Information about REACH (Registration, Evaluation, Authorization 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 | |
| XP 115 VS | Siloxanes (D4, D5 & D6), DBMC |
| SDS-TRF-CV | Siloxanes (D4, D5 & D6) |
| LPDCT 50 | DEHP |
| SSQK 115 | Siloxanes (D4, D5 & D6), DBMC |
| SDS MP1 | Siloxanes (D4, D5 & D6) |
| SDS MP2 | Siloxanes (D4, D5 & D6) |
| SIT 96V | Siloxanes (D4, D5 & D6) |
| SQK 65VS | Siloxanes (D4, D5 & D6), DBMC |
| CVTS | DEHP, Siloxanes (D4, D5 & D6) |
| INT CPS | DEHP, Siloxanes (D4, D5 & D6), DOTE |
| INT CSS | DOTE |
| MRTS | DEHP, Siloxanes (D4, D5 & D6) |
| XP 65_115VS | Siloxanes (D4, D5 & D6), DBMC |
| SSQK 65/115VS | Siloxanes (D4, D5 & D6), DBMC |
| 150-FT | DBMC |
| 150-FT-Q | DBMC |
| 200-FT | DBMC |
| 200-FT-Q | DBMC |
| ART 700 SYR | DBMC |
| TAG 150 SYR | DBMC |
| AVA 500 MPAT | DBMC |
| AVA 500 SYR | DBMC |
| FLEXD-150-SPK | Siloxanes (D4, D5 & D6) |
| FLEXD-150-SCS | Siloxanes (D4, D5 & D6) |
| FLEXS-150-SPK | Siloxanes (D4, D5 & D6) |
| FLEXS-200-SPK | Siloxanes (D4, D5 & D6) |
| FLEXS-200-SCS | Siloxanes (D4, D5 & D6) |
| FLEXS-200-SPK | Siloxanes (D4, D5 & D6) |
| XP MP | Siloxanes (D4, D5 & D6), DBMC |
| SPD 250 | Siloxanes (D4, D5, D6) |
| SDS-CTP-SCS | Siloxanes (D4, D5 & D6) |
| SSS-CTP-SPK | Siloxanes (D4, D5 & D6) |
| SSS-SPK | Siloxanes (D4, D5 & D6) |
| SQK 65VA | Siloxanes (D4, D5 & D6), DBMC |
| SVTS | Siloxanes (D4, D5 & D6) |
| Stellant FLEX Injector | |
| FLEX | Lead, BPA, Lead Monoxide, DBMC, Melamine, D6 |
| FLEX UPG | Lead, BPA, Lead Monoxide, DBMC, Melamine, D6 |
| FLEX WCRU | Lead, EGDME |
| W3CT | Lead, EGDME, Lead Monoxide, Diboron Trioxide |
| ISI Systems | |
| ISI 900G | Lead, Lead Monoxide, Lead Titanium Trioxide, Diboron Trioxide, BPA |
| ISI 900S | Lead, Lead Monoxide, Lead Titanium Trioxide, Diboron Trioxide, BPA |
| ISI 900S VA-40 | Lead, Lead Monoxide, Lead Titanium Trioxide, Diboron Trioxide, BPA |
| ISI 900H | Lead, Lead Monoxide, Lead Titanium Trioxide, Diboron Trioxide, BPA |
| ISI 900T | Lead, Lead Monoxide, Lead Titanium Trioxide, Diboron Trioxide, BPA |
| ISI 800 | Lead, Lead Monoxide, Lead Titanium Trioxide, Diboron Trioxide, BPA |
| ISI 700 | Lead, Lead Monoxide, Lead Titanium Trioxide, Diboron Trioxide, BPA |
| ISI2 | Lead, TBBPA |
| Stellant and Stellant with Certegra Injector Systems | |
| Certegra base system | Lead, D6, Melamine, DBMC |
| Dual Base System, Classic | Lead, Diboron Trioxide, NMP |
| SDU 700 | Lead, Diboron Trioxide, NMP |
| SEC 700 | Lead |
| SHU 702 | Lead |
| SHU 711 | Lead |
| CWKS DISPLAY | Lead, EGDME |
| ASSY, PCB, ETHERNET SWITCH | Lead, Diboron Trioxide |
| SSEP Injector System and iCBC | |
