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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 30 May 2024. Database contains 4753 unique substances/entries.
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204-495-6
121-72-2
Acute Tox. 3; STOT RE 2
210-199-8
609-72-3
Acute Tox. 3; STOT RE 2
202-805-4
99-97-8
Acute Tox. 3; STOT RE 2
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
204-493-5
121-69-7
Carc. 2; Acute Tox. 3
220-623-3
2836-04-6
Acute Tox. 3
200-316-0
57-14-7
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; Skin Corr. 1B
429-640-2
52870-46-9
Eye Irrit. 2
PPX-HCL
417-950-0
65797-42-4
Acute Tox. 4
423-840-3
14691-89-5
Acute Tox. 4
247-161-5
25646-71-3
Acute Tox. 4; Skin Sens. 1
UM-229
407-070-5
142859-67-4
Skin Sens. 1
425-650-6
171887-03-9
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
UC-129
403-790-9
108673-51-4
Skin Sens. 1
TSD-40
413-200-1
129604-78-0
Skin Sens. 1
211-952-3
719-96-0
Skin Irrit. 2
213-103-2
924-42-5
Carc. 1B; Muta. 1B; STOT RE 1
NOP; SURFADONE LP-100 SURFACTANT
403-700-8
2687-94-7
Skin Corr. 1B
205-223-9
135-88-6
Carc. 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
BTAD
416-470-9
170292-97-4
Eye Irrit. 2
430-360-8
84793-24-8
Eye Dam. 1; Skin Sens. 1
DISPERSOL BLUE C-4G COLOUR; SUBSTANCE H87919
416-860-9
777891-21-1
Repr. 2; Skin Sens. 1
DS 100
415-060-7
1379678-87-1
Eye Dam. 1; Skin Sens. 1
423-530-8
152828-23-4
STOT RE 1; Acute Tox. 4
BENZANILID-DISPERSE-INTERMEDIATE ZP 9955
411-590-8
70693-57-1
Skin Corr. 1B
427-880-2
90357-53-2
STOT RE 2
424-550-1
84245-12-5
Carc. 1B; Muta. 1B; Repr. 1B
429-120-5
208535-04-0
Eye Dam. 1
425-300-2
186450-73-7
Skin Sens. 1
204-658-1
123-86-4
Flam. Liq. 3; STOT SE 3
205-480-7
141-32-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
202-615-1
97-88-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
209-669-5
590-01-2
Flam. Liq. 3
EP 389
407-730-2
104958-67-0
Eye Irrit. 2; Skin Sens. 1
DISPERSOL YELLOW XF
407-970-8
75511-91-0
Skin Sens. 1
203-700-6
109-74-0
Flam. Liq. 2; Acute Tox. 3
200-652-8
67-43-6
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
PREVENTOL VP OC 3061
423-990-1
149118-66-1
Acute Tox. 4; Eye Dam. 1
202-411-2
95-33-0
Skin Sens. 1
DIMETHYLPAPAMIDOLAURDIMONIUM TOSYLATE
421-130-8
156679-41-3
Eye Dam. 1; Skin Sens. 1
220-250-6
2687-91-4
Repr. 1B
437-720-3
227085-51-0
Eye Dam. 1
CATALYST 4017
407-780-5
4186-71-4
Acute Tox. 4
203-135-5
103-69-5
Acute Tox. 3; STOT RE 2
DTBA
401-980-6
-
Skin Irrit. 2; Skin Sens. 1
203-777-6
110-54-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
N-HEXYLLITHIUM
404-950-0
21369-64-2
Water-react. 1; Pyr. Sol. 1; Skin Corr. 1A
202-969-7
101-72-4
Acute Tox. 4; Skin Sens. 1
212-828-1
872-50-4
Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
yes
N-METHYL-4-(P-FORMYLSTYRYL)-PYRIDINIUM METHYLSULFATE; SBQ; SBQ-SALZ
418-240-3
74401-04-0
Skin Sens. 1

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