ISO Medical Device Standards

Medical devices are powerful and essential tools in the healthcare industry. Because they come in direct contact with patients and can have an effect on them, ensuring they meet safety standards is a critical part of the development and manufacturing processes.

Regulatory bodies create standards for all aspects of medical device development. Agencies like the Food & Drug Administration (FDA) govern medical devices within the United States with medical device regulation, and FDA requirements often match or overlap with international standards. If you are developing a medical device in the United States, achieving additional safety certifications from trusted sources is key to entering the global market and showing customers that you are committed to producing quality healthcare products.

Navigating international safety regulations and obtaining the right certifications for your medical device can be complicated. But you don’t have to worry—in2being is here to help every step of the way.

What Are ISO Medical Device Standards?

The International Organization for Standardization (ISO) is an independent organization dedicated to publishing quality and risk management standards for product development in a variety of industries, including medical devices.

ISO medical device standards are intended to help designers and manufacturers create products that are safer, more effective, and in line with user needs.

ISO Standards for Medical Devices

There are several ISO standards for medical devices. The most commonly applied standards are 14971, 10993, 62304, and 13485.

If you are unsure of how these standards relate to your medical device or if you have questions about how to meet these regulations, find a consultant with experience in medical device standards. At in2being, we have experience in helping medical device manufacturers achieve ISO safety certifications, and we’re ready to answer your questions.

ISO 14971: Risk Management

ISO 14971 is a safety standard governing risk management in the medical device development process that is used worldwide. Medical device companies must have risk management processes that comply with ISO 14971 if they want to sell their product internationally.

For most medical devices, there are inherent hazards that lead to a certain level of risk associated with normal use of the device. The purpose of ISO 14971 is to develop an effective risk management strategy in response to that level of risk.

There are three general parts of a risk management strategy, as outlined by ISO 14971, that medical device manufacturers must have the ability to:

• Identify sources of risk at all stages of the product lifecycle
• Quantify and evaluate that risk
• Create and implement risk control measures

We all want our medical devices to be safe and risk-free. ISO 14971 helps developers meet those expectations.

ISO 10993: Biocompatibility

ISO 10993 involves the biocompatibility of medical devices. Because these products often come into direct contact with patients, developers have a responsibility to protect patients and healthcare workers from biological risks. A harmful interaction between a medical device and the cells, tissues, or bodily fluids of a patient could lead to adverse short-term or long-term effects that must be avoided at all costs.

To ensure patient safety, ISO 10993 provides a framework for testing the biocompatibility of medical devices. Developers are required to biologically evaluate their medical devices, but the specifics of which tests to include is based on several factors:

• The type of medical device
• The material of the medical device
• The intended use of the medical device
• The nature and duration of contact between the medical device and the patient

Depending on these factors, biocompatibility tests under ISO 10993 could include cytotoxicity, sensitization, hemocompatibility, and others. The latest revision of ISO 10993 also includes the requirement for a Biological Risk Assessment, which is both a powerful tool as well as a challenging step for those unfamiliar with it.

IEC 62304: Medical Device Software

IEC 62304 applies to medical device software. Regulatory bodies around the world, including the FDA, use this standard to ensure the safe design, development, production, and maintenance of software used in medical devices.

Software that falls under the category of medical device software includes the following:

• Software that is itself a medical device, commonly known as SaMD (Software as a Medical Device)
• Software that is used in the production of the medical device
• Software that is embedded in or a component of the final medical device

Manufacturers can use the guidelines outlined in IEC 62304 to identify hazards that could result from software failure, create safety-related processes throughout the software lifecycle, and provide customers with an approach to maintaining and surveilling the software.

Different types of medical device software have different risks and safety standards. This regulation helps manufacturers prepare for and avoid those risks as well as meet and exceed safety standards.

What Is the Purpose of ISO Certifications for Medical Devices?

Before medical devices developed in the United States can be marketed globally, manufacturers must obtain certain ISO certifications. These certifications can also build credibility with customers, showing them that the medical device meets international quality, risk management, and safety standards.

While it takes time, money, and effort to meet ISO medical device standards, the advantages are evident. Both developers and customers benefit from achieving ISO certifications.

Are you ready to get started? We’re ready to help.

in2being Can Help Your Company Meet ISO Medical Device Standards

At in2being, we have experience in helping businesses and individuals navigate medical device development from start to finish. We can guide you through the ISO certification process and give you practical advice and suggestions for improvement beyond compliance with basic regulations. With our holistic approach, the professionals at in2being are ready to help. Contact us today to learn more.