What testing properties have to be fulfilled by the manufacturer?
The replacement of the MDD by the MDR will be accompanied with an amendment of the DIN EN ISO 10993, the document which regulates the chemical and biological analytics of the manufacturers’ products in 20 independent guidelines. The ISO 10993 regulates the testing strategy of every individual medical device according to its contact time and contact properties (e.g. superficial vs. blood contact or implanted) with a strong bias on the chemical composition, pyrogenic /cytotoxic properties and microbiological contamination.
ISO 10993 clearly indicates that in vitro test systems have to be preferred to animal studies whenever this is possible. Another important aspect is represented by the fact that the manufacturer has to assess the biological safety of defined medical device during its entire life cycle. In this context reusable medical devices have to be assessed according to their validated application cycles.
Biocompatibility-tentamedix-biological-safety
To offer a maximum of support for the medical device manufacturers Tentamus has implemented a sophisticated test platform covering the entire in vitro testing part of the DIN ISO 10993, in detail
Chemical characterisation of medical devices (ISO 10993-18)
Determination of ethylene oxide residuals (ISO 10993-7)
Determination of cytotoxicity in-vitro (ISO 10993-5)
Determination of microbiological contamination (Bioburden) and sterility (ISO 11737-1 / -2)
Determination of bacterial endotoxin and non-endotoxin pyrogens (LAL- und MAT: Ph. Eur. 2.6.14 / 2.6.30)
Determination of skin irritation in-vitro: ISO 10993-10 (10993-23 (Draft)) / OECD TG 439
Determination of skin corrosion in-vitro (OECD TG 431)
Determination of ocular irritation (OECD TG 460)
Determination of sensitization in-vitro (OECD TG 442d/e)
Determination of genotoxic effects (ISO 10993-3)
Determination of hemocompatibility (ISO 10993-4)
An individual testing strategy for each medical device has to be prepared by the manufacturer and presented to the notified body for market registration. The Tentamus group supports manufacturers on the analytical testing requested by a manufacturer having its strategy in place. In case no testing strategy is in place yet, the Tentamus Group supports the preparation of the testing strategy beforehand, in cooperation with consultants. This ensures the safety of both the product and patient.
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
