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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 25 April 2024. Database contains 4753 unique substances/entries.
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203-551-7
108-11-2
Flam. Liq. 3; STOT SE 3
203-550-1
108-10-1
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
203-626-4
108-89-4
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-204-7
92-93-3
Carc. 1B
202-811-7
100-02-7
Acute Tox. 4; STOT RE 2
211-535-6
659-49-4
Acute Tox. 4
203-251-6
104-91-6
Muta. 2; Acute Tox. 4; Eye Dam. 1
202-808-0
99-99-0
Acute Tox. 3; STOT RE 2
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
-
-
yes
-
-
yes
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
POLYSTAY K; WINGSTAY K
404-160-6
164907-73-7
Skin Sens. 1
202-591-2
97-56-3
Carc. 1B; Skin Sens. 1
yes
419-240-6
171054-89-0
Eye Dam. 1
4-PHENYL-1-BUTENE; SQ 31,175; SQ31175
405-980-7
768-56-9
Skin Irrit. 2
BICH-3 STUFE 3
406-810-4
40649-36-3
Skin Irrit. 2
202-696-3
98-73-7
Repr. 1B; STOT RE 1; Acute Tox. 4
202-679-0
98-54-4
Repr. 2; Skin Irrit. 2; Eye Dam. 1
yes
621-345-9
2315-67-5
yes
202-848-9
100-40-3
Carc. 2
804-373-8
951659-40-8
Acute Tox. 4; STOT RE 2
204-255-0
118-48-9
Eye Irrit. 2; Skin Sens. 1
R-GELB 2454
400-680-2
98181-47-6
Acute Tox. 4
204-525-8
122-15-6
Acute Tox. 3
HYDRAMETHYLNON
405-090-9
67485-29-4
STOT RE 1; Acute Tox. 4; Eye Irrit. 2
PIGMENTROT 1017; SUBSTANCE H112287
405-100-1
115662-06-1
Repr. 2
251-684-4
33813-20-6
Acute Tox. 4
421-170-6
138937-28-7
Acute Tox. 4; Eye Dam. 1
IMEXINE OAY
412-130-9
3131-52-0
Acute Tox. 4; Eye Dam. 1
123U83; DDFU
415-360-8
41107-56-6
Muta. 2
410-530-8
107815-88-3
Skin Sens. 1
WAY-128170
420-820-6
153042-18-3
Flam. Liq. 3; Acute Tox. 4
-
51-14-9
Acute Tox. 4
414-410-6
1379676-83-1
Eye Dam. 1; Skin Sens. 1
ROUGE REACTIF REN 208
418-380-5
168113-78-8
Eye Dam. 1
433-530-1
143446-73-5
Acute Tox. 4; Skin Sens. 1
5-ACETYL-3-AMINO-IMINODIBENZYL.HCL
410-490-1
138451-65-7
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
ATIPACL
417-220-1
37441-29-5
Skin Sens. 1
428-410-9
67014-36-2
Acute Tox. 4; Skin Sens. 1
FAT 92'374
413-480-5
24856-00-6
Acute Tox. 4; Skin Sens. 1
CP-13,853
412-200-9
17630-75-0
Repr. 2; Acute Tox. 4; Skin Sens. 1
CDFP
410-090-7
89402-43-7
Flam. Liq. 3; Acute Tox. 4
429-290-0
3380-30-1
Eye Dam. 1
435-000-3
22094-83-3
Asp. Tox. 1; Skin Irrit. 2
428-330-4
2833-30-9
Skin Corr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
414-470-3
95885-13-5
Acute Tox. 4
619-823-7
494793-67-8
Carc. 2
208-793-7
541-85-5
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
203-737-8
110-12-3
Flam. Liq. 3; Acute Tox. 4
5-METHYLPYRAZINE-2-CARBOXYLIC ACID; ACIDO 5-METILPIRAZIN CARBOSSILICO
413-260-9
5521-55-1
Eye Dam. 1
202-765-8
99-55-8
Carc. 2; Acute Tox. 3
256-960-8
51085-52-0
Carc. 2; Acute Tox. 3
210-025-0
602-87-9
Carc. 1B
-
-
yes
-
-
yes
-
-
yes
BISOX HCL
404-840-2
164578-13-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
A-87440.0; A-87440.00
414-780-9
38585-74-9
Eye Dam. 1
ROUGE TZ 4075
418-340-7
157707-94-3
Eye Dam. 1
BLEU REN 20
418-000-8
163062-28-0
Eye Dam. 1
441-550-5
