Manufacturers of Medical Devices, you want to analyze your products according to the NF S94-091 standard
What is the NF S94-091 standard?
First of all, the NF S94-091 standard is the former title of the standard now known as ISO 19227. Thus, it is a document that defines the validation requirements for the cleaning process of orthopedic implants before final packaging. In fact, it specifies the test methods to be used for the validation of the cleaning process and the controls.
The objective of this standard is to guarantee the physico-chemical and microbiological cleanliness of orthopaedic implants. These can be :
- joint prostheses
- spinal implants
- osteosynthesis material, etc…
Moreover, orthopaedic implants can be coated or uncoated metallic implants, ceramic, polymer, multi-material, composite implants, intended to be sterilized.
Pourquoi analyser vos dispositifs médicaux selon la norme NF S94-091 ?
The analysis of your medical devices, especially orthopedic prostheses, according to the NF S94-091 standard allows you to check the conformity of your finished products.
Indeed, medical devices are particularly controlled because of their contact with the patient’s body.
Thus, the support of a laboratory specialized in the analysis of orthopedic implants for the verification of the conformity of your products is an essential asset for their marketing.
FILAB supports you in the analysis of your medical devices according to the NF S94-091 standard
As an expert in the field of analysis for the medical sector, the FILAB laboratory accompanies you at each stage of the analysis of your Orthopaedic Implants according to the NF S94-091 standard, using validated and documented methods.
Our experts are at your disposal and offer you their analysis services in accordance with the NF S94-091 standard.
To go further
ISO 10993-13 and ISO 10993-14: Identification and quantification of degradation products of polymeric and ceramic medical devices
ISO 10993-22: Characterization of nanomaterials
ISO 10993-7 : Determination of ethylene oxide and ethylene hydrochloride
ISO 10993-19: PMT characterization (physicochemical, morphological and topographical)
