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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 18 April 2024. Database contains 4753 unique substances/entries.
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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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Acute Tox. 2; Acute Tox. 1; STOT RE 2
231-442-4
7553-56-2
Acute Tox. 4
200-590-1
64-69-7
Acute Tox. 3; Skin Corr. 1A
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696-33-3
Expl.
216-881-1
1689-83-4
Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2
223-375-4
3861-47-0
Repr. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
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115850-69-6
Repr. 1B; Acute Tox. 4; STOT RE 2
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115937-89-8
Repr. 1B; Acute Tox. 4; STOT RE 2
603-038-1
125225-28-7
Repr. 1B; Acute Tox. 4; STOT RE 2
247-449-0
26087-47-8
Acute Tox. 4
253-178-9
36734-19-7
Carc. 2
604-209-3
140923-17-7
Carc. 2
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5827-05-4
Acute Tox. 1; Acute Tox. 3
231-753-5
7720-78-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
616-510-7
7782-63-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
JOF 2822 5F; JOF 2822 5FL; JOF 4443
420-960-8
77214-82-5
Eye Dam. 1
255-863-8
42509-80-8
Acute Tox. 2; Acute Tox. 3; STOT RE 2; Skin Sens. 1
208-746-0
540-42-1
Flam. Liq. 3
206-045-4
297-78-9
Acute Tox. 1; Acute Tox. 2
200-857-2
75-28-5
Flam. Gas 1; Press. Gas
200-857-2
75-28-5
Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
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51337-71-4
Acute Tox. 4
IVAX
401-920-9
100181-71-3
Skin Irrit. 2; Skin Sens. 1
203-745-1
110-19-0
Flam. Liq. 2
203-417-8
106-63-8
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
ISOBUTYLVINYL ACETATE; IVA
401-170-2
24342-03-8
Flam. Liq. 3
208-818-1
542-55-2
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
202-613-0
97-86-9
Flam. Liq. 3; STOT SE 3; Skin Irrit. 2; Skin Sens. 1B
208-819-7
542-56-3
Flam. Liq. 2; Carc. 1B; Muta. 2; Acute Tox. 4
ZOLDINE RD-4
419-850-2
148348-13-4
Skin Corr. 1B
ALKYLSILANE TZ 01748; DYNASYLAN 9405; EURENOR(R) 5020; PSX 5305
402-580-4
111439-76-0
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
201-195-7
79-31-2
Acute Tox. 4
201-194-1
79-30-1
Flam. Liq. 2; Skin Corr. 1A
207-366-2
465-73-6
Acute Tox. 2; Acute Tox. 1
202-590-7
97-54-1
Skin Sens. 1A
246-814-1
25311-71-1
Acute Tox. 3
250-610-8
31394-54-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
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yes
234-284-4
11066-49-2
yes
609-346-2
37205-87-1
yes
247-861-0
26635-64-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
249-707-8
29590-42-9
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
201-142-8
78-78-4
Flam. Liq. 1; Asp. Tox. 1; STOT SE 3
204-662-3
123-92-2
Flam. Liq. 3
203-769-2
110-45-2
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-322-1
105-68-0
Flam. Liq. 3
201-143-3
78-79-5
Flam. Liq. 1; Carc. 1B; Muta. 2
220-114-6
2631-40-5
Acute Tox. 4
203-561-1
108-21-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3

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