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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 25 April 2024. Database contains 4753 unique substances/entries.
Filter the list

-
135821-03-3
yes
-
135821-74-8
yes
-
178961-20-1
Skin Sens. 1
-
4482-55-7
Skin Irrit. 2
-
6202-15-9
Expl. 1.1; Acute Tox. 4
-
540-73-8
Carc. 1B; Acute Tox. 3
-
-
yes
-
5836-73-7
Acute Tox. 2
-
7076-53-1
Acute Tox. 3
-
240494-71-7
Acute Tox. 4; Acute Tox. 3; STOT SE 1; STOT RE 2
-
1065124-65-3
Acute Tox. 4; STOT SE 2
-
130014-35-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
-
21436-97-5
Carc. 1B; Acute Tox. 3
-
72319-19-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
-
15271-41-7
Acute Tox. 2; Acute Tox. 3
-
2532-43-6
Acute Tox. 3
-
-
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
-
-
Carc. 1B; Acute Tox. 4
-
-
yes
-
-
yes
-
-
yes
-
-
yes
-
51-14-9
Acute Tox. 4
-
-
yes
-
-
yes
-
-
yes
-
10027-06-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
-
-
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.
-
-
P Parasites
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
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.
-
-
yes
-
-
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.
-
-
B Bacteria and similar species
-
-
Acute Tox. 4
-
-
Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
-
919-76-6
Acute Tox. 4
-
4149-60-4
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
show/hide
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Amylase, α-, Aspergillus oryzae EC / List no: 232-588-1 | CAS no: 9001-19-8
Amylase, alpha-, Bacillus amyloliquefaciens EC / List no: - | CAS no: 152923-48-3
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Amylase, gluco-, Rhizopus oryzae EC / List no: - | CAS no: 152923-55-2
Amylase, gluco- EC / List no: 232-877-2 | CAS no: 9032-08-0
Amylase, bacterial EC / List no: 232-560-9 | CAS no: 9000-85-5
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Amylase, fungal EC / List no: 232-742-8 | CAS no: 9013-01-8
Amylase, β- EC / List no: 232-566-1 | CAS no: 9000-91-3
Amylase, α- EC / List no: 232-565-6 | CAS no: 9000-90-2
Amylase, iso- EC / List no: 232-956-1 | CAS no: 9067-73-6
Amylase EC / List no: 232-567-7 | CAS no: 9000-92-4
-
-
Resp. Sens. 1
-
-
P Parasites
-
-
P Parasites
-
-
P Parasites
-
-
Acute Tox. 4
-
-
B Bacteria and similar species
-
-
Carc. 1A; Acute Tox. 3

Export search results to: