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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 19 April 2024. Database contains 4753 unique substances/entries.
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P Parasites
208-077-4
507-60-8
Acute Tox. 2
620-359-2
8065-36-9
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
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.
255-391-2
41483-43-6
Carc. 2; Skin Sens. 1B
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B Bacteria and similar species
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B Bacteria and similar species
203-449-2
106-98-9
Flam. Gas 1; Press. Gas
203-788-6
110-65-6
Skin Corr. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1
200-751-6
71-36-3
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
203-448-7
106-97-8
Flam. Gas 1; Press. Gas
203-448-7
106-97-8
Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
202-496-6
96-29-7
Carc. 1B; Acute Tox. 4; Acute Tox. 3; STOT SE 3; STOT SE 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
201-159-0
78-93-3
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-452-9
107-01-7
Flam. Gas 1; Press. Gas
252-139-3
34681-10-2
Flam. Liq. 3; Acute Tox. 3; Eye Irrit. 2
BUTROXYDIM; ICIA0500
414-790-3
138164-12-2
Repr. 2; Acute Tox. 4; Skin Irrit. 2
TILCOM CA35; TILCOM IA10; TYTAN AP 100; TYTAN CA 100; TYTAN CX 35; TYZOR IAM
401-100-0
109037-78-7
Flam. Liq. 2; Eye Irrit. 2
202-318-7
94-26-8
yes
203-656-8
109-21-7
Flam. Liq. 3
209-750-5
592-34-7
Flam. Liq. 3; Acute Tox. 3; Skin Corr. 1B
209-772-5
592-84-7
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
219-376-4
2426-08-6
Flam. Liq. 3; Carc. 2; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Sens. 1
208-862-1
544-16-1
Flam. Liq. 2; Acute Tox. 3
203-699-2
109-73-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
230-358-5
7067-44-9
Acute Tox. 4
204-646-6
123-72-8
Flam. Liq. 2
203-792-8
110-69-0
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
203-532-3
107-92-6
Skin Corr. 1B
205-498-5
141-75-3
Flam. Liq. 2; Skin Corr. 1B
204-650-8
123-77-3
Resp. Sens. 1
yes
208-953-6
548-62-9
yes
208-953-6
548-62-9
Carc. 1B; Acute Tox. 4; Eye Dam. 1
208-953-6
548-62-9
Carc. 2; Acute Tox. 4; Eye Dam. 1
220-600-8
2832-40-8
Carc. 2; Skin Sens. 1
212-668-2
842-07-9
Carc. 2; Muta. 2; Skin Sens. 1
ORASOL BLAU 761B
414-110-5
1379678-96-2
Eye Dam. 1
CD 23-404
404-750-3
119415-07-5
Acute Tox. 4; Skin Corr. 1B
417-360-3
1379678-84-8
Acute Tox. 4; Skin Irrit. 2
INTERSEPT
404-690-8
68132-19-4
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
208-168-9
513-78-0
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes
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cadmium chloride (CdCl2), hydrate (2:5) EC / List no: 640-998-0 | CAS no: 7790-78-5
233-296-7
10108-64-2
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
640-998-0
7790-78-5
yes
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Acute Tox. 4
208-829-1
542-83-6
Acute Tox. 2; Acute Tox. 1; Carc. 2; STOT RE 2
224-729-0
4464-23-7
Acute Tox. 3; Carc. 2; STOT RE 2
232-222-0
7790-79-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
244-168-5
21041-95-2
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes

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