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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021.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 16 April 2024. Database contains 4753 unique substances/entries.
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3-CHLORO-4,5-DIFLUOROBENZOTRIFLUORIDE
401-930-3
77227-99-7
Flam. Liq. 3; Acute Tox. 4
445-590-4
202197-26-0
Muta. 2; Acute Tox. 4; STOT RE 2
ACTF; P-007
401-670-0
79456-26-1
Acute Tox. 4
-
15271-41-7
Acute Tox. 2; Acute Tox. 3
210-467-4
616-20-6
Flam. Liq. 2; Acute Tox. 4
203-582-6
108-43-0
Acute Tox. 4
203-457-6
107-05-1
Flam. Liq. 2; Carc. 2; Muta. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
CHLOROFORMIATE DE CHLORO 3 PROPYLE
425-770-9
628-11-5
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
203-580-5
108-41-8
Acute Tox. 4
ISOPHORONENITRILE, IPN
411-490-4
7027-11-4
Acute Tox. 4; STOT RE 2; Skin Sens. 1
SANDUVOR 3056
411-920-0
106917-30-0
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1A
UK-48,340
425-820-1
88150-42-9
Acute Tox. 3; STOT RE 2; Eye Dam. 1
ZOLDINE MS-PLUS
421-150-7
143860-04-2
Repr. 1B; Skin Corr. 1B
yes
210-187-2
609-26-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
213-923-0
1067-08-9
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
210-621-0
619-99-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
210-529-0
617-78-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
428-700-5
1873-90-1
Acute Tox. 4
LUPEROX 610-E-35; LUPEROX 610-E-50; LUPEROX 610-EN-50; LUPEROX 610-M-50; LUPERSOL 610; LUPERSOL 610-M-50
413-910-1
1467668-33-2
Org. Perox. C; Flam. Liq. 3; Skin Irrit. 2
220-426-2
2761-09-3
Eye Irrit. 2; Skin Sens. 1
259-627-5
55406-53-6
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1
209-130-4
556-56-9
Flam. Liq. 2; Skin Corr. 1B
223-861-6
4098-71-9
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
433-900-0
55066-49-4
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
SUBSTANCE S44176
414-570-7
18759-96-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
209-264-3
563-80-4
Flam. Liq. 2
209-660-6
589-81-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-643-3
589-34-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
202-481-4
96-14-0
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
-
2532-43-6
Acute Tox. 3
432-530-7
24294-01-7
Acute Tox. 4
CC14837; SKF 106224
414-990-0
302-97-6
Repr. 2
209-526-7
584-02-1
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
200-340-1
57-57-8
Carc. 1B; Acute Tox. 2; Eye Irrit. 2; Skin Irrit. 2
Z-29
418-990-1
778577-53-0
STOT RE 2; Eye Irrit. 2; Skin Irrit. 2
201-052-9
77-73-6
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
LICHTSCHUTZMITTEL 2577
407-600-5
120187-29-3
Muta. 2
DMA
407-500-1
21983-80-2
Skin Sens. 1
428-970-4
13595-25-0
Repr. 2; Skin Sens. 1
209-321-2
569-61-9
Carc. 1B
DIGLYCERINDIFORMAL (DGDF)
423-230-7
56552-15-9
Eye Dam. 1
204-358-0
119-93-7
Carc. 1B; Acute Tox. 4
209-218-2
561-41-1
yes
202-027-5
90-94-8
Carc. 1B; Muta. 2; Eye Dam. 1
yes
B-TUM
418-770-5
151882-81-4
Carc. 2
207-762-5
492-80-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2
ZP-DK 2115
407-590-2
43151-99-1
Acute Tox. 3; STOT RE 2; Skin Sens. 1
202-974-4
101-77-9
Carc. 1B; Muta. 2; STOT SE 1; STOT RE 2; Skin Sens. 1
yes
AROCY L-10
405-740-1
47073-92-7
Acute Tox. 4; STOT RE 2; Eye Dam. 1
420-530-1
177027-34-8
Resp. Sens. 1; Skin Sens. 1

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