What is IEC 60268-17:2021 ?

IEC 60268-17:2021 is an essential standard for nerve and muscle stimulators used in healthcare settings. This international standard aims to establish a common language for manufacturers and users to ensure the safety and effectiveness of these devices. IEC 60268-17:2021 covers various aspects of the stimulator, including its design, performance, and testing.

The scope of IEC 60268-17:2021 is extensive, as it aims to provide a comprehensive standard for medical electrical equipment and systems. It covers the entire lifecycle of the stimulator, from its design and manufacture to its performance and maintenance. The standard is divided into ten parts, each covering a specific aspect of the stimulator's design and performance.

Key Requirements

The key requirements of IEC 60268-17:2021 are designed to ensure the safety and effectiveness of the stimulator. These requirements are divided into four categories: essential safety requirements, essential performance requirements, essential tests, and essential documentation.

Essential Safety Requirements

The essential safety requirements of IEC 60268-17:2021 are intended to ensure the safety of the users, patients, and others who may be in contact with the stimulator. These requirements include requirements for the design, materials, and testing of the stimulator. The standard specifies the maximum allowable voltage, current, and power levels, as well as the requirements for the stimulator's dimensions and weight.

Essential Performance Requirements

The essential performance requirements of IEC 60268-17:2021 are intended to ensure the performance of the stimulator in terms of its intended functions. These requirements include requirements for the stimulator's output current, voltage, and frequency, as well as the requirements for the stimulator's power consumption and performance under various operating conditions.

Essential Tests

The essential tests of IEC 60268-17:2021 are intended to ensure that the stimulator meets the requirements for essential safety and performance. These tests include requirements for the stimulator's environmental conditions, such as temperature, humidity, and vibration, as well as requirements for the stimulator's performance under various operating conditions, such as high and low voltage.

Essential Documentation

The essential documentation requirements of IEC 60268-17:2021 are intended to ensure that the stimulator is properly documented and can be used effectively by users and manufacturers. These requirements include requirements for the stimulator's user manual, maintenance manual, and testing documentation.

Conclusion

IEC 60268-17:2021 is an essential standard for nerve and muscle stimulators used in healthcare settings. It provides a comprehensive guide for manufacturers and users to ensure the safety and effectiveness of these devices. By understanding the key requirements of this standard, manufacturers can ensure that their stimulators meet the necessary safety and performance standards, while users can be confident in the safety and effectiveness of the stimulator..