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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 26 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
naled (ISO); 1,2-dibromo-2,2-dichloroethyl dimethyl phosphate
206-098-3
300-76-5
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
nickel bis(4-cyclohexylbutyrate)
223-463-2
3906-55-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
nickel bis(benzenesulfonate)
254-642-3
39819-65-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
nickel carbonate; basic nickel carbonate; carbonic acid, nickel (2+) salt
222-068-2
3333-67-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
nickel di(acetate)
206-761-7
373-02-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
nickel diformate
222-101-0
3349-06-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
nickel phosphinate
252-840-4
36026-88-7
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
nickel silicate (3:4)
250-788-7
31748-25-1
Carc. 1A; STOT RE 1; Skin Sens. 1
nickel(II) propionate
222-102-6
3349-08-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
nonadecafluorodecanoic acid
206-400-3
335-76-2
Carc. 2; Repr. 1B; Lact.
yes
O,O,O',O'-tetrapropyl dithiopyrophosphate
221-817-0
3244-90-4
Acute Tox. 4
oxadiargyl (ISO); 3-[2,4-dichloro-5-(2-propynyloxy)phenyl]-5-(1,1-dimethylethyl)-1,3,4-oxadiazol-2(3H)-one
254-637-6
39807-15-3
Repr. 2; STOT RE 2
oxydemeton-methyl; S-2-(ethylsulphinyl)ethyl O,O-dimethyl phosphorothioate
206-110-7
301-12-2
Acute Tox. 3
p-(1,1-dimethylheptyl)phenol
250-339-5
30784-30-6
yes
pentaerythritol triacrylate
222-540-8
3524-68-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
pentanol isomers, with the exception of those specified elsewhere in this Annex
250-378-8
30899-19-5
Flam. Liq. 3; Acute Tox. 4; STOT SE 3
pentasodium N-[5-[[4-[[3-[(aminocarbonyl)amino]-4-[(3,6,8-trisulfonatonaphthalen-2-yl)azo]phenyl]amino]-6-chloro-1,3,5-triazin-2-yl]amino]-2-sulfonato-4-[[4-[[-2-(oxysulfonato)ethyl] sulfonyl]phenyl]azo]phenyl]-3-aminopropanoic acid
442-030-0
321912-47-4
Eye Dam. 1
perfluidone (ISO); 1,1,1-trifluoro-N-(4-phenylsulphonyl-o-tolyl)methanesulphonamide
253-718-3
37924-13-3
Acute Tox. 4; Eye Irrit. 2
Perfluorobutane sulfonic acid; PFBS
206-793-1
375-73-5
yes
Perfluorohexane-1-sulphonic acid
206-587-1
355-46-4
yes
perfluorononan-1-oic acid
206-801-3
375-95-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
perfluorooctanoic acid
206-397-9
335-67-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
Phenol, 4-nonyl-, phosphite (3:1)
608-492-4
3050-88-2
yes
polyhexamethylene biguanide hydrochloride; PHMB
608-723-9
32289-58-0
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
potassium chlorate
223-289-7
3811-04-9
Ox. Sol. 1; Acute Tox. 4
Potassium perfluorohexane-1-sulphonate
223-393-2
3871-99-6
yes
potassium polysulphides
253-390-1
37199-66-9
Skin Corr. 1B
proteases with the exception of those specified elsewhere in this Annex
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Proteinase, Bacillus licheniformis serine EC / List no: 279-361-3 | CAS no: 79986-26-8
Proteinase, Bothrops atrox serine EC / List no: 232-918-4 | CAS no: 9039-61-6
Proteinase, Bacillus subtilis serine EC / List no: 266-557-9 | CAS no: 67051-83-6
