歐盟 RoHS 醫療設備和監控儀器新增禁限用四項可塑劑要求! - 立雍科技實業有限公司｜膠合棧板｜紙棧板｜木棧板｜護角紙

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News > EU RoHS Directives and Regulations > EU RoHS adds new restrictions on the use of four plasticizers in medical devices and monitoring instruments!

EU RoHS adds new restrictions on the use of four plasticizers in medical devices and monitoring instruments!

2025-07-14

On June 4, 2015, the European Union officially announced the addition of four phthalates to the list of prohibited and restricted substances (Annex II) of the RoHS (recast) Directive (2011/65/EU). This addition took effect on July 22, 2021, for medical devices and monitoring instruments. From then on, all products covered by RoHS control must comply with the requirements of the 10 RoHS restricted substances.

Medical device manufacturers exporting to Europe must also pay attention to the EU Medical Device Directive (MDR). If you need to export medical devices to Europe, SGS can provide comprehensive testing and other related services, allowing you to more easily meet the new requirements for medical devices and promote smoother marketing. If you have any questions, please feel free to contact us.

The substances and concentration limits currently regulated in the List of Prohibited and Restricted Substances (Annex II) (single homogeneous material) are:

controlled substances	Concentration limit (ppm)
鎘 (Cadmium)	100
鉛 (Lead)	1,000
六價鉻 (Chromium VI)	1,000
汞 (Mercury)	1,000
多溴聯苯 (PBB)	1,000
多溴聯苯醚 (PBDE)	1,000
鄰苯二甲酸二(2-乙基己基)酯 (DEHP)	1,000
鄰苯二甲酸丁苯甲酯 (BBP)	1,000
鄰苯二甲酸二丁酯 (DBP)	1,000
鄰苯二甲酸二異丁酯 (DIBP)	1,000

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