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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021.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 03 May 2024. Database contains 4753 unique substances/entries.
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640-104-9
210555-94-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
608-492-4
3050-88-2
yes
310-154-3
121158-58-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
276-743-1
72624-02-3
yes
291-844-0
90481-04-2
yes
203-632-7
108-95-2
Muta. 2; Acute Tox. 3; STOT RE 2; Skin Corr. 1B
201-004-7
77-09-8
Carc. 1B; Muta. 2; Repr. 2
yes
The combination of phenols extracted, using isobutyl acetate, from the ammonia liquor condensed from the gas evolved in low-temperature (less than 700°C (1292°F)) destructive distillation of coal. It consists predominantly of a mixture of monohydric and dihydric phenols.
284-881-9
84988-93-2
Carc. 1B; Muta. 1B
293-435-2
91079-47-9
Carc. 1B; Muta. 1B
219-997-0
2597-03-7
Acute Tox. 4
CGI 819
423-340-5
162881-26-7
Skin Sens. 1A
204-557-2
122-60-1
Carc. 1B; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
DPX-E6758
406-600-2
89392-03-0
Skin Sens. 1
202-873-5
100-63-0
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
248-259-0
27140-08-5
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
200-444-7
59-88-1
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
257-622-2
52033-74-6
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
200-532-5
62-38-4
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
202-866-7
100-57-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
200-242-9
55-68-5
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
206-052-2
298-02-2
Acute Tox. 1; Acute Tox. 2
223-874-7
4104-14-7
Acute Tox. 1; Acute Tox. 2
218-996-2
2310-17-0
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
213-423-2
947-02-4
Acute Tox. 1; Acute Tox. 2
200-870-3
75-44-5
Press. Gas; Acute Tox. 2; Skin Corr. 1B
211-987-4
732-11-6
Repr. 2; Acute Tox. 4; Acute Tox. 3; STOT SE 1
-
5826-76-6
Acute Tox. 4
236-116-5
13171-21-6
Muta. 2; Acute Tox. 2; Acute Tox. 3
232-260-8
7803-51-2
Flam. Gas 1; Press. Gas; Acute Tox. 1; Skin Corr. 1B
237-066-7
13598-36-2
Acute Tox. 4; Skin Corr. 1A
231-633-2
7664-38-2
Skin Corr. 1B
-
17169-61-8
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
233-663-1
10294-56-1
Acute Tox. 4; Skin Corr. 1A
233-060-3
10026-13-8
Acute Tox. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
215-236-1
1314-56-3
Skin Corr. 1A
232-178-2
7789-60-8
Skin Corr. 1B; STOT SE 3
231-749-3
7719-12-2
Acute Tox. 2; STOT RE 2; Skin Corr. 1A
233-046-7
10025-87-3
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Skin Corr. 1A
238-887-3
14816-18-3
Repr. 2; Acute Tox. 4; Skin Sens. 1
201-607-5
85-44-9
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
200-332-8
57-47-6
Acute Tox. 2
202-128-4
92-13-7
Acute Tox. 2
201-462-8
83-26-1
Acute Tox. 3; STOT RE 1
635-361-9
243973-20-8
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1A
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
205-551-2
142-64-3
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
228-042-7
6094-40-2
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
217-775-8
1951-97-9
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
203-813-0
110-89-4
Flam. Liq. 2; Acute Tox. 3; Skin Corr. 1B

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