Medical devices are a broad group of products with different characteristics. Thus, many standards have been developed to establish general and particular specifications for them. In this text, we cover the most relevant international standards that can be found in the medical device industry that are useful for regulatory purposes.
ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes
Based on principles of ISO 9000 and 9001 for general Quality Management Systems (QMS), the standard ISO 13485 covers the specifications and requirements to provide medical devices that consistently meet customer needs and applicable regulatory requirements in all stages of the life cycle, including design and development, production, storage, distribution, installation, or servicing.
ISO 14971 Medical devices — Application of risk management to medical devices
A standard based on ISO 31000 for general risk management. This ISO includes definitions, principles and internationally recognized methods to reduce risks for all stakeholders, including of course medical device manufacturers. It is useful to identify the hazards associated with the product and to estimate, evaluate, control and monitor the related risks.
ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation, and routine control of a sterilization process for medical devices
This standard is primarily used in the industry as several medical devices are sterilized with EO (Ethylene Oxide). This standard specifies requirements for development, validation, and routine control of EO sterilization process for medical devices.
ISO 11607 Packaging for terminally sterilized medical devices
Part 1: Requirements for materials, sterile barrier systems and packaging system
Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11137 Sterilization of health care products — Radiation
Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Part 2: Establishing the sterilization dose
ISO 15223 Medical devices — Symbols to be used with information to be supplied by the manufacturer
Part 1: General requirements
Part 2: Symbol development, selection and validation
Specifies symbols used to express information supplied for a medical device used in a broad spectrum of products. These symbols can be used on the medical device itself, the product label, on its packaging or in the accompanying information (Instructions for Use or Manuals).
ISO 20417 -Medical devices — Information to be supplied by the manufacturer
This standard specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory and tends to be consistent across different product categories in all geographical locations. This is a brand-new standard that was released in 2021.
ISO 10993 Biological evaluation of medical devices
This is one of the largest standards consisting of 23 parts, and it becomes applicable when the product comes into contact with the patient or user. This ISO specifies the general principles of the biological evaluation of medical devices within a risk management process.
IEC 60601 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance
This standard is applicable to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The more common tests reports for Electrical Safety and Electromagnetic Compatibility (EMC) can be found at IEC 60601-1 and IEC 60601-1-2, respectively.
We have mentioned some of the most relevant standards related to Medical Devices.
It is worth to mentioning that more than 100 standards are related to medical devices, its components or raw materials including international ISO, IEC, IEEE, ANSI, ASTM or local standards such as NOM, INMETRO, UL, among others. If your have additional questions regarding the applicable standards for your medical devices for regulatory compliance, please contact us at firstname.lastname@example.org.