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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 19 April 2024. Database contains 4753 unique substances/entries.
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215-217-8
1314-06-3
Carc. 1A; STOT RE 1; Skin Sens. 1
620-400-4
12031-65-1
Carc. 1A; STOT RE 1; Skin Sens. 1
-
12673-58-4
Carc. 1A; STOT RE 1; Skin Sens. 1
238-034-5
14177-55-0
Carc. 1A; STOT RE 1; Skin Sens. 1
248-169-1
27016-75-7
Carc. 1A; STOT RE 1; Skin Sens. 1
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77900.
271-853-6
68610-24-2
Carc. 1A; STOT RE 1; Skin Sens. 1
235-723-2
12619-90-8
Carc. 1A; STOT RE 1; Skin Sens. 1
234-493-0
12007-00-0
Carc. 1A; STOT RE 1; Skin Sens. 1
-
65229-23-4
Carc. 1A; STOT RE 1; Skin Sens. 1
235-103-1
12068-61-0
Carc. 1A; STOT RE 1; Skin Sens. 1
234-823-3
12035-36-8
Carc. 1A; STOT RE 1; Skin Sens. 1
235-379-3
12201-89-7
Carc. 1A; STOT RE 1; Skin Sens. 1
257-970-5
52502-12-2
Carc. 1A; STOT RE 1; Skin Sens. 1
Product of blowing smelted nickel ore in a converter to lower the iron content.
273-749-6
69012-50-6
Carc. 1A; STOT RE 1; Skin Sens. 1
215-215-7
1313-99-1
Carc. 1A; STOT RE 1; Skin Sens. 1
208-933-7
547-67-1
Carc. 1A; STOT RE 1; Skin Sens. 1
234-323-5
11099-02-8
Carc. 1A; STOT RE 1; Skin Sens. 1
215-216-2
1314-05-2
Carc. 1A; STOT RE 1; Skin Sens. 1
250-788-7
31748-25-1
Carc. 1A; STOT RE 1; Skin Sens. 1
235-260-6
12142-88-0
Carc. 1A; STOT RE 1; Skin Sens. 1
234-824-9
12035-38-0
Carc. 1A; STOT RE 1; Skin Sens. 1
235-752-0
12653-76-8
Carc. 1A; STOT RE 1; Skin Sens. 1
234-825-4
12035-39-1
Carc. 1A; STOT RE 1; Skin Sens. 1
239-876-6
15780-33-3
Carc. 1A; STOT RE 1; Skin Sens. 1
238-032-4
14177-51-6
Carc. 1A; STOT RE 1; Skin Sens. 1
274-755-1
70692-93-2
Carc. 1A; STOT RE 1; Skin Sens. 1
244-578-4
21784-78-1
Carc. 1A; STOT RE 1; Skin Sens. 1
An inorganic pigment that is the reaction product of high temperature calcination in which nickel (II) oxide and silicon oxide in varying amounts are homogeneously and ionically interdiffused to form a crystalline matrix of olivine. Its composition may include any one or a combination of the modifiers alkali or alkaline earth halides.
271-112-7
68515-84-4
Carc. 1A; STOT RE 1; Skin Sens. 1
243-867-2
20543-06-0
Carc. 1A; STOT RE 1; Skin Sens. 1
253-461-7
37321-15-6
Carc. 1A; STOT RE 1; Skin Sens. 1
235-688-3
12519-85-6
Carc. 1A; STOT RE 1; Skin Sens. 1
236-771-7
13477-70-8
Carc. 1A; STOT RE 1; Skin Sens. 1
-
74646-29-0
Carc. 1A; STOT RE 1; Skin Sens. 1
234-495-1
12007-02-2
Carc. 1A; STOT RE 1; Skin Sens. 1
-
12137-12-1
Carc. 1A; STOT RE 1; Skin Sens. 1
CARTASOL GEEL M-GL CONC.; CARTASOL GELB M-GL FLÜSSIG (ZUBEREITUNG); CARTASOL GELB M-GL KONZ.; CARTASOL YELLOW M-GL CONC.; HM 2580
401-500-5
118658-99-4
Carc. 1B
214-237-4
1116-54-7
Carc. 1B
209-474-5
581-89-5
Carc. 1B
205-057-7
132-32-1
Carc. 1B
209-321-2
569-61-9
Carc. 1B
200-453-6
60-09-3
Carc. 1B
yes
202-204-7
92-93-3
Carc. 1B
210-025-0
602-87-9
Carc. 1B
ARANCIO DISPERSO 149; C.I. DISPERSE ORANGE 149; DISPERS ORANGE 149; DISPERSE ORANGE 149; ORANGE DISPERSE 149; TERASIL GOLDGELB 2RS
400-340-3
85136-74-9
Carc. 1B
A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260°C to 290°C (500°F to 554°F).
309-851-5
101316-45-4
Carc. 1B
292-454-3
90622-53-0
Carc. 1B
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 polycyclic aromatic hydrocarbons obtained from coal tar having an approximate distillation range of 300°C to 400°C (572°F to 752°F). Composed primarily of phenanthrene, anthracene and carbazole
292-602-7
90640-80-5
Carc. 1B
yes
201-549-0
84-65-1
Carc. 1B
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

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