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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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.

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Last updated 23 April 2024. Database contains 4753 unique substances/entries.
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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
1-amino-2-methyl-2-propanethiol hydrochloride
434-480-1
32047-53-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
1-amino-4-(3-[4-chloro-6-(2,5-di-sulfophenylamino)-1,3,5-triazin-2-ylamino]-2,2-dimethyl-propylamino)-anthraquinone-2-sulfonic acid, sodium/lithium salt
BLAU MUB 557
419-520-8
172890-93-6
Skin Sens. 1
1-amino-4-[(4-amino-2-sulfofenyl)amino]-9,10-dihydro-9,10-dioxo-2-anthracenesulfonic acid, disodium salt, reaction products with 2-[[3-[(4,6-dichloro-1,3,5-triazin-2-yl)ethylamino]phenyl]sulfonyl]ethyl hydrogen sulfate, sodium salts
451-430-4
500717-36-2
Eye Dam. 1; Skin Sens. 1
1-aminocyclopentanecarboxamide
422-950-9
17193-28-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1
1-aminopropan-2-ol; isopropanolamine
201-162-7
78-96-6
Skin Corr. 1B
1-benzyl-5-ethoxyimidazolidine-2,4-dione
BEH; FC-05; FCO5; WMT 1155
417-340-4
65855-02-9
Acute Tox. 4
1-benzylimidazolidine-2,4-dione
T-5914 AND 501006025007
421-340-1
6777-05-5
Acute Tox. 4
1-bromo-2-methylpropyl propionate
422-900-6
158894-67-8
Flam. Liq. 3; Carc. 2; Skin Corr. 1B; Skin Sens. 1
1-bromo-3,4,5-trifluorobenzene
1-BROM-3,4,5-TRIFLUORBENZOL; 1-BROMO-3,4,5-TRIFLUOROBENZENE
418-480-9
138526-69-9
Flam. Liq. 3; Carc. 2; Skin Irrit. 2; Eye Dam. 1
1-bromo-3,5-difluorobenzene
1-BROM-3,5-DIFLUORBENZOL; 1-BROMO-3,5-DIFLUOROBENZENE; BDFB
416-710-2
461-96-1
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
1-bromo-9-(4,4,5,5,5-pentafluoropentylthio)nonane
BROMIDE 182,780
422-850-5
148757-89-5
Skin Sens. 1
1-bromopropane; n-propyl bromide
203-445-0
106-94-5
Flam. Liq. 2; Repr. 1B; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
1-butyl-2-methylpyridinium bromide
ENS 119
402-680-8
26576-84-1
Acute Tox. 4
1-chloro-1-nitropropane
209-990-0
600-25-9
Acute Tox. 4
1-chloro-2,3-epoxypropane; epichlorhydrin
203-439-8
106-89-8
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
1-chloro-4-nitrobenzene
202-809-6
100-00-5
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 2
1-chloro-N,N-diethyl-1,1-diphenyl-1-(phenylmethyl)phosphoramine
GM 102 E
411-370-1
82857-68-9
Acute Tox. 3; Eye Dam. 1
1-chlorobutane; butyl chloride
203-696-6
109-69-3
Flam. Liq. 2
1-chloromethyl-4-fluoro-1,4-diazoniabicyclo[2.2.2]octane bis(tetrafluoroborate)
414-380-4
140681-55-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
1-chloropentane
208-846-4
543-59-9
Flam. Liq. 2; Acute Tox. 4
1-chloropropane
208-749-7
540-54-5
Flam. Liq. 2; Acute Tox. 4
1-cyclopropyl-3-(2-methylthio-4-trifluoromethylphenyl)-1,3-propanedione
421-080-7
161462-35-7
STOT RE 2
1-cyclopropyl-6,7-difluoro-1,4-dihydro-4-oxoquinoline-3-carboxylic acid
CHINOLONCARBONSÄURE 93-073; CP-70,335
413-760-7
93107-30-3
Repr. 2
1-dimethoxymethyl-2-nitro-benzene
O-NITROBENZALDEHYDDIMETHYLACETAL
423-830-9
20627-73-0
Skin Sens. 1
1-dimethylaminopropan-2-ol; dimepranol (INN)
203-556-4
108-16-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
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