Please view our Guidance Document.
Please view our Guidance in the use of seal strength test EN 868-5 Annex D
The CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. Read more about CE marking at http://europa.euavautuu uuteen ikkunaan
Look at the legislation and standards review in the Healthcare section by clicking here.
Go to our Members page to find links to individual member sites, here.
Please refer to our position paper on CE Marking.
You can find information about the MDR here Regulation (EU) 2017/745avautuu uuteen ikkunaan and the IVDR here Regulation (EU) 2017/746avautuu uuteen ikkunaan.
The SBA has also prepared a guidance document on ‘Moving from MDD to MDR impact on packaging – Guidance document’ in the Library section of the website.
Infection prevention is the practice of preventing the spread of infectious diseases. It involves measures such as hand hygiene, cleaning and disinfection, and the use of sterile barriers to maintain a clean and safe environment for patients.
You can find information on symbols on the guidance document – EN ISO 15223-1 new symbols for SBS in the Library section of the website.
The Sterile Barrier Association (SBA) is the European trade association for manufacturers and suppliers of sterile barrier systems (SBS) materials, preformed SBS and related services, equipment and accessories, as well as companies who produce SBS for the healthcare industry. It was formed in 1992 to develop technical and safety standards for sterile barrier packaging and has consistently supported the introduction of patient safety, quality, and environmental standards.
A sterile barrier refers to the packaging material used to maintain the sterility of medical devices and equipment during storage and transportation. For more information on sterile barriers, please visit the section Sterile barrier systems in the website.
