating compliance with the standard## Benefits of Compliance- Ensures the safety of patients and operators using peritoneal dialysis equipment- Mitigates risks of electrical shock, mechanical injury, software malfunctions, and other hazards- Enables peritoneal dialysis equipment to be safely used in both home and clinical settings- Supports regulatory approval and market access for peritoneal dialysis products- Demonstrates adherence to the latest international safety standards for healthcare technology## ConclusionBS EN IEC 60601-2-39:2019 is an essential standard for any manufacturer, designer, or supplier of peritoneal dialysis equipment. By complying with this comprehensive standard, you can ensure the safety and performance of your products, meeting the rigorous requirements for healthcare technology used in both home and professional environments. Invest in this standard to demonstrate your commitment to patient safety and regulatory compliance.
Technical Information
Health Care Technology
BSI Group
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Specification Details
- Medical electrical equipment - Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
Official BSI Standard
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