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.

You are highly encouraged to use these checklists and submit structured data for assessment. Multiple checklists are ready for download.

Importance of using checklists to submit well-structured data

Well-structured data compilation for biological safety assessment (sterilisation, packaging, biocompatibility, reprocessing) is mandatory for every initial certification, certificate renewal and change notification (where biological safety aspects are affected) of all devices subject to assessment of technical documentation in accordance with MDR Annex IX.4.

We also recommend using the checklists for submissions in relation to MDR Annex IX. 3, Article 52.1c and Annex XI Part A for surveillance assessments of biological safety aspects such as sterilisation and sterile packaging processes as well as instructions for reusable devices.

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? A fully completed checklist will help you to avoid overlooking or omitting essential data. This allows for highly effective work on our part.

What to do with the checklist?

A checklist is compiled to cover for one production process (Sterilization, Packaging) or one medical device in question (Biocompatibility, Reprocessing) that is described in a technical documentation.

If multiple processes are applicable for manufacturing of the medical device, a checklist should be filled in for each process to keep a structured overview. Failing to do so may result in a longer processing period, as our team will need more time to process the information.

Please submit the completed checklist to your TÜV SÜD Client representative after finalization.  If you are not a TÜV SÜD client and would like to request for our services, please fill in the contact form here.

STERILE PACKAGING
STERILE PACKAGING CHECKLIST *updated on 21 April 2021

BIOCOMPATIBILITY CHECKLIST *updated on 15 April 2021

ETHYLEN OXIDE STERILISATION CHECKLIST *updated on 7 March 2023

IRRADIATION STERILISATION CHECKLIST *updated on 1 March 2023

MOIST HEAT STERILISATION CHECKLIST *updated on 7 March 2023

GENERAL NSM CHECKLIST*updated on 16 January 2023

H2O2 PLASMA REPROCESSING CHECKLIST *updated on 12 January 2023

H2O2 PLASMA STERILISATION CHECKLIST *updated on 12 January 2023

ASEPTIC PROCESSING CHECKLIST *updated on 12 January 2023

PROCEDURE REVIEW CHECKLIST  *updated on 12 April 2023

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.