A neonatal incubator is a rigid box-like enclosure in which an infant can be kept in a controlled environment for observation and care. The device may include a heater, a fan, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care. Infant Incubator…
What is IEC 60601-1? Standards are an integral part of product design and development, and are certainly important in medical applications. IEC 60601 is a series of technical standards applies to Medical Electrical Equipment & Medical Electrical System for Basic Safety & Essential Performance. The basic scope of IEC 60601-1 is safety of patient, user and…
What is Medical Electrical Equipment? Medical Electrical Equipment is defined in the standard as electrical equipment having an applied part or transferring energy to or from the patient or detecting such energy transfer to or from the patient and which is: Provided with not more than one connection to a particular supply mains; and Intended…
Applied Parts are part of Medical Electrical Devices & Equipment which comes in direct or indirect contact with patient to perform its function. These part are classified into B, BF, CF Applied Parts. Type CF Applied Parts are also known as Defibrillation Proof Applied Parts. This is second classification for protection against electric shock. CF…
Protection against patient entrapment in non moving parts IEC 60601-2-52 Types of injuries caused due to entrapment in Medical beds … To save the patient from injuries that may be caused due entrapment in non moving parts of medical bed, international standards are being made. Testing is mandatory for all hospital medical beds both…
Safe Working Load Test on Medical Beds As Per IEC 60601-2-52 All the medical beds and bed lifts must be marked with the maximum patient weight and the safe working load of the bed. The safe working load test is performed for patient safety, while serving for support or immobilization of the patient, risk of…
The basic scope of IEC 60601-1 is safety of patient, user and the equipment. Before launch of the Medical equipment in the market , It must be be tested as per the safety standard. All the accessories used with the equipment must be tested as per Particular standard IEC 60601-2-X series. It is also a…
Standards play a paramount role in product design and development. IEC 60601-1 is a series of technical standards for the safety and effectiveness of medical electrical equipment. The force of this standard is to require two level of protection to guard the patient and operator from any injury. It is recognized worldwide. This standard is…