-
Self-react. C; Carc. 2
301-467-6
94021-76-8
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
239-732-2
15662-33-6
Acute Tox. 4
RONACAT RO 305; RONACOAT RO 305
404-870-6
63740-41-0
Skin Sens. 1
ELFADOX EN 3001
406-680-9
104788-63-8
Org. Perox. C; Eye Dam. 1; Skin Sens. 1
PAP
410-850-8
128275-31-0
Org. Perox. D; Eye Dam. 1
AF-507; M-3181
404-680-3
1862-07-3
Acute Tox. 4; Skin Corr. 1B
ENS 131
404-550-6
130263-41-1
Skin Sens. 1
UK-103,442
422-460-5
137234-87-8
Acute Tox. 4
IN-4; INDENE IN-4
405-410-7
41201-60-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
429-960-2
27610-48-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
ARANCIO DISPERSO 149; C.I. DISPERSE ORANGE 149; DISPERS ORANGE 149; DISPERSE ORANGE 149; ORANGE DISPERSE 149; TERASIL GOLDGELB 2RS
400-340-3
85136-74-9
Carc. 1B
IMEXINE OBA
417-020-4
2380-86-1
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
204-419-1
120-71-8
Carc. 1B; Acute Tox. 4
yes
DM-C-TDA; DMTDA; ETHACURE (R) 300 CURATIVE
403-240-8
106264-79-3
Acute Tox. 4; Skin Sens. 1
202-095-6
91-76-9
Acute Tox. 4
FLEXSORB-SE
400-390-6
87787-67-5
Skin Corr. 1A; Acute Tox. 4
ORANGE BIREACTIVE DYE
407-050-6
117715-57-8
Skin Sens. 1
TACS
403-690-5
111298-82-9
Resp. Sens. 1; Skin Sens. 1
424-850-0
189702-72-5
Eye Dam. 1
FLUORCHINOLONCARBONSÄURE
405-050-0
86393-33-1
Acute Tox. 4
429-400-7
199327-61-2
Repr. 1B
7-METHYL-1,6-OCTADIENE
404-210-7
42152-47-6
Flam. Liq. 3
ZOLDINE RD-20
417-140-7
79185-77-6
Skin Irrit. 2
OPALAL
424-030-2
62406-73-9
Skin Irrit. 2
-
10027-06-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
204-957-7
129-64-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
8-AMINO-7-METHYLCHINOLIN
412-760-4
5470-82-6
Acute Tox. 4; Skin Sens. 1
3,3-TETRAMETHYLENE GLUTARIMIDE
427-770-4
1075-89-4
Acute Tox. 3
201-281-4
80-47-7
Org. Perox. D; Skin Corr. 1B; Acute Tox. 4
BPFL; FLUOREN-BIS-PHENOL
406-950-6
3236-71-3
Eye Irrit. 2; Skin Irrit. 2
FLEUROXENE
430-830-2
26912-64-1
Skin Irrit. 2
216-055-0
1484-13-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
421-940-1
28698-31-9
Eye Dam. 1
416-360-0
162221-28-5
Skin Sens. 1
M1
422-060-0
137390-08-0
Acute Tox. 2
218-575-3
2186-25-6
Muta. 2; Skin Irrit. 2; Skin Sens. 1
218-574-8
2186-24-5
Muta. 2; Skin Irrit. 2; Skin Sens. 1
247-711-4
26447-14-3
Muta. 2; Skin Irrit. 2; Skin Sens. 1
426-890-4
77341-67-4
Eye Dam. 1
NITROGELB
410-700-1
27080-42-8
Skin Sens. 1
433-690-0
167678-46-8
Skin Corr. 1A; Skin Sens. 1
219-943-6
2580-56-5
yes
419-270-1
123599-82-6
Eye Irrit. 2
235-715-9
12607-70-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
419-840-8
169104-71-6
Flam. Sol. 1; Skin Corr. 1B; Skin Sens. 1
425-520-9
197179-61-6
Eye Dam. 1
273-688-5
69011-06-9
yes
SQ 28,796
415-820-8
137590-32-0
Eye Dam. 1; Skin Sens. 1
265-748-4
65405-96-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
CCA-VERSUCHSPRODUKT SN 4001
405-080-4
118725-24-9
Eye Dam. 1
615-339-5
71751-41-2
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
-
-
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.
A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260°C to 290°C (500°F to 554°F).
