Contact person
Louise Wogelred
Forsknings- och utvecklingsingenjör
Contact Louise
ISO 17664 Validating Instruction for Users - cleaning and disinfection
For reusable medical devices, there must be a validated Instruction for Users (IFU) for cleaning and disinfection. We assist in creating a functional instruction according to both ISO 17664-1 and ISO 17664-2 and validate that the products are properly cleaned and disinfected.
Safe products, safe patients
It is crucial to follow ISO 17664-1 and ISO 17664-2 as these standards ensure that medical devices are handled in a way that minimizes the risk of infections. Proper cleaning and disinfection are essential to prevent the transmission of harmful bacteria to patients.
By adhering to these standards, manufacturers and healthcare providers can guarantee that products are safe to use and meet regulatory requirements, such as those outlined in the MDR.
This strengthens trust in the quality and reliability of the products, while contributing to enhanced patient safety.
Method
The cleaning procedure is validated by soiling the product with appropriate contaminants, such as blood or artificial soil, followed by cleaning and analysis of any remaining soil residues through methods such as protein analysis or hemoglobin analysis, according to ISO 15883-5 (MDR) or ANSI/AAMI ST98 (FDA).
We can also evaluate automatic (thermal) disinfection with temperature probes to ensure that the product meets the expected A0 value, according to ISO 15883-1 (MDR). Manual (chemical) disinfection processes are validated according to ANSI/AAMI TIR12 (FDA).
Deliveries
Methods and results are presented in a written report, in Swedish or English.
More information
At RISE, we are pleased to offer services that ensure your products can be cleaned, disinfected, and sterilized safely and effectively according to ISO 17664-1/2, ISO 15883-5, ANSI/AAMI ST98, and ISO 17665:2024. We also provide testing services for evaluating the biocompatibility of medical devices according to ISO 10993-5:2009 and ISO 10993-23:2021.
By combining our services under these standards, we can help you ensure that your medical devices are biocompatible, sterile, and suitable for reuse—critical factors for patient safety and product success in the market.
Please feel free to contact me for a consultation.