| SSMR EP M | Lead, Diboron Trioxide, D4, Dechlorane +, DBMC, 2, 3-DBPA |
| iCBC base system | Lead |
| Arterion Injector System | |
| ART 700 PEDL | Lead, Diboron Trioxide, DBMC, D6, Melamine, Lead Monoxide |
| ART 700 TABL | Lead, Diboron Trioxide, DBMC, D6, Melamine, Lead Monoxide |
| XMC 927A | Lead |
| XMC 925A | Lead |
| MRXPerion Injector System | |
| MRXP 200 | Lead, D4, DBMC, 4-tert-butylphenol |
| MRXP PEN PNL | Lead |
| MRXP WCRU | Lead, EGDME |
| W3MT(WS3T) | Lead, EGDME, Lead Monoxide, Diboron Trioxide, Formaldehyde |
| Avanta Injector System | |
| AVA 500 TABL | Lead, Lead Monoxide, Siloxanes (D4, D5 & D6), Dechlorane +, BPA, 2-benzyl-2-dimethylamino-4'morpholinobutyrophenone, ADCA, N,N-dimethylformamide, Dibutylbis(pentane-2,4-dionato-O,O') tin, Diboron Trioxide, Cadmium Oxide, DBMC |
| AVA 500 PEDL | Lead, Lead Monoxide, Siloxanes (D4, D5 & D6), Dechlorane +, BPA, 2-benzyl-2-dimethylamino-4'morpholinobutyrophenone, ADCA, N,N-dimethylformamide, Dibutylbis(pentane-2,4-dionato-O,O') tin, Diboron Trioxide, Cadmium Oxide, DBMC |
| AVA 500 ISI | Lead |
| AVA HC | DBMC |
| VF HC | DBMC |
| Intego Injector System | |
| INT SYS 200 | Lead, BPA, Cadmium, Cadmium Oxide, EGDME, Lead titanium trioxide |
| POC-615 | Lead, EGDME |
| CLAMP, CABLE, CONNECTOR LOCK | Lead |
| Virtual Care | |
| Ethernet Switch Kit, Service | Lead, Lead Monoxide, D6, Melamine, Diboron Trioxide |
| AEC-6420 Power Supply | Lead |
| MEDPC-2000 Power Supply | Lead |
| Service Key | Lead, Lead Monoxide, EGDME |
| Centargo Injector System | |
| CENT-SYS-BAT | Lead, Lead Monoxide, D6, EGDME, TBBPA 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one |
| CENT-SYS-OCS | Lead, Lead Monoxide, D6, EGDME, TBBPA, 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one |
| CENT-BCC | Lead, EGDME, Lead Monoxide, Diboron Trioxide, Lead Titanium Trioxide, EGDME, TBBPA |
| W3CZ | Lead, EGDME, Lead Monoxide, Diboron Trioxide |
| Salient and Vistron Plus Injector Systems | |
| Base systems | Lead, EGDME, D4, D5, D6, Diboron trioxide, Lead monoxide, Lead titanium trioxide, BPA, 2-methyl-1-(4- methylthiophenol)-2-morpholinopropan-1-one |
| Power Cords | |
| CPC 700 | Lead |
| JAP-PWR-CRD | Lead |
| Service Kits | |
| KSP 935 | 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, INT CPS, CVTS, MRTS
The most current candidate list of substances can be found here.
For further information regarding Bayer products, please contact your Bayer Radiology Sales or Services Representative.
More information on REACH and Substances of Very High Concern can be found on the website of the European Chemicals Agency (ECHA).
