NF EN ISO 7551, S91-231 (05/2023)

This document specifies the requirements and test methods for sterilized absorbent tips used in endodontics. Absorbent cones are sold sterilized or unsterilized. The requirements apply to absorbent cones that have been sterilized once, using a method approved by the manufacturer. This document specifies numerical systems and a color coding system for the designation of absorbent cone sizes. Clause 7 specifies the necessary labeling and packaging, including instructions for use. Any claim emanating from the manufacturer, indicating that the contents of the case before opening are sterile, are solely those of the manufacturer (see Table 2). This document does not establish requirements or test methods relating to sterility. NOTE 1 It is possible to refer to the national requirements in force. Reference is made to the internationally accepted pharmacopoeia. NOTE 2 National requirements may apply. Standards relating to sterilization process validation methods are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.
(Automatic translation from French)