309-851-5
101316-45-4
Carc. 1B
-
-
P Parasites
250-241-2
30560-19-1
Acute Tox. 4
611-595-7
57960-19-7
Skin Sens. 1; STOT SE 1; STOT RE 2
200-836-8
75-07-0
Flam. Liq. 1; Carc. 1B; Muta. 2; Eye Irrit. 2; STOT SE 3
200-473-5
60-35-5
Carc. 2
603-921-1
135410-20-7
Acute Tox. 4
200-580-7
64-19-7
Flam. Liq. 3; Skin Corr. 1A
257-175-3
51404-69-4
yes
203-564-8
108-24-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
251-899-3
34256-82-1
Carc. 2; Repr. 2; Acute Tox. 4; STOT SE 3; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
200-662-2
67-64-1
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
200-835-2
75-05-8
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2
202-708-7
98-86-2
Acute Tox. 4; Eye Irrit. 2
200-865-6
75-36-5
Flam. Liq. 2; Skin Corr. 1B
200-816-9
74-86-2
Flam. Gas 1; Press. Gas
CGA 245704 TECH.
420-050-0
135158-54-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
256-634-5
50594-66-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
277-704-1
74070-46-5
Carc. 2; Skin Sens. 1A
206-121-7
302-27-2
Acute Tox. 2
203-453-4
107-02-8
Flam. Liq. 2; Acute Tox. 1; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
201-173-7
79-06-1
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
yes
419-560-6
4369-14-6
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
247-118-0
25584-83-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
201-177-9
79-10-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
203-466-5
107-13-1
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
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.
-
-
yes
-
-
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.
-
-
B Bacteria and similar species
204-673-3
124-04-9
Eye Irrit. 2
240-110-8
15972-60-8
Carc. 2; Acute Tox. 4; Skin Sens. 1
204-123-2
116-06-3
Acute Tox. 2; Acute Tox. 3
206-215-8
309-00-2
Carc. 2; Acute Tox. 3; STOT RE 1
240-896-2
16871-90-2
Acute Tox. 3
240-934-8
16893-85-9
Acute Tox. 3
240-968-3
16919-19-0
Acute Tox. 3
-
-
Acute Tox. 4
270-651-5
68475-57-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
292-456-4
90622-55-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
287-476-5
85535-84-8
Carc. 2
yes
292-454-3
90622-53-0
Carc. 1B
287-477-0
85535-85-9
Lact.
270-652-0
68475-58-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-653-6
68475-59-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-654-1
68475-60-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
435-660-2
243662-67-1
Skin Irrit. 2; Skin Sens. 1
435-650-8
-
Acute Tox. 4; Skin Corr. 1A
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
202-270-7
93-71-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
203-470-7
107-18-6
Flam. Liq. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-442-4
106-92-3
Flam. Liq. 3; Carc. 2; Muta. 2; Repr. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
202-473-0
96-05-9
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4
203-463-9
107-11-9
Flam. Liq. 2; Acute Tox. 3
603-801-9
134237-50-6
yes
-
-
Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
231-208-1
7446-70-0
Skin Corr. 1B
240-877-9
16853-85-3
Water-react. 1; Skin Corr. 1A
244-088-0
20859-73-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
231-072-3
7429-90-5
Water-react. 2; Flam. Sol. 1
231-072-3
7429-90-5
Water-react. 2; Pyr. Sol. 1
209-090-8
555-31-7
Flam. Sol. 1
604-314-4
142844-00-6
yes
212-634-7
834-12-8
Acute Tox. 4
-
919-76-6
Acute Tox. 4
262-977-1
61788-46-3
Acute Tox. 4; Asp. Tox. 1; STOT SE 3; STOT RE 2; Skin Corr. 1B
262-976-6
61788-45-2
Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
268-626-9
68131-73-7
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
268-626-9
68131-73-7
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
263-125-1
61790-33-8
Acute Tox. 4; Asp. Tox. 1; STOT RE 2; Skin Corr. 1B
217-990-7
2032-59-9
Acute Tox. 3
672-776-4
348635-87-0
Carc. 2; Eye Irrit. 2
251-375-4
33089-61-1
Acute Tox. 4; STOT RE 2; Skin Sens. 1
200-521-5
61-82-5
Repr. 2; STOT RE 2
215-647-6
1336-21-6
Skin Corr. 1B
231-635-3
7664-41-7
Flam. Gas 2; Press. Gas; Acute Tox. 3; Skin Corr. 1B
640 AMMONIUM SALT; KSMIA; S-102; SMIA
405-990-1
97148-39-5
Flam. Sol. 1

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