牙科材料标准-分析测试百科网

GSO ISO/TS 16506:2021 牙科含有粘合剂成分的聚合物基粘合材料

ISO/TS 16506:2017 specifies test methods and information of bond strength to dentine and physical and chemical performances of dental polymer-based luting materials containing adhesive components. The materials are supplied in a form suitable for mechanical mixing or hand-mixing, including using auto-mixing tips, for self-curing and/or external energy activation, or non-mixing for external energy activation. The polymer-based luting materials covered by this document are intended to be used for the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, posts, crowns and bridges. ISO/TS 16506:2017 does not cover the following polymer-based luting materials: a) those which do not have an adhesive component within the structure of the material (see ISO 4049); b) those intended for veneering sub-frames (see ISO 10477).

Dentistry — Polymer-based luting materials containing adhesive components

ICS: 11.060.10
CCS
发布: 2021-07-01
实施

GSO ISO 9693-2:2021 牙科兼容性测试第2部分：陶瓷陶瓷系统

ISO 9693-2:2016 specifies requirements and test methods to assess the compatibility of ceramic-ceramic materials used for dental restorations by testing composite structures. The requirements of this part of ISO 9693 apply when different ceramic components are used in combination. Compliance cannot be claimed for either ceramic alone. For requirements of ceramic materials, see ISO 6872.

Dentistry — Compatibility testing — Part 2: Ceramic-ceramic systems

ICS: 11.060.10
CCS
发布: 2021-07-01
实施

GSO ISO 13897:2021 牙科牙科汞合金可重复使用混合胶囊

ISO 13897:2018 specifies the requirements for reusable mixing-capsules intended to contain dental amalgam alloy powder and dental mercury when these are mixed to produce dental amalgam, and the test methods used to determine conformity to these requirements. NOTE ISO 7488 specifies requirements for mixing machines. The requirements for mixing-capsule are not dealt with in ISO 7488, although the mixing-capsule is an essential part of the mixing machine.

Dentistry — Dental amalgam reusable mixing-capsules

ICS: 11.060.10
CCS
发布: 2021-07-01
实施

GSO ISO 17254:2021 牙科用于正畸的卷簧

ISO 17254:2016 applies to coiled springs for use in orthodontic appliances. It gives details of methods to compare the physical and mechanical properties of coiled springs, the test methods by which they can be determined, as well as packaging and labelling requirements.

Dentistry — Coiled springs for use in orthodontics

ICS: 11.060.10
CCS
发布: 2021-07-01
实施

GSO EN 1641:2021 牙科牙科医疗设备材料

This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. For the purposes of this standard these materials are defined as restorative materials. Dental implants are specifically excluded and described in EN 1642. This standard also specifies general requirements for materials used in the practice of orthodontics. This standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer. Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.

Dentistry. Medical devices for dentistry. Materials

ICS: 11.060.10
CCS
发布: 2021-07-01
实施

GSO ISO 20749:2021 牙科预封装牙科汞合金

ISO 20749:2017 specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy and dental mercury in quantities suitable for the creation of a single dental restoration. ISO 20749:2017 specifies the requirements and test methods for dental amalgam alloys that are suitable for the preparation of dental amalgam and the capsule, together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking. ISO 20749:2017 is not applicable to dental amalgam alloys supplied as a free-flowing powder in bulk quantities or as powder compressed into tablets, or to dental mercury supplied in sachets or bulk quantities. This document is not applicable to other metallic materials in which an alloy powder reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration. Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological hazard are not included in this document. For the assessment of possible biological hazards, reference can be made to ISO 10993‑1 and ISO 7405. The scope of this document is restricted to dental amalgam products marketed in pre-capsulated form alone. Other products intended for use in the production of dental amalgam restorations (dental amalgam alloy as a free-flowing powder supplied in bulk masses, dental amalgam alloy powder supplied as compressed tablets and dental mercury sachets) are within the scope of ISO 24234.

Dentistry — Pre-capsulated dental amalgam