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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 30 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
thallium
231-138-1
7440-28-0
Acute Tox. 2; STOT RE 2
tetrasodium ethylene diamine tetraacetate
200-573-9
64-02-8
Acute Tox. 4; Eye Dam. 1
tetrasodium dihydrogen 1,1''-dihydroxy-8,8''-[p-phenylbis(imino-{6-[4-(2-aminoethyl)piperazin-1-yl]}-1,3,5-triazine-4,2-diyl-imino)]bis(2,2'-azonaphthalene-1',3,6-trisulfonate)
RED ULK 1640
420-350-1
172277-97-3
Eye Dam. 1
tetrasodium [7-(2,5-dihydroxy-KO2-7-sulfonato-6-[4-(2,5,6-trichloro-pyrimidin-4-ylamino)phenylazo]-(N1,N7-N)1-naphthylazo)-8-hydroxy-KO8-naphthalene-1,3,5-trisulfonato(6)]cuprate(II)
NAVY 14 05 711
411-470-5
141048-13-7
Skin Sens. 1
tetrasodium 5-benzamido-3-(5-(4-fluoro-6-(1-sulphonato-2-naphthylamino)-1,3,5-triazin-2-ylamino)-2-sulphonatophenylazo)-4-hydroxynaphthalene-2,7-disulphonate
C.I. REACTIVE RED 220; CIBACRON-RED F-2G; CIBACRON-ROT F-2G; REACTIVE RED 220; ROSSO REATTIVO 220; ROUGE REACTIF 220
400-790-0
85665-97-0
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
tetrasodium 5-[4-chloro-6-(N-ethyl-anilino)-1,3,5-triazin-2-ylamino]-4-hydroxy-3-(1,5-disulfonatonaphthalen-2-ylazo)-naphthalene-2,7-disulfonate
REACTIVE RED SR 6947; ROUGE REACTIF SR 6947
411-540-5
130201-57-9
Eye Dam. 1; Skin Sens. 1
tetrasodium 5-(4,6-dichloro-5-cyanopyrimidin-2-ylamino)-4-hydroxy-2,3-azodinaphthalene-1,2,5,7-disulphonate
C.I. REACTIVE RED 219
400-130-1
149057-72-7
Resp. Sens. 1
tetrasodium 4-hydroxy-5-[4-[3-(2-sulfatoethanesulfonyl)phenylamino]-6-morpholin-4-yl-1,3,5-triazin-2-ylamino]-3-(1-sulfonatonaphthalen-2-ylazo)naphthalene-2,7-disulfonate
REACTIVE RED 202 (ESTER)
413-070-6
1379676-82-0
Skin Sens. 1
tetrasodium 4-amino-5-hydroxy-6-(4-(2-(2-(sulfonatooxy)ethylsulfonyl)ethylcarbamoyl)phenylazo)-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
BLEU REACTIF 238; BLEU REATTIVO 238; C.I. REACTIVE BLUE 238; DISAZO MARINE TZ 2646; MARINE DIAZO TZ 2646; REACTIVE BLUE 238
404-320-5
116889-78-2
Skin Sens. 1
tetrasodium 4-amino-3,6-bis(5-(6-chloro-4-(2-hydroxyethylamino)-1,3,5-triazin-2-ylamino)-2-sulfonatophenylazo)-5-hydroxynaphthalene-2,7-sulfonate (containing > 35 % sodium chloride and sodium acetate)
BLEU MARINE DRIMARENE X-GN PKT; BLEU MARINE X-VT 4046; DRIMAREN MARINEBLAU X-GN PKT; DRIMAREN NAVY X-GN PKT; NAVY BLUE X-VT 4046
400-510-7
85665-98-1
Eye Dam. 1; Skin Sens. 1
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