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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 28 March 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

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