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Medical Devices Standards

March 24, 2022 - Parul Saini, Webmedy Team


Medical devices must comply with strict general controls and procedural guidelines. To ensure the safety and efficacy of medical devices, standards must be developed and used. Several regulatory agencies and standards organizations collaborate in the development of accepted standards for medical equipment. The development of performance characteristics, characterization and testing methods, manufacturing practices, product standards, scientific protocols, compliance criteria, ingredient specifications, labeling, and other technical or policy criteria constitute standard-setting activities.

Medical devices are used to diagnose and treat illnesses, improve health, and improve the quality of life for patients. Implants and imaging equipment are among the products used in medical care. Every year, the top players in the medical device industry bring in billions of dollars. As medical devices are crucial tools for healthcare, and as these devices can have direct impacts on public health and quality of life, their safety is imperative. Companies must follow relevant medical device manufacturing standards to create desirable outcomes for all parties and prevent device recalls. To serve patients and healthcare professionals effectively, these standards ensure that manufacturing or design processes will produce consistently high quality.

Major International Medical Device Standards

Compliance with international standards provides a chance for medical device producers to reach the global market. The name of the standard is usually represented by a combination of a few integers and a few numbers. The letters at the start of a standard are an abbreviation for the issuing organization, the numbers before the colon are the standard's number assigned by its developers, and the digits after the colon are the year of its issue.

Two associations commonly issue worldwide norms: the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

  • ISO Standards

    In the medical device industry, ISO 13485:2016 is the main standard for Quality Management Systems (QMS) designed to ensure that medical devices are designed, manufactured, delivered, and disposed of properly.

    ISO 9001:2015 is the standard for quality management used by medical devices manufacturers to ensure the quality of their products.

    ISO 27799:2016 sets requirements for medical device makers regarding the confidentiality and security of the personal health information of their patients.

    According to ISO 14001:2015, medical device companies must establish an environmental management system that reduces waste and conserves energy.

    Medical device manufacturers implementing ISO 50001:2018 can establish an energy management system that enables them to continuously improve energy efficiency.

    A guide to risk management of medical devices, software as a medical device, and in vitro diagnostic medical devices is described in ISO 14971:2019.

    As part of ISO 45001:2018, health and safety management systems that can be used in the medical device industry are defined so that occupational accidents and associated liability issues can be reduced.

    ISO 15223-1:2016 specifies symbols to be used for the labeling of medical devices and for accompanying documentation as well as for packages that contain medical devices.

    As part of ISO 16142-2:2017, the essential principles of safety and performance of medical devices are listed and defined, standards and guidelines that may be used in assessing a medical device's compliance with these principles are identified.

    The ISO 18113-1 standard provides general principles and essential requirements for information required by manufacturers of in vitro diagnostic medical devices.

  • IEC Standards

    According to IEC 62304:2006, a medical device software's lifecycle is specified.

    According to IEC 62366-1:2015, medical device usability is the process of analyzing, specifying, developing, and evaluating medical devices. Additionally, it describes how to assess and mitigate risks during the correct use of the device.

    With IEC 82304-1:2016, manufacturers are provided with guidance regarding the safety and security of health software products without dedicated hardware.

As a medical device manufacturer, ISO compliance helps prove the high quality and safety of its products as well as manufacturers' concern for the environment and consumer interests.

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