BS EN 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 and ISO 11137 - 3 .

BS EN 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*， 1985-07-01 Update
ISO 20417 Medical devices — Information to be supplied by the manufacturer*， 2021-04-13 Update
ISO 3630-1 Dentistry — Endodontic instruments — Part 1: General requirements*， 2019-08-23 Update
ISO 6360-1 Dentistry — Number coding system for rotary instruments — Part 2: Shapes — Amendment 1*， 2024-04-21 Update
ISO 8601-1 Date and time — Representations for information interchange — Part 1: Basic rules — Amendment 1: Technical corrections*， 2022-10-25 Update

1970 BS EN ISO 7551:2023 Dentistry. Endodontic absorbent points (British Standard)
1970 BS EN ISO 7551:1998
1997 BS EN ISO 7551:1997 Dental absorbent points