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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 03 May 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
potassium hydroxide; caustic potash
215-181-3
1310-58-3
Acute Tox. 4; Skin Corr. 1A
potassium iron(III) 1,3-propanediamine-N, N,N',N'-tetraacetate hemihydrate
FEKPDTA; KFEPDTA
405-680-6
148434-01-9
Self-heat. 2
potassium methanolate; potassium methoxide
212-736-1
865-33-8
Self-heat. 1; Skin Corr. 1B
potassium mu-fluoro-bis(triethylaluminium)
EURELYT
400-040-2
12091-08-6
Flam. Sol. 1; Water-react. 1; Skin Corr. 1A; Acute Tox. 4
potassium N-(1-methoxy-1-oxobut-2-en-3-yl)valinate
D(-) VALINE DANE SALT
427-240-2
134841-35-3
Skin Sens. 1
potassium N-(4-fluorophenyl)glycinate
POTASSIUM N-(4-FLUOROPHENYL)GLYCINATE
415-710-1
184637-63-6
STOT RE 2; Eye Dam. 1; Skin Sens. 1
potassium N-(4-toluenesulfonyl)-4-toluenesulfonamide
POTASSIUM-P-TOLYLSULFIMIDE
406-650-5
97888-41-0
Eye Dam. 1
potassium nitrite
231-832-4
7758-09-0
Ox. Sol. 2; Acute Tox. 3
potassium pentachlorophenolate
231-911-3
7778-73-6
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
potassium perchlorate
231-912-9
7778-74-7
Ox. Sol. 1; Acute Tox. 4
potassium perfluorooctanesulfonate; potassium heptadecafluorooctane-1-sulfonate
220-527-1
2795-39-3
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
potassium permanganate
231-760-3
7722-64-7
Ox. Sol. 2; Repr. 2; Acute Tox. 4
potassium polysulphides
253-390-1
37199-66-9
Skin Corr. 1B
potassium salt of DNOC; potassium 4,6-dinitro-o-cresolate
-
5787-96-2
Acute Tox. 3; STOT RE 2
potassium sodium 3,3'-(3(or 4)-methyl-1,2-phenylenebis(imino(6-chloro)-1,3,5-triazine-4,2-diylimino(2-acetamido-5-methoxy)-4,1-phenylenazo)dinaphthalene-1,5-disulfonate
C.I. REACTIVE YELLOW 138:1
403-810-6
140876-13-7
Eye Dam. 1
potassium sodium 4-(4-chloro-6-(3,6-disulfonato-7-(5,8-disulfonato-naphthalen-2-ylazo)-8-hydroxy-naphthalen-1-ylamino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(4-(2-sulfatoethanesulfonyl)-phenylazo)-naphthalene-1,7-disulfonate
REAKTIVROT 2713
412-490-7
-
Skin Sens. 1
potassium sodium 5-(4-chloro-6-(N-(4-(4-chloro-6-(5-hydroxy-2,7-disulphonato-6-(2-sulphonatophenylazo)-4-naphthylamino)-1,3,5-triazin-2-ylamino) phenyl-N-methyl)amino)-1,3,5-triazin-2-ylamino)-4-hydroxy-3-(2-sulphonatophenylazo)naphthalene-2,7-disulphonat
C.I. REACTIVE RED 231
402-150-6
-
Eye Irrit. 2; Skin Sens. 1
potassium sodium 6,13-dichloro-3,10-bis{2-[4-[3-(2-hydroxysulphonyloxyethanesulfonyl)phenylamino]-6-(2,5-disulfonatophenylamino)-1,3,5-triazin-2-ylamino]ethylamino}benzo[5,6][1,4]oxazino[2,3-b]phenoxazine-4,11-disulfonate
SUMIFIX BRILLIANTBLAU GL KONZENTRAT
414-100-0
154336-20-6
Eye Dam. 1
potassium tetrasodium bis[(N,N'-n)-1'-(phenylcarbamoyl)-3,5-disulfonatobenzeneazo-1'-prop-1'-ene-2,2'-diolato]chromate(III)
425-830-4
-
Eye Dam. 1
Potassium titanium oxide(K2Ti6O13)
432-240-0
12056-51-8
Carc. 2
potassium, sodium 2,4-diamino-3-[4-(2-sulfonatoethoxysulfonyl)phenylazo]-5-[4-(2-sulfonatoethoxysulfonyl)-2-sulfonatophenylazo]-benzenesulfonate
ORANGE DER 8068
422-980-2
187026-95-5
Eye Dam. 1
Powassan
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
prallethrin (ISO); ETOC; 2-methyl-4-oxo-3-(prop-2-ynyl)cyclopent-2-en-1-yl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
245-387-9
23031-36-9
Acute Tox. 3; Acute Tox. 4
Prevotella spp.
