4th April 2017
Medasil Surgical Ltd
Silicone Surgical Solutions
Medasil House, Hunslet Road, Leeds, LS10 1AU. England
Tel: +44 (0)113 243 3491, Fax: +44 (0) 113 242 9276
E-mail: email@example.com Web: www.medasil.com
Revision 2 dated 04/04/2017
All Medasil products that are purchased “non-sterile”, which are intended for patient contact in theatre, or which are going to be in contact with blood or other bodily fluids, must be sterilized before use. Once sterilized they are to be considered “SINGLE USE ONLY”.
Recommended methods of sterilization by the end user are either Standard Gravity or Vacuum Autoclave at 134°C – 137°C with a holding time of 3 minutes.
The sterilizer should conform to BS EN 285 (Sterilization – Steam sterilizers. Large sterilizers) and any packaging should conform to EN 868 (a series of product specific standards to cover packaging materials and systems for medical devices which are to be sterilised). The sterilization should be carried out in compliance with BS EN ISO 17665-1 (Sterilization of Health Care Products. Moist Heat. Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices).
If your intended use does not involve patient or bodily fluid contact, then you should decide with your sterile services department if it is appropriate for the product to be used
non-sterile. The sterile services department must validate their processes and procedures to ensure their method is effective for the intended use.
It is recommended NOT to sterilize any Medasil tubing exceeding 1.82m (6ft) in length by any other method than gamma radiation.
For further information or advice regarding sterilization of Medasil products, please contact us at firstname.lastname@example.org