EU-IMPLANTABLE_MEDICAL_DEVICES-ART_3_ANX_1
EU-IMPLANTABLE_MEDICAL_DEVICES-ART_3_ANX_1
Active Implantable Medical Devices Directive - Hazardous Substances
EU. Hazardous Substances for Purposes of Directive 90/385/EEC on Active Implantable Medical Devices, 20 July 1990, amended by Directive 2007/47/EC, 21 September 2007
This list contains hazardous substances for purposes of Directive 90/385/EEC on active implantable medical devices, particularly as regards Article 3 and Annex I (Essential Requirements). This non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.
Last updated 24 April 2024. Database contains 4753 unique substances/entries.
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616-932-1
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8011-63-0
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Acute Tox. 4; Eye Dam. 1 |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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233-657-9
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10294-33-4
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Acute Tox. 2; Skin Corr. 1A |
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233-658-4
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10294-34-5
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Press. Gas; Acute Tox. 2; Skin Corr. 1B |
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231-569-5
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7637-07-2
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Press. Gas; Acute Tox. 2; Skin Corr. 1A |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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249-205-9
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28772-56-7
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Repr. 1B; Acute Tox. 1; STOT RE 1 |
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232-572-4
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9001-00-7
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1 |
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231-778-1
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7726-95-6
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Acute Tox. 2; Skin Corr. 1A |
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201-175-8
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79-08-3
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Acute Tox. 3; Skin Corr. 1A; Skin Sens. 1 |
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203-623-8
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108-86-1
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Flam. Liq. 3; Skin Irrit. 2 |
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DBBT
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402-210-1
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99688-47-8
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STOT RE 2; Skin Sens. 1 |
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200-825-8
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74-96-4
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Flam. Liq. 2; Carc. 2; Acute Tox. 4 |
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209-800-6
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593-60-2
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Press. Gas; Flam. Gas 1; Carc. 1B |
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236-129-6
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13181-17-4
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Acute Tox. 4 |
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200-854-6
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75-25-2
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Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2 |
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200-813-2
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74-83-9
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Press. Gas; Muta. 2; Acute Tox. 3; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
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218-277-3
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2104-96-3
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Acute Tox. 4 |
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225-399-0
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4824-78-6
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Acute Tox. 3; Acute Tox. 4 |
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216-882-7
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1689-84-5
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Repr. 2; Acute Tox. 2; Acute Tox. 3; Skin Sens. 1 |
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260-300-4
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56634-95-8
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Repr. 2; Acute Tox. 4; Skin Sens. 1 |
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216-885-3
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1689-99-2
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Repr. 2; Acute Tox. 3; Acute Tox. 4; Skin Sens. 1 |
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200-143-0
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52-51-7
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Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1 |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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227-317-9
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5786-97-0
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Acute Tox. 2 |
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225-432-9
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4845-99-2
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Acute Tox. 2 |
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206-614-7
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357-57-3
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Acute Tox. 2 |
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P Parasites |
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P Parasites |
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208-077-4
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507-60-8
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Acute Tox. 2 |
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620-359-2
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8065-36-9
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Acute Tox. 3 |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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34492-97-2
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Carc. 1A; STOT RE 1; Skin Sens. 1 |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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255-391-2
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41483-43-6
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Carc. 2; Skin Sens. 1B |
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B Bacteria and similar species |
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B Bacteria and similar species |
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203-449-2
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106-98-9
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Flam. Gas 1; Press. Gas |
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203-788-6
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110-65-6
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Skin Corr. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1 |
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200-751-6
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71-36-3
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Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1 |
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203-448-7
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106-97-8
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Flam. Gas 1; Press. Gas |
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