ISO 13485 refers to sterilizing contaminated medical devices. What are the ISO 13485 Contamination Guidelines? Imagine being operated on with inadequately sterilized surgical tools. Seems dangerous!

During the treatment of some diseases, medical devices come in contact with humans. They need to be 100% sterilized, clean, and free from germs. Bacteria and germs can spread from one patient to another and result in various infections and life-threatening diseases.

QMS (Quality Management System) and ISO 13485 Contamination Guidelines specifically for medical devices’ industries will help meet the requirements that ensure patients’ safety.

ISO 13485 is a standard that best describes the requirement of a QMS that provides wholesome requirements for medical devices’ industries and puts an increased focus on thinking based on a risk-based approach that brings closer organizations to compliance.

The idea of the product life cycle and risk-based approach should have a purpose to minimize the harm associated with the safety and performance of medical devices.

To eliminate such health hazards, ISO 13485 has made sterilization a necessary process for every medical device. Many medical industries get confused between cleaning and sterilization and tend to use the terms interchangeably. Based on the ISO standards, these two terms mean two entirely different things.

The Difference between Sterilization and Cleanliness

Sterilization is the process in which biological contamination or biological agents are removed by decontamination. In contrast, we may define cleanliness as removing impurities present at the micro level from a medical device.

ISO 13485 Contamination Guidelines Requirements for Contamination Controls

ISO 13485, clause 6.4.4 contains a set of requirements for Contamination Control. The intention is to control contamination in medical devices to prevent health hazards.

Controlled work conditions are noted by identifying and documenting the work environment. This classification is essential so that cross-contamination cannot occur. The ideal work environment includes a contaminant waste area, appropriate equipment like dust collector systems.

The procedures used must be strictly monitored. Medical devices’ industries must identify any health hazards and requirements of their cleaning and packaging (if necessary).

Production leaders are advised to closely monitor working conditions and verify if workers are wearing unique medical clothing or uniforms provided by the pharmaceutical industry. Temporary contractual workers should get their health checked periodically, and the organization should provide training and guidance so that they can perform their assigned tasks efficiently.

Before training workers, educate their supervisors with proper post-training evaluation. Ensure that the manager and safety personnel have approved work permits.

Please be aware that sterilization is useless if contamination happens right after the sterilization process. Control of contamination from micro-organisms and substances that are particulate and exist in a working environment must be documented so that the requirement of ISO 13485 contamination control can be satisfied.

To maintain a contamination control environment, the area must have some special equipment to maintain the same. Examples include dust collectors, any particular device that can provide an accurate count of particulates in the air, any device that can give precise air quality numbers in working conditions, or any engineering or administrative control to eliminate contamination sources present in the working environment.

The following are mandatory to satisfy the requirements of ISO 13485 contamination control:

  • Good Hygiene Practices
  • Defined and followed cleaning frequencies of manufacturing plant cleaning
  • Maintenance of air vents
  • Procedure for personal clothing

Handling Contaminated / Potentially Contaminated Products

All the activities should be documented while managing contaminated products, including receiving, accepting, cleaning, segregating, and decontaminating processes along with material, spare parts, attached parts, products, or defective, finished products or products with non-conformities should be separated and controlled until the choice of complete rework, repair or disposal is determined.

Contamination Control for Sterile Medical Devices

To ensure contamination control under ISO 13485:

  • Design and document activities for contamination control for micro-organisms or particulate materials.
  • Define roles, responsibilities, and authorities
  • Develop close monitoring and precise measurement protocols for the sterile environment
  • Create preventive actions strategies
  • Note equipment Specifications
  • Verify and Validate
  • Ensure a sterile work environment with checks
  • Control change management

Cleanliness Requirements by ISO 13485

Cleanliness requirements during the assembly and packaging process have also been addressed in ISO 13485. The summarized requirements for cleanliness as mentioned in ISO 13485 are:

  1. An updated list of apparatus used in medical devices’ industries before use or sterilization. Medical devices require thorough cleaning before the sterilization process.
  2. Not all medical gear can be cleaned before sterilization, and those few devices also need to be enlisted and thoroughly documented.
  3. Enlist all medical kit delivered in non-sterile condition and need cleaning before use or sterilization. Documentation should be in accordance with contamination control requirements.
  4. Enlisted medical gear should always be cleaned before use especially when they come in non-sterile condition.
  5. All process agents must be enlisted from products during manufacturing processes with contamination control for every process agent.

How ISO 13485 ensures device safety?

ISO 13485 Contamination Guidelines help all the medical devices’ manufacturers and sellers to ensure customer safety at all costs. Each medical device has to be categorized with separate lists that will surely enable the organizations to manage operations efficiently and effectively and cleaning requirements for every product.

Are you looking to get ISO 13485 certification for your business?

Let’s help you answer those questions and take you to full certification.

Book A Call With Our Experts Now