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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 24 May 2024. Database contains 4753 unique substances/entries.
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218-961-1
2303-16-4
Carc. 2; Acute Tox. 4
245-152-0
22673-19-4
Repr. 1B; STOT RE 1
yes
220-487-5
2782-57-2
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
246-356-2
24613-89-6
Ox. Sol. 1; Carc. 1B; Skin Corr. 1A; Skin Sens. 1
yes
248-523-5
27554-26-3
Repr. 1B
432-860-1
255387-46-3
Skin Sens. 1
246-673-6
25154-54-5
Acute Tox. 2; Acute Tox. 1; STOT RE 2
247-096-2
25550-58-7
Acute Tox. 3; STOT RE 2
246-836-1
25321-14-6
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
220-639-0
2844-92-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
432-980-4
243858-60-8
Eye Dam. 1
423-730-5
250688-43-8
Eye Dam. 1
206-054-3
298-04-4
Acute Tox. 1; Acute Tox. 2
219-196-6
2385-85-5
Carc. 2; Repr. 2; Lact.; Acute Tox. 4
431-760-5
27460-02-2
Skin Irrit. 2
219-459-5
2439-10-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
220-472-3
2778-04-3
Acute Tox. 3
206-080-5
299-42-3
Acute Tox. 4
249-981-9
29973-13-5
Acute Tox. 4
245-949-3
23947-60-6
Acute Tox. 4
429-020-1
204254-96-6
STOT RE 2; Skin Sens. 1
244-845-5
22212-55-1
Acute Tox. 4
ET 344 SP
412-540-8
22471-55-2
Skin Irrit. 2
219-732-9
2514-53-6
Skin Irrit. 2
219-991-8
2593-15-9
Carc. 2; Acute Tox. 4; Skin Sens. 1
447-880-6
206565-89-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
244-848-1
22224-92-6
Acute Tox. 2; Eye Irrit. 2
206-082-6
299-84-3
Acute Tox. 4
205-912-4
206-44-0
yes
243-547-2
20153-50-8
Acute Tox. 4
243-546-7
20153-49-5
Acute Tox. 4
500-036-1
25214-70-4
yes
244-879-0
22259-30-9
Acute Tox. 2; Skin Sens. 1
245-656-0
23422-53-9
Acute Tox. 2; Skin Sens. 1
219-818-6
2540-82-1
Acute Tox. 4
244-437-7
21548-32-3
Acute Tox. 1; Acute Tox. 2
206-058-5
298-12-4
Eye Dam. 1; Skin Sens. 1B
219-468-4
2439-99-8
Eye Dam. 1
GUANIDINIUMBENZOAT
429-820-0
26739-54-8
Acute Tox. 4
TILCOM HTB
411-740-2
22411-22-9
Eye Dam. 1; Skin Sens. 1
218-165-4
2058-94-8
yes
245-737-0
23560-59-0
Acute Tox. 3
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gamma-hexabromocyclododecane EC / List no: 603-804-5 | CAS no: 134237-52-8
Hexabromocyclododecane EC / List no: 247-148-4 | CAS no: 25637-99-4
1,2,5,6,9,10-hexabromocyclodecane EC / List no: 221-695-9 | CAS no: 3194-55-6
beta-hexabromocyclododecane EC / List no: 603-802-4 | CAS no: 134237-51-7
alpha-hexabromocyclododecane EC / List no: 603-801-9 | CAS no: 134237-50-6
247-148-4
25637-99-4
Repr. 2; Lact.
yes
247-094-1
25550-51-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
247-143-7
25637-27-8
Acute Tox. 4
219-698-5
2499-95-8
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
244-077-0
20845-01-6
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
DP-3337
405-710-8
23783-26-8
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
206-019-2
288-32-4
Repr. 1B; Acute Tox. 4; Skin Corr. 1C
244-959-5
22398-80-7
Carc. 1B; Repr. 2; STOT RE 1

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