Explained: Contamination Control by ISO 13485

contamination control by iso 13485

Contamination can be a really serious issue in any company. Especially in the medical devices industry where sterile medical products are expected to come out from the manufacturer, and later on to be used by medical staff on the patients. In the case of the non-sterile devices, because of contamination, a patient’s health can be endangered.

Every activity is causally consequential. Potential contamination might harm product performance, quality, and safety of other products. Therefore, in the medical device industry,
ISO 13485 Standard requires to establish, document, maintain

  • requirements for activities,
  • special arrangements, and
  • measures for the control of potentially contaminated,
  • contaminated or
  • returned products.

The ISO 13485 Standard sets a clear, established, and documented process to ensure that situations, where contamination is possible, are controlled and identified. In the case of the returned medical device, it has to be separated and stored in the designated area.

The medical device manufacturer has to set and document all the activities to protect employees, work environment, and of course medical products.

Those activities actually have to be related with the issues such as:

  • Product identification
  • Product revalidation
  • Product Handling
  • Service and maintenance
  • Documentation

Product identification

To identify the product is one of the controls that will help the manufacturers to distinguish contaminated products. The purpose is to identify the status of a component, product, or material regarding contamination. The identification requirements for returned medical device are specified in the standard, in clause Identification. The activities and measures of potentially contaminated products, that are described in the requirements, should be integrated. In case the procedure is developed, it will be submitted to the control of documents as required in clause Control of documents.

Product revalidation

Returned medical devices that are intended for resale, should be revalidated that they are in the same condition as a new product, before being submitted to the work environment – intact and unharmed, and the package is sealed and complete. The purpose is to ensure that the status of these products is acceptable and that there is no risk of contaminating other products, work environment, or employees. The matter is meant to include the processes of submitting medical devices to rework.

Product handling

Contaminated product handling represents all the activities such as – receiving, accepting, cleaning, segregating, and decontaminating procedures. Each part of the product that was detected with nonconformities or as defective will be segregated and controlled until its repair, rework, or disposal. The matter may be integrated with the procedure of Control of nonconforming products. Records and evidence that will be provided are according to the planned requirements.

Service and maintenance

Medical devices that were returned for service and repair should be segregated from other products. Activities regarding received devices for maintenance and service have to be done in such a way to eliminate the mixing with other devices. The matter is meant to be referred to relevant working tools and equipment when the transfer of these between products with different statuses may contaminate the product or the work environment.


In the ISO 13485 standard, the establishment of documented requirements is defined as necessary for the implementation and maintenance of the work environment conditions. If the environment isn’t maintained clean, it might harm the medical device, and the manufacturer is expected to stop the introduction of contamination into the work environment. The method for controlling contamination must be planned, defined, and maintained using documented measures. Documented measures are a documented set of operations or activities planned or classified in a logical order or sense that ensure that clean conditions of the work environment are kept and contamination is prevented. Records may appear as:

  • Outputs of the control systems, tools, or devices – printed reports, files, screens
  • Definitions of authorization and accesses to areas and sites
  • Records of environmental reviews regarding the conditions – forms, checklists, tables or charts with data
  • Process verifications and validations regarding the conditions of the work environment
  • Evidence of human resource compatibility – records of training and certifications
  • Records and evidence required by regulatory requirements

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