What is SASO IEC 60601-2-20:2020?

SASO IEC 60601-2-20:2020 is a technical standard developed by the Saudi Arabian Standards Organization (SASO) in collaboration with the International Electrotechnical Commission (IEC). It provides specific requirements for the safety and essential performance of infant incubators used in healthcare settings. This standard ensures that these medical devices meet the necessary safety criteria to protect both infants and healthcare providers.

1. Safety Requirements

The main objective of SASO IEC 60601-2-20:2020 is to establish rigorous safety requirements for infant incubators. These safety requirements cover various aspects such as electrical safety, mechanical safety, temperature control, alarms, and emergency stop functions. The standard specifies methods for testing and evaluating the performance of these devices to ensure that they comply with the defined safety levels.

2. Essential Performance

In addition to safety, the standard also addresses the essential performance of infant incubators. These performance requirements focus on maintaining a stable and controlled environment for newborns, including parameters like temperature, humidity, oxygen concentration, and noise level. By setting these standards, the aim is to provide optimal conditions for the growth and development of infants requiring special care.

3. Compliance and Certification

To ensure compliance with SASO IEC 60601-2-20:2020, manufacturers of infant incubators need to perform comprehensive testing and evaluation. They must demonstrate that their products meet all the safety and performance requirements outlined in the standard. Once compliance is achieved, the manufacturer can obtain the necessary certifications, which are required for marketing and selling their devices in Saudi Arabia and other countries adhering to similar regulations.

SASO IEC 60601-2-20:2020 plays a crucial role in safeguarding the well-being of infants in healthcare settings. By defining stringent safety and performance requirements, the standard ensures that infant incubators meet the highest levels of quality and reliability. It is an essential tool for manufacturers, healthcare professionals, regulatory bodies, and anyone involved in the design, production, or use of these critical medical devices.