What is the ISO Standard for Medical Device Sterilisation?

In this blog, we will look at each ISO medical Standard involved with device sterilisation and examine the industry best practices to maintain compliance.

Understanding ISO Standards for Medical Device Sterilisation

Key ISO Standards to ensure medical devices are free from contaminants and pathogens before use are:

• ISO 11135 (Ethylene oxide sterilisation)—Ethylene oxide is a flammable gas which is sweet-smelling and colourless. In small amounts, it is an effective sterilising agent. However, because this is an explosive gas and is also toxic to animals and humans, ISO 11135 has strict parameters concerning temperature, gas concentration, exposure time, and humidity.
• ISO 11137 (Radiation sterilisation)—This uses ionising radiation (radiation strong enough to detach an electron from an atom) to cause genetic damage and death to microorganisms such as viruses, bacteria, or fungi. Metal medical devices are suitable for this type of sterilisation, but plastic devices can become discoloured or brittle.
• ISO 17665 (Moist heat sterilisation)—Also called steam sterilisation, this method uses pressurised steam to kill harmful microorganisms. After this sterilisation, adequate time must be allowed for the devices to fully dry and cool. The ISO Standards for medical devices PDF that outlines all of the moist heat sterilisation guidelines can be purchased here.

Why ISO Standards Matter in Medical Device Sterilisation

Why is ISO compliance so important in medical device sterilisation? Consider the case of a medical device that enters a part of the human body which is normally sterile. The only way to ensure that the patient will be safe from infection is by rigorously following the device sterilisation protocols laid out in the ISO Standards. These Standards are also the best way to comply with strict global regulatory requirements, especially for manufacturers. ISO (International Organisation for Standardisation) is a global network which gathers leading experts from across the world to develop the best way of doing things, which then become the International Standards.

Key ISO Standards for Medical Devices

Besides sterilisation processes, there are other essential ISO Standards that apply to medical devices. These Standards work together to ensure that adequate systems are in place to guarantee the safety, sterility, and compliance concerning medical devices at each point of the supply chain. Some of the key Standards are:

• ISO 13485 (Quality management systems for medical devices): This quality management is applied throughout the lifecycle of each medical device and includes various stages such as design, production, distribution, and technical support.
• ISO 14971 (Risk management for medical devices): This Standard applies to all stages of the medical device’s lifecycle and helps manufacturers identify any hazards concerning the device and to estimate any risks. Then, controls are put in place and monitored for effectiveness.
• ISO 15223-1 (Labelling requirements for medical devices): Medical device manufacturers must put specific information on the device or its packaging. Due to these devices being shipped to foreign countries, this Standard allows for the information to be shown in the form of symbols which have a specific meaning.
• ISO 11607 (Packaging requirements for sterilised medical devices): This Standard concerns sterile barrier packaging systems which maintain the sterility of the medical devices until they are used.

ISO Packaging Standards for Medical Devices

The ISO packaging Standards for medical devices are contained in ISO 11607 and cover three main areas:

• Packaging design and validation requirements: This means that the materials used in the sterile packaging must be reliable and repeatable and that the package itself can be safely transported. It must also be tested for its shelf life and usability by its end user.
• Sterility maintenance throughout the supply chain: This requires a sterile barrier system where the packaging prevents the entrance of microorganisms and maintains the sterility of the medical device until the end user opens the package.
• Best practices for compliance: These are clearly outlined throughout ISO 11607.

ISO 15189: The Standard for Medical Laboratories

The ISO 15189 Standard for medical laboratories addresses areas such as quality management and testing reliability. It covers all stages of the pathology testing process and particularly applies to sterilisation processes and laboratory operations. The ISO 15189 Standard is used for pathology accreditation and by regulatory bodies.

How to Access ISO Standards for Medical Devices (PDF Guide)

You can access the official ”family” of  ISO Standards for medical devices on this website. The links to the PDF for each Standard mentioned in this blog are ISO 11135, ISO 11137, ISO 17665, ISO 13485, ISO 14971, ISO 15223-1, ISO 11607, and ISO 15189. These PDFs can also be purchased from the ISO website, regulatory bodies, and industry organisations.

Please note that the PDFs for these ISO Standards are subject to licensing rules, and compliance requires that unauthorised copies not be used.

Ensuring Compliance with ISO Medical Standards

Here is a step-by-step guide for a manufacturer to achieve compliance with medical device ISO Standards:

• Conduct risk assessments by identifying hazards, estimating the risks and putting effective controls in place.
• Implement quality management systems through each stage of your medical device's lifecycle, such as design, production, distribution, etc.
• Performing validation and verification testing to ensure that your materials and processes are reliable, repeatable, usable and have the expected shelf life.
• You can undergo regulatory audits and certification when the above steps are in place.

Common Challenges in ISO Compliance & How to Overcome Them

Some common ISO compliance issues are:

• Insufficient “buy-in” or support from the team or management
• Documentation errors, such as misplaced paperwork
• Not allocating the appropriate resources to achieve ISO compliance and certification
• Being unaware of regulatory changes or revisions to the ISO Standards

A practical solution for ensuring ongoing compliance with an ISO medical Standard is to train all your team members on the relevant Standard and any regulatory changes. With everybody on the same page, management can inspect and repair any breakdowns in the compliance chain (such as documentation errors, etc.).

Conclusion

ISO Standards for medical devices are essential for sterilisation, safety, workability, and obtaining regulatory approval.

Intertek Inform can provide you with expert guidance for your manufacturing compliance needs.