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2 Posts in this encyclopedia categoryBattery Act
The German Battery Implementation Act (Batteriedurchführungsgesetz, BattDG) regulates the take-back and environmentally sound disposal of batteries and accumulators. In the medical device and PPE sector it is relevant where products contain batteries (e.g. diagnostic lamps, clinical thermometers). At EU level, the new Battery Regulation (EU) 2023/1542 applies, in force since 17 August 2023 and applicable since 18 February 2024.
Biocompatibility
Biocompatibility is the ability of a material to perform with an appropriate host response when in contact with living tissue or body fluids, without causing toxic, immunological, or other harmful effects. Medical devices must be evaluated for biocompatibility in accordance with ISO 10993. Testing covers cytotoxicity, sensitisation, irritation, and genotoxicity, among others.