第51和52条限制邻苯二甲酸酯在玩具和儿童护理用品中的投放市场和使用。此项限制是否适用于雾化器等医疗器械？

第51和52条限制邻苯二甲酸酯在玩具和儿童护理用品中的投放市场和使用。此项限制是否适用于雾化器等医疗器械？

Entries 51 and 52 restrict the placing on the market and use of phthalates in toys and childcare articles. Does this restriction apply to medical devices, such as nebulisers?

医疗器械的定义载于第 2017/745 号欧盟法规第 2 条（参见：https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en#current_legislation）。第 51 和 52 条对玩具和儿童保育用品中塑化材料中的某些邻苯二甲酸酯进行了限制。医疗器械通常被认为具有与玩具和儿童保育用品不同的功能。第 51 和 52 条将儿童保育用品定义为“任何旨在促进睡眠、放松、卫生、儿童喂养或儿童吮吸的产品”。对于第 51 和 52 条所指的医疗器械是否属于儿童保育用品，应根据具体情况进行评估。以雾化器为例，该设备用于管理药品（用于治疗的设备），因此它不属于儿童保育用品，该限制不适用于它。

Medical devices are defined in Article 2 of Regulation (EU) 2017/745 (see: https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en#current_legislation). Entries 51 and 52 pose restrictions on certain phthalates in plasticised materials in toys and childcare articles. Medical devices are generally regarded to have functions different from those of toys and childcare articles. Childcare articles are defined in entries 51 and 52 as ‘…any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of the children’. Whether a medical device is a childcare article for the purpose of entries 51 and 52 should be assessed on a case-by-case basis. In the example of a nebuliser, the device is intended for administering a medicinal product (apparatus to be used for treatment) and therefore it is not a childcare article and the restriction does not apply to it.