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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 24 May 2024. Database contains 4753 unique substances/entries.
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LU20
405-450-5
66531-87-1
Skin Sens. 1
247-852-1
26628-22-8
Acute Tox. 2
RED ULK 1324
416-280-6
156769-97-0
Skin Sens. 1
DIRECT BLUE CA 36133
412-730-0
150522-10-4
Skin Corr. 1B
COBRATEC 435
404-450-2
118685-34-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
263-560-7
62476-59-9
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
OCTAMER
417-550-6
168151-92-6
Skin Sens. 1
425-460-3
1379676-84-2
Skin Sens. 1
BISULPHITE ADDUCT; GR59658A
406-190-5
54322-20-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
ORANGE JOG 365
416-370-5
156738-27-1
Skin Sens. 1
ACID YELLOW HT 2803; MONOAZO YELLOW HT 2803
407-800-2
136213-75-7
Skin Sens. 1
ACTIZONE; PG 85; PHENOLESTER C; PHENOLESTER C/S
400-030-8
94612-91-6
Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1
204-857-3
127-68-4
Eye Irrit. 2; Skin Sens. 1
-
4312-97-4
Acute Tox. 4
ACETESSIG-KRESIDINSULFOSÄURES NATRIUMSALZ
411-680-7
133167-77-8
Skin Sens. 1
418-410-7
139122-78-4
Eye Irrit. 2
BENZTRIAZOL UV ABSORBER BUK 4499; BUK 4499; UV ABSORBER BUK 4499
403-080-9
92484-48-5
Eye Dam. 1
YELLOW E-JD 3442
410-150-2
147703-65-9
Skin Sens. 1
H: SÄUREGELB 2829
401-870-8
115035-41-1
Eye Dam. 1
AF-390
407-720-8
155160-86-4
Skin Sens. 1
AF-365
405-510-0
121216-78-2
Skin Irrit. 2; Skin Sens. 1
NA-2-ETHYLHEXANOLAT
406-150-7
38411-13-1
Flam. Sol. 1; Skin Corr. 1B
205-055-6
132-27-4
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
BENZOYL BISULFITE
410-680-4
1379676-76-2
Skin Sens. 1
NSGBB; YELLOW BROWN E-GLN
412-320-1
31361-99-6
Eye Dam. 1
430-890-1
81992-66-7
Skin Sens. 1
434-360-9
91125-43-8
Eye Dam. 1; Skin Sens. 1
FAT 40'436; FAT 40'436/A; REACTIVE ORANGE TZ 3538
410-770-3
146177-84-6
Skin Sens. 1
224-580-1
4418-26-2
Acute Tox. 4
REACTIVE ORANGE TZ 3931
413-990-8
149850-31-7
Skin Sens. 1
422-100-7
102061-82-5
Eye Dam. 1; Skin Sens. 1
420-800-7
1379804-37-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
DUPLOSAN-DP-NATRIUM; DUPOLSON-DP-NATRIUM
413-340-3
119299-10-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
EURESYNTH(R) 5010
418-720-2
-
Flam. Sol. 1; Water-react. 1; Pyr. Sol. 1; Acute Tox. 4; Skin Corr. 1A
426-520-1
71420-85-4
Skin Sens. 1
SÄUREBRAUN 6230
401-220-3
-
Acute Tox. 4
LEVAFIX GELB FC 47859; REACTIVE YELLOW FC 47859
413-470-0
134595-59-8
Skin Sens. 1
C.I. BASIC BLUE 163
407-340-2
124719-24-0
Eye Dam. 1
231-132-9
7440-23-5
Water-react. 1; Skin Corr. 1B
Product obtained from recycling of the end electrolyte of copper refining electrolysis followed by evaporation to separate the residual sulfuric acid. Consists primarily of nickel and iron sulfates with small amounts of the sulfates of zinc, alkali earths and alkali metals.
295-859-3
92129-57-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Substance obtained as a powdery cathodic precipitate during the electrolytic decoppering stage of copper refining electrolysis. Consists primarily of copper with antimony, arsenic, lead and nickel in metallic form as well as oxides and sulfates.
305-433-1
94551-87-8
Carc. 1A; Muta. 2; Repr. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
A complex combination of hydrocarbons obtained from a petroleum fraction by solvent crystallization (solvent dewaxing) or as a distillation fraction from a very waxy crude. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.
265-165-5
64742-61-6
Carc. 1B
A complex combination of hydrocarbons obtained from a petroleum fraction by solvent deparaffination. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
295-524-1
92062-10-7
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-158-5
97863-06-4
Carc. 1B
A complex combination of hydrocarbons obtained by treatment of low-melting petroleum slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
295-525-7
92062-11-8
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with bentonite for removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-156-4
97863-05-3
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of low-melting slack wax with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-155-9
97863-04-2
Carc. 1B
A complex combination of hydrocarbons obtained by treating slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.
295-523-6
92062-09-4
Carc. 1B
A complex combination of hydrocarbons obtained by treatment of a petroleum slack wax fraction with natural or modified clay in either a contacting or percolation process. It consists predominantly of saturated straight and branched hydrocarbons having carbon numbers predominantly greater than C20.
292-660-3
90669-78-6
Carc. 1B
A complex combination of hydrocarbons obtained by treatment of petroleum slack wax with activated charcoal for the removal of trace polar constituents and impurities.
309-723-9
100684-49-9
Carc. 1B

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