EU-MEDICAL_DEVICES-ANX_I_7_8

Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Directive 93/42/EEC, 12 July 1993, amended by Directive 2007/47/EC, 21 September 2007

This list contains hazardous substances in accordance with the Medical Devices Directive's (MDD) design and construction requirements pursuant to Annex I, Part II (7) & (8) (i.e., chemical, physical and biological properties; and infection and microbial contamination). Specifically, the 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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021.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 23 september 2021. Database contains 4812 unique substances/entries.
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203-770-8
110-46-3
Flam. Liq. 2; Acute Tox. 4
412-170-7
83623-61-4
STOT RE 2; Eye Dam. 1; Skin Sens. 1
430-460-1
133636-82-5
Skin Corr. 1B; Skin Sens. 1
-
-
Skin Sens. 1
432-360-3
105813-13-6
Acute Tox. 4; Skin Sens. 1
406-030-4
105812-81-5
Acute Tox. 4; Eye Dam. 1
214-619-0
1166-46-7
Carc. 2; Acute Tox. 4; STOT SE 2
425-230-2
16610-63-2
Skin Corr. 1B
256-032-2
42978-66-5
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
-
-
Skin Irrit. 2
427-580-1
2135337-60-7
Skin Irrit. 2
418-530-1
79200-56-9
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
411-000-9
125224-62-6
Skin Sens. 1
-
135821-03-3
yes
-
135821-74-8
yes
412-670-5
54275-93-3
Resp. Sens. 1
412-800-0
76109-32-5
Resp. Sens. 1
426-200-1
172015-79-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
420-560-3
79617-97-3
Eye Dam. 1
220-384-5
2746-19-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
426-740-8
-
Acute Tox. 4; Eye Dam. 1
407-240-9
159604-94-1
Skin Sens. 1
443-840-7
4084-38-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
439-360-2
142877-45-0
Skin Irrit. 2; Eye Dam. 1
430-620-0
76145-91-0
STOT RE 2; Skin Sens. 1
433-520-5
82911-69-1
Acute Tox. 4; Skin Sens. 1
430-910-7
13335-71-2
Acute Tox. 4; Eye Dam. 1
404-940-6
86608-70-0
Acute Tox. 4; Eye Dam. 1; STOT RE 2
417-410-4
61807-67-8
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
444-800-1
141645-23-0
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
429-740-6
40722-80-3
Carc. 1B; Muta. 1B; STOT RE 2; Skin Sens. 1
284-351-7
84852-39-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-470-2
85508-45-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
440-620-2
920-36-5
Water-react. 1; Pyr. Liq. 1; Skin Corr. 1A; STOT SE 3
420-370-0
6485-67-2
Eye Irrit. 2; Skin Sens. 1
-
75166-31-3
yes
-
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
433-820-6
118058-74-5
Eye Irrit. 2
408-050-9
76855-69-1
Eye Irrit. 2; Skin Sens. 1
425-260-6
244634-31-9
STOT RE 2; Eye Dam. 1; Skin Sens. 1
201-501-9
83-79-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
-
1417782-03-6
Skin Sens. 1
-
75166-30-2
yes
443-560-5
88784-33-2
Eye Irrit. 2
427-200-4
76646-91-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
422-240-9
166596-68-5
Eye Dam. 1; Skin Sens. 1
428-230-0
79568-06-2
STOT RE 2
222-048-3
3327-22-8
Carc. 2
423-290-4
66938-41-8
Muta. 2
420-380-5
136465-81-1
Acute Tox. 4; Eye Dam. 1

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