ProtecSom®’s anti-dust mites covers are class 1 medical device according to the European directive 93/42/CEE. They are designed for patients allergic to house dust mites and contribute actively to the reduction of symptoms linked to dust mites allergies. When used, they improve patients’ quality of life.
They are manufactures under the ISO 13485 process (norm for the fabrication of medical devices) ensuring the following features :
- Efficacy of the device : medical utility of the device is continuously demonstrated (studies …)
- Innocuity of the device : the device presents no risks to the patient (no chemical substances)
- Continuous control and traceability : permanent controls are performed to ensure the conformity of each batches to the efficacy and innocuity standards defined when first place on the market.
- Sincerity of the information provided to medical professionals and to patients : all information provided is conform to the information contained in the devices’ technical files.
- Moreover, an annual audit is performed by an independant organism. The ISO 13485 certification can be suspended in case of a major non-conformity majeure, additional proof of quality throughout the lifetime of the product. More details on the ISO 13485 certification.
Oekotex : ProtecSom®’s covers innocuity is validated by an Oekotex 100 class 1 certificate, homologation particularly for contact with babies skin.