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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 17 May 2024. Database contains 4753 unique substances/entries.
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215-181-3
1310-58-3
Acute Tox. 4; Skin Corr. 1A
234-329-8
11103-86-9
yes
FEKPDTA; KFEPDTA
405-680-6
148434-01-9
Self-heat. 2
EURELYT
400-040-2
12091-08-6
Flam. Sol. 1; Water-react. 1; Skin Corr. 1A; Acute Tox. 4
D(-) VALINE DANE SALT
427-240-2
134841-35-3
Skin Sens. 1
POTASSIUM N-(4-FLUOROPHENYL)GLYCINATE
415-710-1
184637-63-6
STOT RE 2; Eye Dam. 1; Skin Sens. 1
C.I. REACTIVE YELLOW 138:1
403-810-6
140876-13-7
Eye Dam. 1
SUMIFIX BRILLIANTBLAU GL KONZENTRAT
414-100-0
154336-20-6
Eye Dam. 1
432-240-0
12056-51-8
Carc. 2
ORANGE DER 8068
422-980-2
187026-95-5
Eye Dam. 1
604-105-8
139001-49-3
Carc. 2; Repr. 2; Skin Sens. 1
203-471-2
107-19-7
Flam. Liq. 3; Acute Tox. 3; Skin Corr. 1B
217-638-2
1918-16-7
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
204-623-0
123-38-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
205-359-9
139-40-2
Carc. 2
204-062-1
115-07-1
Flam. Gas 1; Press. Gas
204-638-2
123-62-6
Skin Corr. 1B
204-043-8
114-26-1
Acute Tox. 3
204-498-2
121-79-9
Acute Tox. 4; Skin Sens. 1
203-686-1
109-60-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-687-7
109-61-5
Flam. Liq. 2; Acute Tox. 3; Skin Corr. 1B
203-798-0
110-74-7
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-389-7
106-36-5
Flam. Liq. 3; Acute Tox. 4
203-132-9
103-65-1
Flam. Liq. 3; Asp. Tox. 1; STOT SE 3
203-572-1
108-32-7
Eye Irrit. 2
606-168-7
189278-12-4
Carc. 2
205-443-5
140-93-2
Acute Tox. 4; Skin Irrit. 2
602-927-1
123312-89-0
Carc. 2; Repr. 2
605-747-1
175013-18-0
Acute Tox. 3; Skin Irrit. 2
236-656-1
13457-18-6
Acute Tox. 4
-
108-34-9
Acute Tox. 2; Acute Tox. 1
204-927-3
129-00-0
yes
203-809-9
110-86-1
Flam. Liq. 2; Acute Tox. 4
236-671-3
13463-41-7
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1
237-031-6
13593-03-8
Acute Tox. 3; Acute Tox. 4
205-711-1
148-24-3
Repr. 1B; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
602-997-3
124495-18-7
Skin Sens. 1
PANTERA; QUIZALOFOP-P-TEFURYL
414-200-4
119738-06-6
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2
LATEMUL S-180 A
410-540-2
116726-92-2
Skin Irrit. 2; Skin Sens. 1
604-398-2
144171-61-9
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
C.I. DIRECT YELLOW 166; DIRECT YELLOW 166; GIALLO DIRETTO 166; JAUNE DIRECT 166; MONOAZO YELLOW MA 2822
403-410-1
114565-65-0
Skin Sens. 1
413-720-9
117933-89-8
yes
413-720-9
117933-89-8
yes
CARTASOL RED K-2BN; RED 10 25 501
408-000-6
118658-98-3
STOT RE 2; Skin Sens. 1
PROJET 780 NP; SUBSTANCE SC101756
407-700-9
101408-30-4
Skin Sens. 1
C.I. DIRECT BLACK 174
400-570-4
162994-84-5
Eye Irrit. 2
PS-6 SENSITIZER
413-840-1
121870-66-4
Self-react. C
1-DODECENE DIMER, HYDROGENATED; ALKANE 2
417-060-2
151006-61-0
Acute Tox. 4
MCP 968
410-190-0
132983-41-6
Eye Irrit. 2
ROBAC AS/100
403-030-6
137398-54-0
Acute Tox. 4; Skin Sens. 1

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