Awards - CE Accreditation/IS EN ISO 13488
Steri Tex is a subsidiary company to Spring Grove and is the first supplier of reusable customised theatre packs to achieve the coveted CE accreditation in Ireland. This standard liciences the company to produce class IIA medical devices.
The Medical Devices Directives set out essential requirements to ensure that a medical device will not compromise the health and safety of the patient, user or any other person, and that any risks associated with the device are still compatible with patient health and protection.
All medical device manufacturers must CE mark the device they market to comply with EU medical device regulations. Steri Tex are the first and only company supplying reusable drapes and gowns in Ireland to comply with these regulations.