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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 21 May 2024. Database contains 4753 unique substances/entries.
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209-676-3
590-28-3
Acute Tox. 4
231-906-6
7778-50-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
213-029-0
917-58-8
Self-heat. 1; Skin Corr. 1B
430-010-4
12160-44-0
Skin Corr. 1B; Skin Sens. 1
232-151-5
7789-23-3
Acute Tox. 3
231-594-1
7646-93-7
Skin Corr. 1B; STOT SE 3
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
212-736-1
865-33-8
Self-heat. 1; Skin Corr. 1B
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
POTASSIUM-P-TOLYLSULFIMIDE
406-650-5
97888-41-0
Eye Dam. 1
231-832-4
7758-09-0
Ox. Sol. 2; Acute Tox. 3
231-911-3
7778-73-6
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
231-912-9
7778-74-7
Ox. Sol. 1; Acute Tox. 4
223-393-2
3871-99-6
yes
220-527-1
2795-39-3
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
231-760-3
7722-64-7
Ox. Sol. 2; Repr. 2; Acute Tox. 4
253-390-1
37199-66-9
Skin Corr. 1B
-
5787-96-2
Acute Tox. 3; STOT RE 2
C.I. REACTIVE YELLOW 138:1
403-810-6
140876-13-7
Eye Dam. 1
REAKTIVROT 2713
412-490-7
-
Skin Sens. 1
C.I. REACTIVE RED 231
402-150-6
-
Eye Irrit. 2; Skin Sens. 1
SUMIFIX BRILLIANTBLAU GL KONZENTRAT
414-100-0
154336-20-6
Eye Dam. 1
425-830-4
-
Eye Dam. 1
432-240-0
12056-51-8
Carc. 2
ORANGE DER 8068
422-980-2
187026-95-5
Eye Dam. 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.
245-387-9
23031-36-9
Acute Tox. 3; Acute Tox. 4
-
-
B Bacteria and similar species
266-994-5
67747-09-5
Acute Tox. 4
BROWN JR 547
419-260-5
-
Eye Dam. 1
425-740-5
-
Eye Dam. 1
255-255-2
41198-08-7
Acute Tox. 4
247-656-6
26399-36-0
Eye Irrit. 2
604-105-8
139001-49-3
Carc. 2; Repr. 2; Skin Sens. 1
220-113-0
2631-37-0
Acute Tox. 3
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
200-746-9
71-23-8
Flam. Liq. 2; Eye Dam. 1; STOT SE 3
200-661-7
67-63-0
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
204-623-0
123-38-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-827-9
74-98-6
Flam. Gas 1; Press. Gas
211-914-6
709-98-8
Acute Tox. 4
219-006-1
2312-35-8
Carc. 2; Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1
205-359-9
139-40-2
Carc. 2
204-062-1
115-07-1
Flam. Gas 1; Press. Gas
262-104-4
60207-90-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1

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