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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 28 March 2024. Database contains 4753 unique substances/entries.
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206-400-3
335-76-2
Carc. 2; Repr. 1B; Lact.
yes
203-931-2
112-05-0
Skin Irrit. 2; Eye Irrit. 2
246-672-0
25154-52-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
1 - 2.5 moles ethoxylated
500-209-1
68412-54-4
yes
500-024-6
9016-45-9
yes
931-755-2
-
yes
931-756-8
-
yes
931-753-1
-
yes
931-754-7
-
yes
939-993-9
-
yes
-
-
yes
938-618-6
-
yes
932-998-7
-
yes
213-589-6
991-42-4
Acute Tox. 4
-
2163-79-3
Acute Tox. 4
-
-
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.
VULKANISATIONSBESCHLEUNIGER VP KA 9124
404-380-2
110799-28-5
Skin Sens. 1
-
-
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.
ASIL-322; OS-5200
421-870-1
156145-66-3
Repr. 2; Acute Tox. 4; STOT RE 2
KENODOX
404-300-6
116753-76-5
Org. Perox. C
221-817-0
3244-90-4
Acute Tox. 4
227-534-9
5873-54-1
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
202-423-8
95-48-7
Acute Tox. 3; Skin Corr. 1B
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N,N'-(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis[3-oxobutyramide] EC / List no: 223-873-1 | CAS no: 4104-12-5
-
-
Carc. 1B
218-276-8
2104-64-5
Acute Tox. 1; Acute Tox. 2
ETA; ETA 50 (50 %IGE ZUBEREITUNG); O-ETHYLHYDROXYLAMINE
402-030-3
624-86-2
Flam. Liq. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Sens. 1
432-750-3
109202-58-6
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
434-350-4
103122-66-3
Flam. Liq. 3; Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
201-855-4
88-74-4
Acute Tox. 3; STOT RE 2
202-430-6
95-54-5
Carc. 2; Muta. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
210-418-7
615-28-1
Carc. 2; Muta. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
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N,N'-(3,3'-dimethylbiphenyl-4,4'-ylene)di(acetoacetamide) EC / List no: 202-111-1 | CAS no: 91-96-3
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-
Carc. 1B
202-429-0
95-53-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2
yes
202-422-2
95-47-6
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
204-695-3
124-30-1
Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
209-136-7
556-67-2
Repr. 2
yes
203-892-1
111-65-9
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
204-677-5
124-07-2
Skin Corr. 1C
PROCION BRILLIANT ORANGE H-EXL; S156745
412-960-1
148878-21-1
Eye Dam. 1; Skin Sens. 1
H112339
413-550-5
-
Skin Irrit. 2; Eye Dam. 1
247-761-7
26530-20-1
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1; Eye Dam. 1; Skin Sens. 1A
213-853-0
1034-01-1
Acute Tox. 4; Skin Sens. 1
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-
Skin Corr. 1A; STOT SE 3
-
-
yes
An inorganic pigment that is the reaction product of high temperature calcination in which nickel (II) oxide and silicon oxide in varying amounts are homogeneously and ionically interdiffused to form a crystalline matrix of olivine. Its composition may include any one or a combination of the modifiers alkali or alkaline earth halides.
271-112-7
68515-84-4
Carc. 1A; STOT RE 1; Skin Sens. 1
214-197-8
1113-02-6
Acute Tox. 3; Acute Tox. 4
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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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P Parasites
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P Parasites
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P Parasites

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