Standards

Rocket Medical products have attained the CE mark and are designed to ISO9001

All of our products are manufactured to the stringent requirements of the US Food & Drug Administration (FDA) and the dedicated European medical standard ISO13485.

Bio compatibility

We are committed to ensuring that you receive products of the highest quality and to achieve this we only use materials with bio-compatibilities established for appropriate and intended use. 

Our materials are independently tested to appropriate FDA and European standards.

Sterilisation

Our products are sterilised using Gamma Irradiation or Ethylene Oxide (EtO), validated in accordance with FDA and European standards.

Certain products, for example those in the Rocket® IVF Range, are normally sterilised with Gamma Irradiation. This process ensures that there is no risk of residual contamination common with EtO

Rocket Medical plc has invested heavily in developing new materials to take advantage of these benefits

Mouse Embryo Testing (MEA)

To ensure you receive products of the highest quality certain items, such as those in Rocket® IVF Range, receive additional testing using the most rigorous Mouse Embryo Assay and LAL testing.

Documents

• Latex Statement:

• HSE: 'Latex & You' Ref: IDG320

• COSHH Statement:

• Non Disclosure Agreement

Certification

• CE 93 42 EEC:

• ISO 13485:

• ISO9001:

• ISO 13485 (Canada):

• ISO 13485 (Scope - Canada):