Validation of Process for Sterilisation and Sterile Barriers Systems - ISO 13485

ISO 13485: 2016 +A11 2021 

QMS.7.5.7 - QP - Validation of Processes for Sterilisation and Sterile Barrier Systems Procedure Template 

Ethylene Oxide Method 

Our Medical Device Quality Assurance and Regulatory Affairs document templates have been created by fully qualified and experienced professionals at Patient Guard, a Quality Assurance and Regulatory Affairs Service provider. The templates have been specially written to ensure that they meet the basic requirements needed for each clause/section of the standard or regulation the templates relate to. We have carefully curated the templates to ensure they are easy to follow and adapt to make them specifically modified to your business needs. All the templates are fully editable Microsoft word documents allowing you to have complete control over the templates which can then be modified to suit your company branding/marketing requirements.

Why do I need to Validate Sterilisation of my medical device?

• ISO 13485 requires that your organisation document procedures for the validation of processes for sterilisation and sterile barrier systems.
• Your organisation should validate processes for sterilisation and sterile barrier systems prior to implementation and following product or process changes, as appropriate.
• The standard also requires that records of the results and the conclusions of validation along with necessary actions should be maintained.
• If you have a non-sterile medical device, then this section of the standard does not apply.

How will the template help me meet the requirements of the standard?

• The template will help you write a procedure to:
  • identify your medical device’s requirements for validation of sterilisation,
  • identify your medical device’s requirements for sterile barrier systems.
• The template is customisable to your organisation and medical device.

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.

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