Proteinase, oryzin EC / List no: 232-992-8 | CAS no: 9081-30-5
Thrombin EC / List no: 232-648-7 | CAS no: 9002-04-4
Proteinase, Bacillus alcalophilus serine EC / List no: 306-090-0 | CAS no: 95979-76-3
Proteinase, Bacillus polymyxa neutral EC / List no: 255-914-4 | CAS no: 42613-33-2
Proteinase, microbial alkaline EC / List no: 256-863-0 | CAS no: 50936-53-3
Proteinase, Aspergillus niger neutral EC / List no: 254-422-7 | CAS no: 39346-39-9
Proteinase, Bacillus subtilis EC / List no: 257-520-8 | CAS no: 51931-23-8
Proteinase, Aspergillus acid EC / List no: 232-796-2 | CAS no: 9025-49-4
Proteinase, submandibular gland serine, A EC / List no: 279-893-6 | CAS no: 82047-85-6
Proteinase, serine EC / List no: 253-431-3 | CAS no: 37259-58-8
Proteinase, microbial neutral EC / List no: 232-966-6 | CAS no: 9068-59-1
Proteinase, Staphylococcus aureus serine EC / List no: 259-611-8 | CAS no: 55354-32-0
Proteinase, Aspergillus neutral EC / List no: 278-588-5 | CAS no: 77000-13-6
Proteinase, Aspergillus parasiticus neutral EC / List no: 254-418-5 | CAS no: 39335-09-6
Proteinase, Myxobacter α-lytic EC / List no: 253-448-6 | CAS no: 37288-76-9
Proteinase, Aspergillus melleus, semialkaline EC / List no: - | CAS no: 76106-83-7
Proteinase, Bacillus neutral EC / List no: 278-547-1 | CAS no: 76774-43-1
Proteinase, Bacillus alkaline EC / List no: 232-972-9 | CAS no: 9073-77-2
Proteinase, Bacillus subtilis, sutilain EC / List no: 235-390-3 | CAS no: 12211-28-8
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Proteinase, rhizopus acid EC / List no: 812-486-9 | CAS no: 9074-09-3
Proteinase, Myxobacter AL-1, II EC / List no: 276-716-4 | CAS no: 72561-05-8
Aspergillin M EC / List no: - | CAS no: 42615-60-1
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Bacillus megaterium protease fermentation product EC / List no: - | CAS no: 68909-17-1
Proteinase, Endothia aspartic EC / List no: 253-395-9 | CAS no: 37205-60-0
Proteinase, bacterial E 30 serine EC / List no: - | CAS no: 39369-34-1
Proteinase, Agkistrodon serine EC / List no: 232-933-6 | CAS no: 9046-56-4
Proteinase, microbial acid EC / List no: 256-862-5 | CAS no: 50936-52-2
Proteinase, Serratia extracellular EC / List no: 253-457-5 | CAS no: 37312-62-2
Amylase, mixed with proteinase, Bacillus thuringiensis-fermented EC / List no: - | CAS no: 68909-36-4
Myxobacteralphalyticproteinase EC / List no: - | CAS no: 12585-31-8
Proteinase, pancreatic EC / List no: 232-626-7 | CAS no: 9001-72-3
Proteinase, serine (Tritirachium album) EC / List no: 686-165-5 | CAS no: 102925-54-2
Proteinase, Streptomyces griseus EC / List no: 232-909-5 | CAS no: 9036-06-0
Proteinase, Aspergillus oryzae neutral EC / List no: 232-990-7 | CAS no: 9080-55-1
Proteinase, Aspergillus alkaline EC / List no: 232-977-6 | CAS no: 9074-07-1
Proteinase, Bacillus subtilis metallo- EC / List no: 232-991-2 | CAS no: 9080-56-2
Proteinase, aspartic EC / List no: 278-856-1 | CAS no: 78169-47-8
Proteinase, Tritirachium album serine EC / List no: 254-457-8 | CAS no: 39450-01-6
Proteinase, Mucor aspartic EC / List no: 232-975-5 | CAS no: 9073-79-4
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
934-013-6
