Biological Safety Checklists

We love to make things easier for you. That’s why we developed TÜV SÜD biological safety checklists. They help you to retrieve the summary background data necessary for biological safety (including microbiological safety) assessment. These assessments comprise topics like biocompatibility, sterilisation, reprocessing instructions, and sterile packaging validation.

Your advantages at a glance:

• Not sure what data to provide? Follow our checklist step by step to make sure that you have thought of everything.
• You favour a smooth process and quick results? A fully completed checklist will help you to avoid overlooking or omitting essential data. This allows for highly effective work on our part, a reduced number of rounds of conformity assessments, and prompt results.

Six different checklists are ready for download. We would like to encourage you to use these checklists and submit structured data for assessment.*

STERILE PACKAGING
STERILE PACKAGING CHECKLIST

BIOCOMPATIBILITY CHECKLIST

ETHYLEN OXIDE STERILISATION CHECKLIST

IRRADIATION STERILISATION CHECKLIST

MOIST HEAT STERILISATION CHECKLIST

* Please note that submitting summary background data via our checklist is no replacement for the need for detailed documentation. A separate biocompatibility checklist is required for each product / component. Documentation on a separate checklist is required for each sterilisation process in the case of sterilisation, and for each combination of sealing steps that generate a packaging design in the case of packaging.

Please note that the attached Client Checklist Biocompatibility supersedes the revision provided in the mailing dated 13 May 2020.