ISO 11137-3:2017 Sterilization of Healthcare Products

ISO 11137 is a standard that deals with the process of sterilization of healthcare products. This standard comprises three versions altogether.

In general, all versions of this standard deal with various aspects of sterilization of healthcare products that use radiation. In particular, versions 1 and 2 of ISO 11137 set some requirements regarding radiation devices that emit gamma radiation.

ISO 11137-1:2006 sterilization of healthcare products (Radiation-Part 1)

This version of the standard deals with

  • Development
  • Validation
  • Routine control of a sterilization process for medical devices.

ISO 11137-2:2006 sterilization of healthcare products (Radiation-Part 2)

This version of the standard focuses on the establishment of a sterilization dose.

ISO 11137-3:2017 sterilization of healthcare products (Radiation-Part 3)

Part 3 of ISO 11137 helps medical device manufacturers comply with the requirements of ISO 11137-1, ISO 11137-2, and ISO/TS 1 3004.

Essential Features of ISO 11137 (Parts 1-3)

Details of Product Families & Processing Categories

All three versions of ISO 11137 provide details of product families used in the sterilization of medical devices. They also list down different product categories that help in grouping and classification of these products.

Requirements for Establishment of Radiation Dose

ISO 11137 helps medical device manufacturers in the establishment of a radiation dose for sterilization.

Providing Understanding of Gamma Radiation Validation Report

Manufacturers who show compliance to ISO 11137’s requirements have a sound understanding of the gamma radiation validation report.

Dose Audits and Re-qualification

ISO 11137 helps manufacturers in identifying requirements for continued control, including dose audits and re-qualification.

ISO 11137-3 & Its Benefits for Medical Device Manufacturers

ISO 11137-3 helps medical device manufacturers meet the sterilization requirements given in ISO 11137-1 and ISO 11137-2. A manufacturer who is compliant with ISO 11137-3 enjoys many benefits such as those given in the illustration below:

Fulfilling Essential Regulatory Requirements

An ISO 11137-3 compliant medical device manufacturer can fulfill essential regulatory requirements. For example, an ISO 11137-3 compliant manufacturer can meet 94/42/EEC’s needs, which requires medical device manufacturers to use a validated sterilization process.

Having a Knowledge of Microbiological Requirements

A medical device manufacturer compliant with ISO 11137-3 has a sound knowledge of microbiological requirements such as

  • pre-sterilization bioburden control
  • awareness of test methods devised by ISO 11137-1 and ISO 11137-2 for bioburden and sterility testing used in process validation.

Learning to Distinguish between Various Types of Radiation Processes

Medical device manufacturers who comply with ISO 11137-2 learn to differentiate between various radiations used in the sterilization process. The manufacturer also knows various aspects of multiple radiations used in the sterilization process (e.g., Gamma, Electron beam, and X-ray, etc.) The standard also helps the manufacturer in understanding basic concepts of Gamma radiation sterilization.

Having a Knowledge of Outsourced Sterilization

An ISO 11137 compliant manufacturer understands different ways through which he can monitor and control outsourced sterilization.

Complying to Notified Body’s Requirements

ISO 11137-3 helps medical device manufacturers in becoming aware of Notified Body’s auditing requirements.

Looking Forward to Becoming an ISO 11137 Compliant Medical Device Manufacturer?

TSQ&E helps medical device manufacturers around Europe in becoming compliant with ISO 11137. We excel in assisting in areas of radiation sterilization and provide up-to-date training to the medical device manufacturers of Europe concerning the implementation of ISO 11137. To become an ISO 11137 compliant medical device manufacturer, contact us today by visiting our website tsquality.ch

About the Author

Waqas Imam

S. M. Waqas Imam is associated with TS Quality as a Regional Partner. He is also an ambassador of Medical Device Community. He is an Industrial Engineer by qualification and served the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor of ISO 9001 and other management system standards. He had served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA. He also served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.