Processus d'inspection des produits médicaux pour seringues jetables

1.Rapport d'essai de biocompatibilité

La biocompatibilité du dispositif a été évaluée conformément à la norme en ISO 10993 - 1 et les éléments de test ont été sélectionnés en conséquence. Les résultats de l'évaluation et des essais ont montré que, compte tenu des risques, la biocompatibilité du dispositif était jugée appropriée pour l'utilisation prévue. Une évaluation détaillée de la biocompatibilité figure à l'annexe no ll / qs9.2 / 01 / 1301.

Résultats de détection selon le rapport d'examen de type de seringue sous - cutanée stérile jetable délivré par l'autorité compétente de l'Institut d'inspection des dispositifs médicaux de Jinan de l'administration nationale de la surveillance des aliments et des médicamentsCytotoxicité, irritation, sensibilisationToxicité systémique (aiguë) et compatibilité hématologique, il a été conclu que la biocompatibilité du produit répondait aux exigences essentielles de la MDD.

2.Propriétés physiques et chimiques

The physical and chemical properties have been defined in product specification which are raised from design output and Essential Requirements.

The type test reports of finished products concerning physical and chemical properties are provided in attachmen。

       3. Usability evaluation

The hazards and hazardous situation related to the usability have been taken into consideration during risk management process, and the mitigation measures are documented in risk management file. Usability engineering of the device is conducted according to EN 62366 and the result is documented in Usability Evaluation Report. Refer to attachment # LL/QS9.2/01/1302.

      4 .Packaging evaluation

The products are packaged in sterile barrier packaging system which aims to ensure the sterile condition of the products inside the packaging within specified shelf life. The primary package is paper-polypouchandplastic/blisterbox sealed by heat-sealing machine.

The primary packaging process is evaluated and validated according to EN ISO 11607-1/2. A validation group is established to coordinate and implement the validation, following the validation procedure.

Validation protocol has been established and implemented by the validation group. Validation report has been reviewed, approved and signed by the validation group. According to the validation result, routine operation and control work instruction for primary packaging has been established in work instruction.

The processes will be revalidated if changes are made to the equipment, product, packaging materials or packaging processes and etc., which compromise the original validation and affect the sterility, safety or efficacy of the sterile products. Annual revalidation or reviews will also be performed and documented to evaluate the efficacy of the previous validation result.

Refer to attachment

Packaging qualification validation report of Sterile hypodermic syringes for single use #LL/WI7.5.7b/03

Shelflife validation report of sterile hypodermic syringes for single use #LL/WI7.5.7b/05/01

      5. Sterilization

The product is supplied sterile, and sterilized by EO sterilization to ensure SAL≥ 10 ^-6. The EO sterilization is conducted in-house.

We has established a QM system according to EN ISO 13485 for provision of EO sterilization service of medical device according to EN ISO 11135, and under annual surveillance audit by the Certification Body.

The sterilization process has been validated according to EN ISO 11135, which has thereby determined the routine control and monitoring parameters. The validation and re-validation is conducted according to EO sterilization validation procedure, and the result is documented in EO sterilization validation report.

For routine release of sterilization, the sterilization certificate will be provided for each sterilization batch, reviewed and approved by Quality Department.

Sterilization validation report please refer to attachment #LL/WI7.5.7a/02/02