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prEN ISO 7551 Public enquiry
Comment end date 2026-08-06
Dentistry - Endodontic absorbent points (ISO/DIS 7551:2026)

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.

prEN ISO 21606 Public enquiry
Comment end date 2026-07-23
Dentistry - Elastomeric auxiliaries for use in orthodontics (ISO/DIS 21606:2026)

This document specifies the requirements and their test methods applicable to all elastomeric auxiliaries used for orthodontics both inside and outside the mouth, in conjunction with fixed and removable appliances.

prEN ISO 20795-1 rev Public enquiry
Comment end date 2026-06-30
Dentistry - Base polymers - Part 1: Denture base polymers (ISO/DIS 20795-1:2026)

ISO 20795-1:2013 classifies denture base polymers and copolymers and specifies their requirements. It also specifies the test methods to be used in determining compliance with these requirements. It further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials. Furthermore, it applies to denture base polymers for which the manufacturer claims that the material has improved impact resistance. It also specifies the respective requirement and the test method to be used. ISO 20795-1:2013 applies to denture base polymers such as those listed below: poly(acrylic acid esters); poly(substituted acrylic acid esters); poly(vinyl esters); polystyrene; rubber modified poly(methacrylic acid esters); polycarbonates; polysulfones; poly(dimethacrylic acid esters); polyacetals (polyoxymethylene); copolymers or mixtures of the polymers listed in 1 to 9.

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