Remarkable Benefits: Guide to ISO 13485 Sterilization Requirements

What is ISO 13485 sterilization requirement? One of the must-haves for medical device industries is to have an established set up for sterilization of medical devices. Improper sterilization can become life-threatening for patients as it may result in the transfer of pathogens between contaminated and non-contaminated locations. Improper sterilization can lead to infection after surgery, making it much more dangerous to undergo an operation.

A medical device can be described as an instrument, apparatus, machine, or implant that is intended to be used to diagnose, prevent, or treat any disease or be used in any other condition prescribed by the physician.

Definition of ISO 13485 Sterilization requirements

Sterilization requirement is a core functionality in medical professions. By performing this process, medical personnel ensures that the apparatus used in any medical procedure is free of contaminations and pathogens that may introduce complications. Sterilization is an in-depth cleaning methodology that goes deeper than conventional cleaning processes. The requirements for sterilization are covered in ISO 13485:2016.

Many medical devices and surgical instruments are often used more than once during numerous surgeries and occasionally with several patients. To limit the transfer of pathogens from one person to another, it is essential to sterilize the surgical instruments after being used in any surgery to avoid contamination by micro-organisms. Numerous methods have been used to sterilize medical surgical instruments, including:

  • Autoclaving radiation
  • Ethylene Oxide (ETO) Sterilization
  • Chlorine Dioxide Sterilization
  • Hydrogen Peroxide Sterilization
  • And other ways.

Is it Necessary to Sterilize Surgical Instruments?

As ISO 13485 Sterilization requirements emphasize, it is important to ensure patients’ safe medical conditions during any surgery. The whole purpose of providing this sterilization is to eliminate any possible chance of surgery-induced diseases and other related medical issues.

A patient’s safety during any medical procedure is of tantamount importance. There are several reasons why sterilization is so vital to achieving this end goal:

  1. The sterilization process stops the reproduction of pathogens on the surface of medical equipment. This cessation of growth of the colony lowers the number of organisms and makes it less likely to spread diseases between theaters of operation.
  2. Lethal diseases can be stopped outright by destroying the disease-causing organisms through sterilization.
  3. Sterilization reduces the chances of complications and the need for more surgeries to achieve the desired results.

How to Follow ISO 13485 to Comply with Sterilization Requirements

The requirements for sterilization can be found within the ISO 13485:2016 standard. The clauses that cover the sterilization of equipment include:

  1. Clause 3.20: Sterile Medical Device

Most authorities provide detailed guidelines about the levels of sterility they accept. The regulatory authorities that form the bodies that oversee your intended market will inform you of the required standards for your sterilization procedure to follow.

  1. Clause 6.4.2: Contamination Control

ISO 13485 6.4.2 clearly outlines how to prevent contamination after devices are sterilized. This preventative procedure is done with engineering controls like dust collectors and ventilation systems by monitoring air quality at a defined frequency. The results can be recorded before and after sterilization.

  1. Clause 7.5.5: Particular Requirements for Sterile Medical Devices

Clause 7.5.5 states requirements in the form of two sets, which are:

  • All the records of sterilization process parameters for every batch have to be maintained and recorded. The sterilization process parameters can include various constraints to be registered, like temperature, pressure, gas flow, humidity level, and environmental conditions. The personnel in charge of sterilization may also need to be noted since the human factor may significantly affect the result.
  • Every batch of sterilization needs to be traceable, which means getting back the information where it was packed, shipped with complete sterilization records.
  1. Clause 7.5.7: Sterilization Process Validation and Sterile Barrier Systems

Clause 7.5.7 declares two sets of requirements, which are:

  • Sterilization Process Validation: It’s not sufficient to only carry out the sterilization process. It is equally important to validate the sterilization method. The review of the validation process will further highlight any need to change the process or product.
  • Sterile Barrier System‘s Validation: A Sterile Barrier System has one requirement in its installation – it should have sufficient enough barrier to prevent recontamination of previously sterilized equipment. A sterile barrier can be engineered in a control room containing bio-sensors for medical devices’ packaging with appropriate alarms indicating any signs of bio-contamination. Furthermore, it should be able to prevent any cross-contamination about to happen. Such Sterile Barrier Systems need to be validated if an amendment is required for the design change, or any parameter control has to be changed.

Benefits of Implementing Rock Solid Sterilization Process

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

  1. Sterilization Strengthens Customers’ Trust

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.

  1. Easy Traceability

If any non-conformity occurred within the system, it could be corrected right away if the sterilization process is adequately documented. Non-conformities can be traced along the route of documentation to find the problem within the process. If a non-conformity shows up during manufacture, the accepted response is to stop manufacture until a complete investigation is undertaken.

  1. Management of Risks

By reliable traceability, the medical device industry can effectively manage the risks. It can demonstrate compliance to the highest level possible, fulfilling all the authority’s legal and regulatory requirements that oversee each market.

  1. Competitive Advantage of ISO 13485 Sterilization

Businesses that conform to the standard have a competitive edge over other companies. By demonstrating compliance with ISO 13485 sterilization, a business’s products become more attractive to potential buyers, especially those that pay close attention to international standard testing.

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About Author

Sunita Verma, Founder and President of Sync Resource started the company in 2009 with a vision to provide management consulting to small & medium size businesses around the country.
Sunita holds a Master’s Degree in Mechanical Engineering from Cleveland State University, Cleveland, Ohio, Bachelors in Mechanical Engineering(India) with prestigious gold medal by then President of India and renowned Scientist Dr. A.P.J. Abdul Kalam.
As an active philanthropist she believes in pay it forward and is a contributing member of charitable organizations like St. Jude’s Foundation and North Fulton Charities.


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