Bayer Radiology

REACH Information

Information about REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)

On December 18, 2006, the Council of the European Union adopted the REACH Regulation (EC) No 1907/2006. It entered into force on June 1, 2007. This regulation relates to chemical substances and their production and use in Europe. It is intended to better protect human health and the environment.

Bayer is aware of the obligations of this regulation and has implemented, amongst other REACH related tasks, an assessment and monitoring process for its Radiology medical devices. Bayer Radiology assesses items manufactured and imported into the European Union. With professional use, the articles produced are not intended to release substances. Based on the current information, these substances do not pose any risk, even in the context of disposal, if the articles are used as intended. Most SVHCs (Substances of Very High Concern) are contained within the electronic components of our electro-mechanical products and do not normally come into contact with operators or patients.

The following Bayer products contain parts with a SVHC substance above 0.1%:

Catalog # SVHC List Material(s)
Sterile Disposables
JTS-DCV DEHP, Siloxanes (D4, D5 & D6)
XP 115 VS Siloxanes (D4, D5 & D6)
SDS-TRF-CV Siloxanes (D4, D5 & D6)
LPDCT 50 DEHP
SSQK 115 Siloxanes (D4, D5 & D6)
SDS MP1 Siloxanes (D4, D5 & D6)
SIT 96V Siloxanes (D4, D5 & D6)
SJS-LP-60-T-J DEHP
SQK 65VS Siloxanes (D4, D5 & D6)
CVTS DEHP, Siloxanes (D4, D5 & D6)
INT CPS DEHP, Siloxanes (D4, D5 & D6), DOTE
MRTS DEHP, Siloxanes (D4, D5 & D6)
XP 65_115VS Siloxanes (D4, D5 & D6)
PRES 50 DOTE
   
ISI Systems
ISI 900G Lead, Lead Monoxide, Diboron Trioxide, BPA
ISI 900S Lead, Lead Monoxide, Diboron Trioxide, BPA
ISI 900S VA-40 Lead, Lead Monoxide, Diboron Trioxide, BPA
ISI 900H Lead, Lead Monoxide, Diboron Trioxide, BPA
ISI 900T Lead, Lead Monoxide, Diboron Trioxide, BPA
ISI 800 Lead, Lead Monoxide, Diboron Trioxide, BPA
ISI 700 Lead, Lead Monoxide, Lead Titanium Trioxide, Diboron Trioxide, BPA
Stellant and Stellant with Certegra Injector Systems
Certegra base system Lead
Dual Base System, 4th Lead, Diboron Trioxide, NMP
SPU 210 Lead, Diboron Trioxide, NMP
SDU 700 Lead, Diboron Trioxide, NMP
SEC 700 Lead
SHU 702 Lead
SHU 711 Lead
CWKS DISPLAY Lead, D4, EGDME
ASSY, PCB, ETHERNET SWITCH Lead, Diboron Trioxide
SSEP Injector System and iCBC
SSMR EP M Lead, Diboron Trioxide, D4, Dechlorane +
iCBC base system Lead
Arterion Injector System
ART 700 PEDL Lead, Diboron Trioxide, NMP
ART 700 TABL Lead, Diboron Trioxide, NMP
ART 700 2DCU Lead, Diboron Trioxide, NMP
XMC 927A Lead
XMC 925A Lead
XMC 928A Lead
MRXPerion Injector System
MRXP 200 Lead, D4
MRXP PEN PNL Lead
MRXP WCRU Lead, D4, EGDME
W3MT Lead, Lead Monoxide, Lead Titanium Trioxide, Titanium Dioxide
Avanta Injector System
AVA 500 TABL

Lead, Lead Monoxide, Siloxanes (D4, D5 & D6), Dechlorane +,
2-benzyl-2-dimethylamino-4'morpholinobutyrophenone,
ADCA, DMF, Dibutylbis(pentane-2,4-dionato-O,O') tin,
Diboron Trioxide, Cadmium Oxide
AVA 500 PEDL

Lead, Lead Monoxide, Siloxanes (D4, D5 & D6), Dechlorane +,
2-benzyl-2-dimethylamino-4'morpholinobutyrophenone,
ADCA, DMF, Dibutylbis(pentane-2,4-dionato-O,O') tin,
Diboron Trioxide, Cadmium Oxide
AVA 500 ISI Lead
Intego Injector System
INT SYS 200

Lead, BPA, Cadmium, Cadmium Oxide, EGDME, Orthoboric Acid,
Diazene-1,2-dicarboxamide (C,C'-azodi(formamide)), 4-tert-butylphenol,
1,3,5-Tris(oxiran-2-ylmethyl)-1,3,5-triazinane-2,4,6trione,
N,N-dimethylacetamide, 4,4'-oxydianiline and its salts,
2-methyl-1-(4-methylthiophenyl)-2morpholinopropan-1-one
CLAMP, CABLE, CONNECTOR LOCK Lead
Virtual Care
Ethernet Switch Kit, Service Lead, Diboron Trioxide
AEC-6420 Power Supply Lead
Service Key Lead, Lead Oxide
Centargo Injector System

CENT-SYS-BAT

Lead, Lead Monoxide, NMP,
2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one
W3CZ Lead, Lead Monoxide, Lead Titanium Trioxide
Salient and Vistron Plus Injector Systems
Base systems Lead, EGDME
Power Cords
CPC 700 Lead
JAP-PWR-CRD Lead

Some of the sterile disposable tubing sets sold by Bayer contain DEHP above 0.1% weight by weight. Information regarding safe use of these tubing sets can be found in the accompanying instructions for use provided with the product. The catalog numbers of these tubing sets are:

LPDCT 50, SJS-LP-60-T-J, INT CPS, CVTS, MRTS, JTS-DCV

hehp

The most current candidate list of substances can be found here.

For further information regarding Bayer products, please contact your Bayer Radiology UK.

More information on REACH and Substances of Very High Concern can be found on the website of the European Chemicals Agency (ECHA).