-
-
B Bacteria and similar species
prochloraz (ISO);N-propyl-N-[2-(2,4,6-trichlorop henoxy)ethyl]-1H-imidazole-1- carboxamide
266-994-5
67747-09-5
Acute Tox. 4
product by process iron complex of azo dyestuffs obtained by coupling a mixture of diazotized 2-amino-1-hydroxybenzene-4-sulfanilide and 2-amino-1-hydroxybenzene-4-sulfonamide with resorcin, the obtained mixture being subsequently submitted to a second coupling reaction with a mixture of diazotized 3-aminobenzene-1-sulfonic acid (metanilic acid) and 4'-amino-4-nitro-1,1'-diphenylamine-2-sulfonic acid and metallization with ferric chloride, sodium salt
BROWN JR 547
419-260-5
-
Eye Dam. 1
product-by-process definition polyazodyestuff obtained by coupling 4-[4-(1-amino-8-hydroxy-3,6-disulfo-2-naphthylazo)phenylsulfonylamino] benzenediazonium with reaction mass of 4-carboxybenzenediazonium and diphenylamine-3-sulfo-4,4'-bisdiazonium, and further coupling of the obtained compounds with reaction mass of naphth-2-ol and 3-aminophenol, sodium salts; sodium chloride
425-740-5
-
Eye Dam. 1
profenofos (ISO)O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate
255-255-2
41198-08-7
Acute Tox. 4
profluralin (ISO);N-(cyclopropylmethyl)-α, α,α- trifluoro-2,6-dinitro-N-propyl-p-toluidine
247-656-6
26399-36-0
Eye Irrit. 2
profoxydim (ISO); 2-{(EZ)-1-[(2RS)-2-(4-chlorophenoxy)propoxyimino]butyl}-3-hydroxy-5-(thian-3-yl)cyclohex-2-en-1-one
604-105-8
139001-49-3
Carc. 2; Repr. 2; Skin Sens. 1
promecarb (ISO); 3-isopropyl-5-methylphenyl N-methylcarbamate
220-113-0
2631-37-0
Acute Tox. 3
prop-2-yn-1-ol; propargyl alcohol
203-471-2
107-19-7
Flam. Liq. 3; Acute Tox. 3; Skin Corr. 1B
propachlor (ISO); 2-chloro-N-isopropylacetanilide; α-chloro-N-isopropylacetanilide
217-638-2
1918-16-7
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
propan-1-ol; n-propanol
200-746-9
71-23-8
Flam. Liq. 2; Eye Dam. 1; STOT SE 3
propan-2-ol; isopropyl alcohol; isopropanol
200-661-7
67-63-0
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
propanal; propionaldehyde
204-623-0
123-38-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
propane
200-827-9
74-98-6
Flam. Gas 1; Press. Gas
propanil (ISO); 3',4'-dichloropropionanilide
211-914-6
709-98-8
Acute Tox. 4
propargite (ISO); 2-(4-tert-butylphenoxy)cyclohexyl prop-2-ynyl sulphite
219-006-1
2312-35-8
Carc. 2; Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1
propazine (ISO);2-chloro-4,6-bis(isopropylamino)-1,3,5-triazine
205-359-9
139-40-2
Carc. 2
propene; propylene
204-062-1
115-07-1
Flam. Gas 1; Press. Gas
propiconazole(ISO); (2RS,4RS;2RS,4SR)-1-{[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl}-1H-1,2,4-triazole
262-104-4
60207-90-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1
propineb (ISO); polymeric zinc propylenebis(dithiocarbamate)
620-365-5
9016-72-2
Acute Tox. 4; STOT RE 2; Skin Sens. 1
propionic acid ... %
201-176-3
79-09-4
Skin Corr. 1B
propionic anhydride
204-638-2
123-62-6
Skin Corr. 1B
propionyl chloride
201-170-0
79-03-8
Flam. Liq. 2; Skin Corr. 1B
propoxur (ISO); 2-isopropyloxyphenyl N-methylcarbamate; 2-isopropoxyphenyl methylcarbamate
204-043-8
114-26-1
Acute Tox. 3
propyl 3,4,5-trihydroxybenzoate
204-498-2
121-79-9
Acute Tox. 4; Skin Sens. 1
propyl acetate
203-686-1
109-60-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
propyl chloroformate; chloroformic acid propylester; n-propyl chloroformate
203-687-7
109-61-5
Flam. Liq. 2; Acute Tox. 3; Skin Corr. 1B
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