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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 14 June 2024. Database contains 4753 unique substances/entries.
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234-329-8
11103-86-9
yes
212-736-1
865-33-8
Self-heat. 1; Skin Corr. 1B
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
245-387-9
23031-36-9
Acute Tox. 3; Acute Tox. 4
266-994-5
67747-09-5
Acute Tox. 4
255-255-2
41198-08-7
Acute Tox. 4
247-656-6
26399-36-0
Eye Irrit. 2
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
201-176-3
79-09-4
Skin Corr. 1B
204-638-2
123-62-6
Skin Corr. 1B
201-170-0
79-03-8
Flam. Liq. 2; 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
200-879-2
75-56-9
Flam. Liq. 1; Carc. 1B; Muta. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
yes
201-155-9
78-90-0
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
245-951-4
23950-58-5
Carc. 2
232-966-6
9068-59-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
218-893-2
2275-18-5
Acute Tox. 1; Acute Tox. 2
205-443-5
140-93-2
Acute Tox. 4; Skin Irrit. 2
236-656-1
13457-18-6
Acute Tox. 4
204-927-3
129-00-0
yes
259-686-7
55512-33-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
203-809-9
110-86-1
Flam. Liq. 2; Acute Tox. 4
The complex combination of polyalkylated pyridines derived from coal tar distillation or as high-boiling distillates approximately above 150°C (302°F) from the reaction of ammonia with acetaldehyde, formaldehyde or paraformaldehyde.
269-929-9
68391-11-7
Carc. 1B; Muta. 1B
236-671-3
13463-41-7
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
232-382-1
8012-00-8
yes
201-762-9
87-66-1
Muta. 2; Acute Tox. 4

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