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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 18 April 2024. Database contains 4753 unique substances/entries.
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240-877-9
16853-85-3
Water-react. 1; Skin Corr. 1A
244-088-0
20859-73-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
231-072-3
7429-90-5
Water-react. 2; Pyr. Sol. 1
231-072-3
7429-90-5
Water-react. 2; Flam. Sol. 1
209-090-8
555-31-7
Flam. Sol. 1
212-634-7
834-12-8
Acute Tox. 4
-
919-76-6
Acute Tox. 4
262-977-1
61788-46-3
Acute Tox. 4; Asp. Tox. 1; STOT SE 3; STOT RE 2; Skin Corr. 1B
262-976-6
61788-45-2
Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
268-626-9
68131-73-7
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
268-626-9
68131-73-7
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
263-125-1
61790-33-8
Acute Tox. 4; Asp. Tox. 1; STOT RE 2; Skin Corr. 1B
217-990-7
2032-59-9
Acute Tox. 3
672-776-4
348635-87-0
Carc. 2; Eye Irrit. 2
251-375-4
33089-61-1
Acute Tox. 4; STOT RE 2; Skin Sens. 1
200-521-5
61-82-5
Repr. 2; STOT RE 2
215-647-6
1336-21-6
Skin Corr. 1B
231-635-3
7664-41-7
Flam. Gas 2; Press. Gas; Acute Tox. 3; Skin Corr. 1B
640 AMMONIUM SALT; KSMIA; S-102; SMIA
405-990-1
97148-39-5
Flam. Sol. 1
441-050-7
223705-57-5
Skin Irrit. 2; Eye Dam. 1
215-676-4
1341-49-7
Acute Tox. 3; Skin Corr. 1B
AIZEN SPILON BLACK TRH; AIZEN SPILON SCHWARZ TRH; THR-1; TRH
400-110-2
109125-51-1
Self-react. C
235-186-4
12125-02-9
Acute Tox. 4; Eye Irrit. 2
235-185-9
12125-01-8
Acute Tox. 3
232-235-1
7790-98-9
Expl. 1.1; Ox. Sol. 1
249-415-0
29081-56-9
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
232-989-1
9080-17-5
Skin Corr. 1B
221-037-0
2980-64-5
Acute Tox. 2; Acute Tox. 1; STOT RE 2
232-565-6
9000-90-2
Resp. Sens. 1
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Amylase, α- EC / List no: 232-565-6 | CAS no: 9000-90-2
Amylase EC / List no: 232-567-7 | CAS no: 9000-92-4
Amylase, gluco- EC / List no: 232-877-2 | CAS no: 9032-08-0
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Amylase, alpha-, Bacillus amyloliquefaciens EC / List no: - | CAS no: 152923-48-3
Amylase, gluco-, Rhizopus oryzae EC / List no: - | CAS no: 152923-55-2
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Amylase, fungal EC / List no: 232-742-8 | CAS no: 9013-01-8
Amylase, β- EC / List no: 232-566-1 | CAS no: 9000-91-3
Amylase, bacterial EC / List no: 232-560-9 | CAS no: 9000-85-5
Amylase, iso- EC / List no: 232-956-1 | CAS no: 9067-73-6
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Amylase, α-, Aspergillus oryzae EC / List no: 232-588-1 | CAS no: 9001-19-8
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-
Resp. Sens. 1
-
-
P Parasites
433-560-3
15375-21-0
Repr. 2
-
-
P Parasites
-
-
P Parasites
202-910-5
101-05-3
Eye Irrit. 2; Skin Irrit. 2
200-539-3
62-53-3
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Skin Sens. 1
A complex combination of hydrocarbons from the base-freed fraction obtained from the distillation of coal tar and boiling in the range of approximately 325°C to 365°C (617°F to 689°F). It contains predominantly anthracene and phenanthrene and their alkyl derivatives.
295-274-3
91995-14-1
Carc. 1B
A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous coal high temperature tar and boiling in the approximate range of 350°C to 360°C (662°F to 680°F). It contains chiefly anthracene, carbazole and phenanthrene.
295-276-4
91995-16-3
Carc. 1B; Muta. 1B
201-549-0
84-65-1
Carc. 1B
-
-
Acute Tox. 4
231-601-8
7647-18-9
Skin Corr. 1B
233-047-2
10025-91-9
Skin Corr. 1B
232-009-2
7783-56-4
Acute Tox. 3
215-175-0
1309-64-4
Carc. 2
201-706-3
86-88-4
Acute Tox. 2; Carc. 2
-
-
B Bacteria and similar species
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polyethylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-957-1
101794-75-6
Carc. 1B
A complex combination hydrocarbons obtained from mixed coal tar pitch-polyethylene-polypropylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-956-6
101794-74-5
Carc. 1B
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polystyrene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-958-7
101794-76-7
Carc. 1B
268-618-5
68131-49-7
Carc. 1B; Muta. 1B; Asp. Tox. 1

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