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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 04 March 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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gamma-hexabromocyclododecane EC / List no: 603-804-5 | CAS no: 134237-52-8
1,2,5,6,9,10-hexabromocyclodecane EC / List no: 221-695-9 | CAS no: 3194-55-6
Hexabromocyclododecane EC / List no: 247-148-4 | CAS no: 25637-99-4
beta-hexabromocyclododecane EC / List no: 603-802-4 | CAS no: 134237-51-7
alpha-hexabromocyclododecane EC / List no: 603-801-9 | CAS no: 134237-50-6
247-148-4
25637-99-4
Repr. 2; Lact.
yes
204-129-5
116-16-5
Acute Tox. 4
204-273-9
118-74-1
Carc. 1B; STOT RE 1
201-029-3
77-47-4
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
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Chloroplatinic acid hexahydrate EC / List no: 629-612-1 | CAS no: 18497-13-7
Disodium hexachloroplatinate EC / List no: 240-983-5 | CAS no: 16923-58-3
Natriumchloroplatinat EC / List no: 626-326-9 | CAS no: 19583-77-8
Diammonium hexachloroplatinate EC / List no: 240-973-0 | CAS no: 16919-58-7
Dicesium hexachloroplatinate EC / List no: 240-945-8 | CAS no: 16902-25-3
Hexachloroplatinate(2-) EC / List no: - | CAS no: 16871-54-8
Dipotassium hexachloroplatinate EC / List no: 240-979-3 | CAS no: 16921-30-5
Bis(benzyltrimethylammonium) hexachloroplatinate(2-) EC / List no: 255-585-7 | CAS no: 41909-89-1
Hexachloroplatinic acid EC / List no: 241-010-7 | CAS no: 16941-12-1
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Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
241-010-7
16941-12-1
Acute Tox. 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
HEXACONAZOLE
413-050-7
79983-71-4
Acute Tox. 4; Skin Sens. 1
204-127-4
116-15-4
Press. Gas; Acute Tox. 4; STOT SE 3
256-356-4
48122-14-1
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
260-566-1
57110-29-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
243-072-0
19438-60-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
AMINAZA TOLFAMATATE
418-350-1
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Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
247-094-1
25550-51-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
DIRECT RED 227, TETRAMETHYLAMMONIUM SALT
405-160-9
124537-30-0
Acute Tox. 3; Skin Sens. 1
235-921-9
13048-33-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
212-485-8
822-06-0
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
204-679-6
124-09-4
Acute Tox. 4; STOT SE 3; Skin Corr. 1B
211-653-8
680-31-9
Carc. 1B; Muta. 1B
203-852-3
111-27-3
Acute Tox. 4
209-731-1
591-78-6
Flam. Liq. 3; Repr. 2; STOT RE 1; STOT SE 3
203-523-4
107-83-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
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Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
247-143-7
25637-27-8
Acute Tox. 4
PROCION EMERALD H-EXL COLOUR; SUBSTANCE S156718
417-250-5
151436-99-6
Eye Dam. 1; Skin Sens. 1
BRIGHTENER SM 1018 CONC.; LEUCOPHOR BCR
405-280-1
76508-02-6
Eye Irrit. 2
RED SF-PE 3534
410-180-6
157627-99-1
Eye Dam. 1
C.I. BLEU REACTIF 204; C.I. REACTIVE BLUE 204; REACTIVE BLUE 204; REAKTIV BLAU 204
400-050-7
85153-92-0
Resp. Sens. 1; Skin Sens. 1
BRUN REACTIF 45; BRUNO REATTIVO 45; C.I. REACTIVE BROWN 45; CIBACROM BROWN 1347; CIBACRON BROWN 1347; REACTIVE BRAUN 45
401-650-1
85665-96-9
Skin Sens. 1
NATRIUMMETAWOLFRAMAT
412-770-9
12141-67-2
Acute Tox. 4; Eye Dam. 1
257-074-4
51235-04-2
Acute Tox. 4; Eye Irrit. 2
219-698-5
2499-95-8
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
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F Fungi
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F Fungi
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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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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.
-
-
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.
-
-
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.
-
-
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.
-
-
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.
-
-
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.
-
-
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.
206-114-9
302-01-2
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
STABO-FIX
405-030-1
148434-03-1
Carc. 1B; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
616-584-0
7803-57-8
yes
HNF; HYDRAZINIUM NITROFORMATE
414-850-9
4682-01-3
Expl. 1.1; Self-react. A; Carc. 1B; Acute Tox. 3; Skin Sens. 1
204-563-5
122-66-7
Carc. 1B; Acute Tox. 4
233-109-9
10034-85-2
Press. Gas; Skin Corr. 1A
233-109-9
10034-85-2
Skin Corr. 1B
233-113-0
10035-10-6
Press. Gas; Skin Corr. 1A; STOT SE 3

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