EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It 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). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 27 svibnja 2024. Database contains 4821 unique substances/entries.
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604-398-2
144171-61-9
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
LATEMUL S-180 A
410-540-2
116726-92-2
Skin Irrit. 2; Skin Sens. 1
SCARLET DER 8107
429-070-4
214362-06-8
Eye Dam. 1
307-769-4
97722-19-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
The complex combination of hydrocarbons obtained as a raffinate from a Lurgi separation unit. It consists predominantly of non-aromatic hydrocarbons with various small amounts of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8.
270-349-3
68425-35-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained as the raffinate from the UDEX extraction process on the catalytic reformer stream. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C9.
270-088-5
68410-71-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
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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.
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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.
(R)-EPICHLOROHYDRIN
424-280-2
51594-55-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
SCH.19927 DIBENZOYLTARTRATE
404-390-7
88976-55-0
Flam. Sol. 1; Skin Sens. 1
PANTERA; QUIZALOFOP-P-TEFURYL
414-200-4
119738-06-6
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2
201-435-0
82-68-8
Skin Sens. 1
602-997-3
124495-18-7
Skin Sens. 1
219-455-3
2439-01-2
Repr. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
202-051-6
91-22-5
Carc. 1B; Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
205-711-1
148-24-3
Repr. 1B; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
BAS 514 H
402-780-1
84087-01-4
Skin Sens. 1
237-031-6
13593-03-8
Acute Tox. 3; Acute Tox. 4
264-151-6
63449-41-2
Acute Tox. 4; Skin Corr. 1B
610-007-6
422556-08-9
Skin Sens. 1
611-516-6
57369-32-1
Acute Tox. 4
201-762-9
87-66-1
Muta. 2; Acute Tox. 4
236-671-3
13463-41-7
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1
The complex combination of polyalkylated pyridines derived from coal tar distillation or as high-boiling distillates approximately above 150°C (302°F) from the reaction of ammonia with acetaldehyde, formaldehyde or paraformaldehyde.
269-929-9
68391-11-7
Carc. 1B; Muta. 1B
203-809-9
110-86-1
Flam. Liq. 2; Acute Tox. 4
259-686-7
55512-33-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
PYRIDABEN
405-700-3
96489-71-3
Acute Tox. 3
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Acute Tox. 4
-
108-34-9
Acute Tox. 2; Acute Tox. 1
236-656-1
13457-18-6
Acute Tox. 4
429-520-1
4023-02-3
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
605-747-1
175013-18-0
Acute Tox. 3; Skin Irrit. 2
602-927-1
123312-89-0
Carc. 2; Repr. 2
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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.
-
68583-29-9
B Bacteria and similar species
205-443-5
140-93-2
Acute Tox. 4; Skin Irrit. 2
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B Bacteria and similar species
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-
B Bacteria and similar species
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-
B Bacteria and similar species
218-893-2
2275-18-5
Acute Tox. 1; Acute Tox. 2
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
232-966-6
9068-59-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
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Proteinase, pancreatic EC / List no: 232-626-7 | CAS no: 9001-72-3
Proteinase, Myxobacter α-lytic EC / List no: 253-448-6 | CAS no: 37288-76-9
Proteinase, Bacillus subtilis, sutilain EC / List no: 235-390-3 | CAS no: 12211-28-8
Proteinase, Bacillus subtilis metallo- EC / List no: 232-991-2 | CAS no: 9080-56-2
Proteinase, Aspergillus alkaline EC / List no: 232-977-6 | CAS no: 9074-07-1
Proteinase, Tritirachium album serine EC / List no: 254-457-8 | CAS no: 39450-01-6
Proteinase, Aspergillus melleus, semialkaline EC / List no: - | CAS no: 76106-83-7
Proteinase, Serratia extracellular EC / List no: 253-457-5 | CAS no: 37312-62-2
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Proteinase, Aspergillus neutral EC / List no: 278-588-5 | CAS no: 77000-13-6
Proteinase, Bacillus alkaline EC / List no: 232-972-9 | CAS no: 9073-77-2
Proteinase, Bacillus subtilis serine EC / List no: 266-557-9 | CAS no: 67051-83-6
Proteinase, serine EC / List no: 253-431-3 | CAS no: 37259-58-8
Proteinase, Aspergillus oryzae neutral EC / List no: 232-990-7 | CAS no: 9080-55-1
Proteinase, Bacillus polymyxa neutral EC / List no: 255-914-4 | CAS no: 42613-33-2
Proteinase, bacterial E 30 serine EC / List no: - | CAS no: 39369-34-1
Proteinase, Staphylococcus aureus serine EC / List no: 259-611-8 | CAS no: 55354-32-0
Proteinase, microbial neutral EC / List no: 232-966-6 | CAS no: 9068-59-1
Proteinase, microbial alkaline EC / List no: 256-863-0 | CAS no: 50936-53-3
Proteinase, Bacillus licheniformis serine EC / List no: 279-361-3 | CAS no: 79986-26-8
Proteinase, Myxobacter AL-1, II EC / List no: 276-716-4 | CAS no: 72561-05-8
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Proteinase, microbial acid EC / List no: 256-862-5 | CAS no: 50936-52-2
Proteinase, Aspergillus niger neutral EC / List no: 254-422-7 | CAS no: 39346-39-9
Bacillus megaterium protease fermentation product EC / List no: - | CAS no: 68909-17-1
Proteinase, Bothrops atrox serine EC / List no: 232-918-4 | CAS no: 9039-61-6
Proteinase, serine (Tritirachium album) EC / List no: 686-165-5 | CAS no: 102925-54-2
Proteinase, Bacillus neutral EC / List no: 278-547-1 | CAS no: 76774-43-1
Myxobacteralphalyticproteinase EC / List no: - | CAS no: 12585-31-8
Proteinase, Bacillus alcalophilus serine EC / List no: 306-090-0 | CAS no: 95979-76-3
Proteinase, Bacillus subtilis EC / List no: 257-520-8 | CAS no: 51931-23-8
Proteinase, rhizopus acid EC / List no: 812-486-9 | CAS no: 9074-09-3
Proteinase, Endothia aspartic EC / List no: 253-395-9 | CAS no: 37205-60-0
Proteinase, Streptomyces griseus EC / List no: 232-909-5 | CAS no: 9036-06-0
Proteinase, Mucor aspartic EC / List no: 232-975-5 | CAS no: 9073-79-4
Proteinase, oryzin EC / List no: 232-992-8 | CAS no: 9081-30-5
Aspergillin M EC / List no: - | CAS no: 42615-60-1
Proteinase, aspartic EC / List no: 278-856-1 | CAS no: 78169-47-8
Proteinase, submandibular gland serine, A EC / List no: 279-893-6 | CAS no: 82047-85-6
Proteinase, Agkistrodon serine EC / List no: 232-933-6 | CAS no: 9046-56-4
Thrombin EC / List no: 232-648-7 | CAS no: 9002-04-4
Proteinase, Aspergillus parasiticus neutral EC / List no: 254-418-5 | CAS no: 39335-09-6
Proteinase, Aspergillus acid EC / List no: 232-796-2 | CAS no: 9025-49-4
934-013-6
39450-01-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
619-000-2
94125-34-5
Acute Tox. 4
PROSULFOCARB
401-730-6
52888-80-9
Acute Tox. 4; Skin Sens. 1
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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.
606-168-7
189278-12-4
Carc. 2
245-951-4
23950-58-5
Carc. 2

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