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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 05 December 2023. Database contains 4753 unique substances/entries.
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239-309-2
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15263-52-2
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Acute Tox. 4 |
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-
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-
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B Bacteria and similar species |
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226-031-1
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5234-68-4
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STOT RE 2; Skin Sens. 1 |
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259-565-9
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55285-14-8
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Acute Tox. 2; Acute Tox. 3; Skin Sens. 1 |
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212-324-1
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786-19-6
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Acute Tox. 3 |
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240-408-8
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16337-84-1
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1 |
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200-262-8
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56-23-5
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Carc. 2; Acute Tox. 3; STOT RE 1 |
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211-128-3
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630-08-0
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Flam. Gas 1; Press. Gas; Repr. 1A; Acute Tox. 3; STOT RE 1 |
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200-843-6
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75-15-0
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Flam. Liq. 2; Repr. 2; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2 |
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216-353-0
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1563-66-2
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Acute Tox. 2 |
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240-286-6
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16118-49-3
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Carc. 2; Repr. 1B; Acute Tox. 4 |
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234-232-0
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10605-21-7
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Muta. 1B; Repr. 1B |
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200-555-0
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63-25-2
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Carc. 2; Acute Tox. 4 |
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229-879-0
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6804-07-5
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Flam. Sol. 1; Carc. 1B; Acute Tox. 4 |
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205-087-0
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133-06-2
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Carc. 2; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1 |
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219-363-3
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2425-06-1
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Carc. 1B; Skin Sens. 1 |
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-
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P Parasites |
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P Parasites |
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F Fungi |
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F Fungi |
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-
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B Bacteria and similar species |
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-
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B Bacteria and similar species |
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-
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-
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B Bacteria and similar species |
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232-283-3
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8001-35-2
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Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2 |
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-
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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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243-873-5
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20548-54-3
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
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215-709-2
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1344-81-6
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
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215-142-0
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1305-99-3
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Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1; Eye Dam. 1 |
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Z 7
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402-040-8
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148262-93-5
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Skin Corr. 1B |
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-
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-
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Expl. |
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231-908-7
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7778-54-3
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Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1B |
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232-189-2
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7789-78-8
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Water-react. 1 |
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209-740-0
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592-01-8
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Acute Tox. 2 |
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205-861-8
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156-62-7
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Acute Tox. 4; STOT SE 3; Eye Dam. 1 |
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237-366-8
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13765-19-0
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Carc. 1B; Acute Tox. 4 |
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233-140-8
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10043-52-4
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Eye Irrit. 2 |
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200-848-3
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75-20-7
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Water-react. 1 |
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231-904-5
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7778-44-1
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yes |
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PIGMENTGELB 82 897
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400-710-4
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94612-72-3
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Acute Tox. 4 |
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Z-28
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421-670-4
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1379765-16-8
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Skin Irrit. 2 |
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231-179-5
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7440-70-2
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Water-react. 2 |
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200-362-1
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58-08-2
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Acute Tox. 4 |
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241-084-0
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17010-21-8
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Acute Tox. 3; Carc. 2; STOT RE 2 |
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231-152-8
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7440-43-9
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Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1 |
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231-152-8
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7440-43-9
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yes |
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231-152-8
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7440-43-9
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Pyr. Sol. 1; Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1 |
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215-147-8
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1306-23-6
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Carc. 1B; Muta. 2; Repr. 2; STOT RE 1; Acute Tox. 4 |
yes |
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233-331-6
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10124-36-4;31119-53-6
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yes |
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233-331-6
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10124-36-4;31119-53-6
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Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1 |
yes |
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215-146-2
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1306-19-0
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Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1 |
yes |
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