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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 27 May 2024. Database contains 4753 unique substances/entries.
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205-801-0
152-16-9
Acute Tox. 1; Acute Tox. 2
203-300-1
105-46-4
Flam. Liq. 2
237-732-7
13952-84-6
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
234-363-3
11120-22-2
yes
233-054-0
10026-04-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
605-752-9
175217-20-6
STOT RE 2
603-404-0
130328-20-0
Repr. 2; Skin Irrit. 2; Eye Dam. 1
204-535-2
122-34-9
Carc. 2
213-801-7
1014-70-6
Acute Tox. 4
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
C.I. BASIC BLUE 163
407-340-2
124719-24-0
Eye Dam. 1
LEVAFIX GELB FC 47859; REACTIVE YELLOW FC 47859
413-470-0
134595-59-8
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
420-800-7
1379804-37-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
422-100-7
102061-82-5
Eye Dam. 1; Skin Sens. 1
REACTIVE ORANGE TZ 3931
413-990-8
149850-31-7
Skin Sens. 1
FAT 40'436; FAT 40'436/A; REACTIVE ORANGE TZ 3538
410-770-3
146177-84-6
Skin Sens. 1
BENZOYL BISULFITE
410-680-4
1379676-76-2
Skin Sens. 1
205-055-6
132-27-4
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
AF-365
405-510-0
121216-78-2
Skin Irrit. 2; Skin Sens. 1
AF-390
407-720-8
155160-86-4
Skin Sens. 1
H: SÄUREGELB 2829
401-870-8
115035-41-1
Eye Dam. 1
YELLOW E-JD 3442
410-150-2
147703-65-9
Skin Sens. 1
418-410-7
139122-78-4
Eye Irrit. 2
ACETESSIG-KRESIDINSULFOSÄURES NATRIUMSALZ
411-680-7
133167-77-8
Skin Sens. 1
204-857-3
127-68-4
Eye Irrit. 2; Skin Sens. 1
ACID YELLOW HT 2803; MONOAZO YELLOW HT 2803
407-800-2
136213-75-7
Skin Sens. 1
ORANGE JOG 365
416-370-5
156738-27-1
Skin Sens. 1
425-460-3
1379676-84-2
Skin Sens. 1
OCTAMER
417-550-6
168151-92-6
Skin Sens. 1
COBRATEC 435
404-450-2
118685-34-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
DIRECT BLUE CA 36133
412-730-0
150522-10-4
Skin Corr. 1B
RED ULK 1324
416-280-6
156769-97-0
Skin Sens. 1
215-608-3
1333-83-1
Acute Tox. 3; Skin Corr. 1B
234-190-3
10588-01-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
205-487-5
141-52-6
Self-heat. 1; Skin Corr. 1B
215-185-5
1310-73-2
Skin Corr. 1A
204-699-5
124-41-4
Self-heat. 1; Skin Corr. 1B
239-172-9
15120-21-5
Ox. Sol. 2; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
239-172-9
15120-21-5
yes
239-172-9
15120-21-5
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
215-209-4
1313-60-6
Ox. Sol. 1; Skin Corr. 1A
215-686-9
1344-08-7
Acute Tox. 3; Skin Corr. 1B
435-350-7
141250-43-3
Eye Dam. 1
233-267-9
10102-18-8
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
205-025-2
131-52-2
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
A complex combination of hydrocarbons obtained by the distillation of hydrocracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 235°C to 290°C (455°F to 554°F).
309-881-9
101316-80-7
Asp. Tox. 1
A complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 180°C to 240°C (356°F to 464°F).
309-882-4
101316-81-8
Asp. Tox. 1
A complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 175°C to 220°C (347°F to 428°F).
309-884-5
101316-82-9
Asp. Tox. 1
604-636-5
148477-71-8
Carc. 1B; Repr. 2; STOT RE 2; Skin Sens. 1B

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