المقالات >

medical devices range from simple heating blankets, electrical hospital beds, or electronic fever thermometers, to complex programmable electronic equipment such as Magnetic Resonance Imaging (MRI), medical lasers, incubators, cardiac monitors, and other life-support devices

All of them need to meet a rather complicated set of safety requirements. Compliance regulations heavily affect their design and manufacture, including mechanical, electrical, and software matters

Standards, regulations, and verification are closely linked. Standardized technologies that are tested and certified for safety, quality, and performance contribute to overall risk management. They also help improve processes and the understanding of device interactions

In the regulatory world, standards are essentially recommended processes that have been developed by subject matter experts with the aim of describing the best possible way to meet an end goal. For example, quality management standards are designed to improve efficiencies and avoid product failures

Similarly, risk management standards are designed to help organizations plan for the unexpected and ensure operational continuity. These are just two common examples of the many application standards for medical device manufacturers

  The International Organization for Standardization (ISO) sets global standards for quality and risk management for a broad range of products and businesses. Likewise, the International Electrotechnical Commission (IEC) sets international standards for all electrical, electronic, and related technologies. In general, ISO concentrates on controls for materials and processes, and IEC concentrates on the manufacturing and testing of products

Figure. 1 – Typical process for standards development

Some Of The Most Common Reference Standards For Medical Devices

ISO 13485, Is the standard for medical device quality management systems. ISO 13485:2016 is the most current version

ISO 14971, Is the standard for medical device risk management. The most current version is ISO 14971:2019

ISO 9001, is the standard for business quality management systems, and the most current version is ISO 9001:2015

ISO 62304 is the standard for software used in medical devices, and ISO 62304:2006 is the most current version

ISO 10993, which has 23 parts, is the standard for the biological evaluation of medical devices

ISO 15223, which has two parts, is the standard for symbols to be used with medical device labels, labeling, and information to be supplied

ISO 11135 is the standard for ethylene oxide sterilization of medical devices, and ISO 11135:2014 is the most current version

ISO 11137, is the standard for sterilization of medical devices using radiation

ISO 11607 is the standard for sterilized product packaging for medical devices

IEC 60601, which is published by the IEC. This standard applies to the safety and essential performance of medical electrical equipment. Every country has a different version, and devices must comply with the standards that apply in each market