39450-01-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
reaction mass of: 2,2'-bis(tert-pentylperoxy)-p-diisopropylbenzene; 2,2'-bis(tert-pentylperoxy)-m-diisopropylbenzene
PEROXIMON 180
412-140-3
32144-25-5
Org. Perox. D
Reaction mass of: 3,7,11-trimethyl-cis-6,10-dodecadienal; 3,7,11-trimethyl-trans-6,10-dodecadienal
425-910-9
32480-08-3
Skin Irrit. 2
reaction mass of: pentasodium; 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}naphthalene-2,7-disulfonate; tetrasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate; tetrasodium 4-amino-5-hydroxy-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-3-[(E)-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate; trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate; trisodium 4-amino-5-hydroxy-3-[(2-hydroxyethylsulfonyl)-phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate; trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[-2-sulfonato-4-(2-hydroxyethylsulfonyl)phenylazo]naphthalene-2,7-disulfonate
445-280-9
371921-40-3
Eye Dam. 1; Skin Sens. 1
salts of benzidine
252-984-8
36341-27-2
Carc. 1A; Acute Tox. 4
silicic acid, nickel salt
253-461-7
37321-15-6
Carc. 1A; STOT RE 1; Skin Sens. 1
Silicon carbide, fibrous
-
308076-74-6
Carc. 1B
sodium 2-anilino-5-(2-nitro-4-(N-phenylsulfamoyl))anilinobenzenesulfonate
NSGBB; YELLOW BROWN E-GLN
412-320-1
31361-99-6
Eye Dam. 1
sodium 2-ethylhexanolate
NA-2-ETHYLHEXANOLAT
406-150-7
38411-13-1
Flam. Sol. 1; Skin Corr. 1B
sodium nonadecafluorodecanoate
-
3830-45-3
Carc. 2; Repr. 1B; Lact.
yes
sodium salt of chloroacetic acid; sodium chloroacetate
223-498-3
3926-62-3
Acute Tox. 3; Skin Irrit. 2
sulfotep (ISO); O, O,O, O-tetraethyl dithiopyrophosphate
222-995-2
3689-24-5
Acute Tox. 1; Acute Tox. 2
tebuthiuron (ISO); 1-(5-tert-butyl-1,3,4-thiadiazol-2-yl)-1,3-dimethylurea
251-793-7
34014-18-1
Acute Tox. 4
tembotrione (ISO); 2-{2- chloro-4-(methylsulfonyl)-3- [(2,2,2-trifluoroethoxy)methyl] benzoyl}cyclohexane-1,3-dione
608-879-8
335104-84-2
Repr. 2; STOT RE 2; Skin Sens. 1
terbumeton (ISO);2-tert-butylamino-4-ethylamino-6-methoxy-1,3,5-triazine
251-637-8
33693-04-8
Acute Tox. 4
tert-butyl (5S,6R,7R)-3-bromomethyl-5,8-dioxo-7-(2-(2-phenylacetamido)-5-thia-1-azabicyclo[4.2.0] oct-2-ene-2-carboxylate
3-BMC
407-620-4
33610-13-8
Resp. Sens. 1; Skin Sens. 1
tert-butyl (triphenylphosphoranylidene) acetate
1,1-DIMETHYLETHOXY-CARBONYL-METHYLEN-TRIPHENYLPHOSPHORAN; DMY; PHOSPHORANE
412-880-7
35000-38-5
Acute Tox. 3; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
tert-butyl α, α-dimethylbenzyl peroxide
222-389-8
3457-61-2
Org. Perox. E; Skin Irrit. 2
tetrahydro-4-methylphthalicanhydride
251-823-9
34090-76-1
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
tetrasodium 4,4'-bis{4-[4-(2-hydroxyethylamino)-6-(4-sulfonatoanilino)-1,3,5-triazin-2-ylamino]phenylazo}stilbene-2,2'-disulfonate
429-230-3
371921-41-4
Eye Dam. 1
thallium thiocyanate
222-571-7
3535-84-0
Acute Tox. 2; Acute Tox. 4; STOT RE 2
thiofanox (ISO); 3,3-dimethyl-1-(methylthio)butanone-O-(N-methylcarbamoyl)oxime
254-346-4
39196-18-4
Acute Tox. 1; Acute Tox. 2
titanium(4+) oxalate
TITANYL OXALAAT
403-260-7
31363-92-5
Eye Dam. 1
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