EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. 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).

Last updated 26 srpnja 2024. Database contains 4917 unique substances/entries.
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211-914-6
709-98-8
Acute Tox. 4
Details
200-827-9
74-98-6
Flam. Gas 1; Press. Gas
Details
204-623-0
123-38-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
200-661-7
67-63-0
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
Details
200-746-9
71-23-8
Flam. Liq. 2; Eye Dam. 1; STOT SE 3
Details
217-638-2
1918-16-7
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Details
203-471-2
107-19-7
Flam. Liq. 3; Acute Tox. 3; Skin Corr. 1B
Details
220-113-0
2631-37-0
Acute Tox. 3
Details
604-105-8
139001-49-3
Carc. 2; Repr. 2; Skin Sens. 1
Details
247-656-6
26399-36-0
Eye Irrit. 2
Details
255-255-2
41198-08-7
Acute Tox. 4
Details
425-740-5
-
Eye Dam. 1
Details
BROWN JR 547
419-260-5
-
Eye Dam. 1
Details
266-994-5
67747-09-5
Acute Tox. 4
Details
-
-
B Bacteria and similar species
Details
245-387-9
23031-36-9
Acute Tox. 3; Acute Tox. 4
Details
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-
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.
Details
ORANGE DER 8068
422-980-2
187026-95-5
Eye Dam. 1
Details
432-240-0
12056-51-8
Carc. 2
Details
425-830-4
-
Eye Dam. 1
Details
SUMIFIX BRILLIANTBLAU GL KONZENTRAT
414-100-0
154336-20-6
Eye Dam. 1
Details
C.I. REACTIVE RED 231
402-150-6
-
Eye Irrit. 2; Skin Sens. 1
Details
REAKTIVROT 2713
412-490-7
-
Skin Sens. 1
Details
C.I. REACTIVE YELLOW 138:1
403-810-6
140876-13-7
Eye Dam. 1
Details
-
5787-96-2
Acute Tox. 3; STOT RE 2
Details
253-390-1
37199-66-9
Skin Corr. 1B
Details
231-760-3
7722-64-7
Ox. Sol. 2; Repr. 2; Acute Tox. 4
Details
220-527-1
2795-39-3
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
Details
223-393-2
3871-99-6
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
701-468-5
21049-36-5
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
231-912-9
7778-74-7
Ox. Sol. 1; Acute Tox. 4
Details
231-911-3
7778-73-6
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
231-832-4
7758-09-0
Ox. Sol. 2; Acute Tox. 3
Details
POTASSIUM-P-TOLYLSULFIMIDE
406-650-5
97888-41-0
Eye Dam. 1
Details
POTASSIUM N-(4-FLUOROPHENYL)GLYCINATE
415-710-1
184637-63-6
STOT RE 2; Eye Dam. 1; Skin Sens. 1
Details
D(-) VALINE DANE SALT
427-240-2
134841-35-3
Skin Sens. 1
Details
EURELYT
400-040-2
12091-08-6
Flam. Sol. 1; Water-react. 1; Skin Corr. 1A; Acute Tox. 4
Details
212-736-1
865-33-8
Self-heat. 1; Skin Corr. 1B
Details
FEKPDTA; KFEPDTA
405-680-6
148434-01-9
Self-heat. 2
Details
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-
C Carcinogenic (article 57a)
Details
215-181-3
1310-58-3
Acute Tox. 4; Skin Corr. 1A
Details
231-594-1
7646-93-7
Skin Corr. 1B; STOT SE 3
Details
232-151-5
7789-23-3
Acute Tox. 3
Details
430-010-4
12160-44-0
Skin Corr. 1B; Skin Sens. 1
Details
213-029-0
917-58-8
Self-heat. 1; Skin Corr. 1B
Details
231-906-6
7778-50-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
Details
209-676-3
590-28-3
Acute Tox. 4
Details
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
C Carcinogenic (article 57a)
M Mutagen (article 57b)
Details
223-289-7
3811-04-9
Ox. Sol. 1; Acute Tox. 3
Details
231-829-8
7758-01-2
Ox. Sol. 1; Carc. 1B; Acute Tox. 3
Details

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