ISO 7551:2023 PDF

Scope: This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points. Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility. NOTE 1 Reference to applicable national regulations can be made. Reference is made to internationally accepted pharmacopoeia. NOTE 2 National requirements can apply. Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2

ISO 7551:2023 Referenced Document

ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
ISO 1942 Dentistry — Vocabulary — Amendment 1
ISO 20417 Medical devices — Information to be supplied by the manufacturer
ISO 3630-1 Dentistry — Endodontic instruments — Part 1: General requirements
ISO 6360-1 Dentistry — Number coding system for rotary instruments — Part 2: Shapes — Amendment 1*， 2024-04-22 Update
ISO 8601-1 Date and time — Representations for information interchange — Part 1: Basic rules — Amendment 1: Technical corrections