Medical devices

ISO 13485:2016 Sterilization Processes

Medical devices, in the absence of sterilization, pose many different health risks that simply can’t be tolerated.

Sterilizing medical devices is of vital significance in the medical sector. Even so, at various places in the world, surgical devices are not properly sterilized. As a result, many patients die, while many more are diagnosed with various infections after surgery, and other complications also arise due to a lack of proper sterilization.

Sterilization is a process that is mandatory for the majority of, medical devices, quite often required by regulatory authorities. It is a process to make the product free from bacteria and any other microorganism that cannot be eliminated by regular cleaning processes. Therefore, sterilization requirements have been addressed separately in ISO 13485:2016. Surgical instruments are often reused, but after surgery they are contaminated by microorganisms. So, in order to reuse such medical devices after surgery, effective sterilization is necessary. There are various methods of sterilization available, which include autoclaving, radiation, ethylene oxide (EtO) sterilization, chlorine dioxide sterilization, hydrogen peroxide sterilization, and others.

For manufacturers performing sterilization and hospital service providers, GMED offers QMS certification completed by the following standards:

This certification provides customers and competent authorities with quality assurance of a controlled sterilization process for a specific activity.

QMS certification standards:

  • NF EN ISO 11135-1: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • EN ISO 11137-1: Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • EN ISO 11137-2: Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
  • EN ISO 11137-3: Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
  • EN 17665-1: Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

All the clauses of ISO 13485 have numerous benefits of implementing and deeply involved in the life cycle of medical devices:

Benefits of Implementing a Sterilization Process:

1.Heightened Trust from Customers

Those medical devices that are being sterilized ensure the prevention of many health risks. Compromised medical equipment can result in fatalities, specifically when it comes to micro-organisms that can badly infect the human body.


In case of any non-conformity that occurred in the system can be corrected right away if the sterilization process contains documented records of every step hence making the whole correction process easy due to concrete trace ability of sterilization process. In case a non-conformity comes into observation during the production process, the immediate action to be taken is to stop the production process until complete traceability.

3.Risk Mitigation

By reliable traceability, the medical device industry can effectively manage the risks and can demonstrate the compliance to the highest level possible fulfilling all the legal requirements of the local and international region.

4.Enhanced Competitiveness of ISO 13485 Sterilization

The medical devices’ industry that is being able to fulfill each requirement of ISO 13485 Sterilization standard, including the needs of local regulatory authorities.

Combine your certifications to reduce time and cost

Request a Medical Device Certification

We serve the medical device industry worldwide with offices in Europe and the United States.