Product Materials, Bill of Materials
No. All Accu-Chek lancing devices, lancets, lancet drums, and SULDs are latex-free..
No. All Accu-Chek lancing devices, lancets, lancet drums, and SULDs are PVC-free and phthalate-free.
All lancets made out of the medical grade steel (type 1.4301, approved for medical purposes) contain nickel in small percentage. This is also the case for all Roche lancets: Accu-Chek FastClix, Accu-Chek Softclix, and Accu-Chek Multiclix, as well as for the Single-Use Lancing Devices for professional use. This stainless steel may contain small amounts of nickel, on average approximately 10%.
However, the same type of steel is also used in surgical knives, blades, cannulas, pen needles, etc. - all of which penetrate the skin deeper and stay within the skin longer than the Accu-Chek lancet needles, which
only stay in the skin for miniscule part of a second.
Nickel is also contained in a lot of items from coins to door handles, or cutlery or even food. A small amount of nickel is essential in the human body. Nickel allergy presents itself as a contact dermatitis which develops 12 to 48 hours after exposure to nickel ions. For a material, it is not relevant how much nickel they contain, but rather how many nickel ions can leak from the material. Therefore, medical grade steel can be used even as prostheses, as not enough nickel ions are released from the material to cause an allergic reaction.
From the Regulatory point of view: All used materials in the Accu-Chek lancets are approved to fulfill the international requirements for biocompatibility and cytotoxicity. They fulfil the requirements according to the European Council Directive 93142lEEC for Medical Devices, and are classified as Class IIa Medical Devices
All lancets made out of the medical grade steel (type 1.4301, approved for medical purposes) contain nickel in small percentage. This is also the case for all Roche lancets: Accu-Chek FastClix, Accu-Chek Softclix, and Accu-Chek Multiclix, as well as for the Single-Use Lancing Devices for professional use. This stainless steel may contain small amounts of nickel, on average approximately 10%.
However, the same type of steel is also used in surgical knives, blades, cannulas, pen needles, etc. - all of which penetrate the skin deeper and stay within the skin longer than the Accu-Chek lancet needles, which only stay in the skin for miniscule part of a second.
However, Kobalt is no ingredient of our lancets.
Please contact the Roche Diabetes Care Registration Desk:
[email protected]
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