11.060 - Dentistry
ICS 11.060 Details
Dentistry
Dentalmedizin
Art dentaire
Zobozdravstvo
General Information
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This document specifies the classification, requirements and test methods for endodontic sealing materials used in dentistry.
This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and materials used for other endodontic sealing procedures including apexification, perforation filling, resorption treatment or retrograde root-end filling (Type 2).
The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not address or include requirements for vital pulp therapy.
This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations and internationally accepted pharmacopeias can be made.
NOTE 2 National requirements regarding sterilization processes, if available, can be used. Standards on methods of validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.
- Standard29 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the classification, requirements and test methods for endodontic sealing materials used in dentistry.
This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and materials used for other endodontic sealing procedures including apexification, perforation filling, resorption treatment or retrograde root-end filling (Type 2).
The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not address or include requirements for vital pulp therapy.
This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations and internationally accepted pharmacopeias can be made.
NOTE 2 National requirements regarding sterilization processes, if available, can be used. Standards on methods of validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.
- Standard29 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the shape, dimensions, material, performance requirements and labelling of seals for dental local anaesthetic cartridges intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.
- Standard7 pagesEnglish languagesale 15% off
This document specifies general requirements and test methods for metallic dental elevators. In addition, it specifies dimensional requirements for specific types of dental elevators such as Warwick James elevators, Cryer elevators, Coupland elevators, Bein elevators and Flohr elevators.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the classification, requirements and test methods for endodontic sealing materials used in dentistry. This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and materials used for other endodontic sealing procedures including apexification, perforation filling, resorption treatment or retrograde root-end filling (Type 2). The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not address or include requirements for vital pulp therapy. This document does not specify requirements or test methods for sterility. NOTE 1 Reference to applicable national regulations and internationally accepted pharmacopeias can be made. NOTE 2 National requirements regarding sterilization processes, if available, can be used. Standards on methods of validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.
- Standard20 pagesEnglish languagesale 15% off
- Standard20 pagesFrench languagesale 15% off
This document specifies general requirements and test methods for metallic dental elevators. In addition, it specifies dimensional requirements for specific types of dental elevators such as Warwick James elevators, Cryer elevators, Coupland elevators, Bein elevators and Flohr elevators.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies general requirements and test methods for metallic dental elevators. In addition, it specifies dimensional requirements for specific types of dental elevators such as Warwick James elevators, Cryer elevators, Coupland elevators, Bein elevators and Flohr elevators.
- Standard12 pagesEnglish languagesale 15% off
- Standard12 pagesFrench languagesale 15% off
This document specifies requirements and test methods for acid-base, dental cements intended for permanent cementation, lining and restoration. This document is not intended to address resin-modified water-based cements. This document is applicable to both hand-mixed and encapsulated cements for mechanical mixing. This document specifies limits for each of the properties according to whether the cement is intended for use as a luting agent, base or liner, restorative material or pit and fissure sealing cement.
- Standard37 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and test methods for total digestible fluoride content and a minimum soluble fluoride release potential in dental varnishes containing fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. This also specifies packaging and labelling requirements, including the instructions for use. This document covers fluoride varnishes to be applied by dental health care workers.
This document does not apply to fast acting topical fluoride products such as fluoride oral rinses.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and their test methods for sinus membrane elevators used during the placement of dental implants for sinus floor lifting. It also specifies the requirements for their marking and labelling.
- Standard12 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements for the dimensions of various endodontic obturating materials and the radiopacity for polymeric points, polymeric-coated thermoplastic obturating carriers, non-point-shaped thermoplastic obturating material, or combinations of the above used for obturation of a root canal system. It also specifies numerical and colour-coding systems for designating the sizes of preformed endodontic obturating points, a method for determining the melt mass-flow rate for injection material, and the requirements for marking, labelling, packaging and the instructions for use.
Dental endodontic obturating points are marketed as sterilized or non-sterilized. Sterility is not included in this document. Any claim that the product is sterile is the manufacturer's responsibility (see Table 3). This document does not apply to instruments or apparatus used with obturating materials that become plastic with heat or materials supporting a coronal restoration.
Clause 7 specifies marking, labelling and packaging, including the instructions for use. This document does not specify requirements or test methods for sterility. Reference to applicable national regulations, internationally accepted pharmacopoeia and standards for validating sterilization processes can apply.
- Standard28 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies an extensible markup language (XML) format to facilitate the transfer of dental case data and CAD/CAM data between software systems.
- Standard78 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements for the dimensions of various endodontic obturating materials and the radiopacity for polymeric points, polymeric-coated thermoplastic obturating carriers, non-point-shaped thermoplastic obturating material, or combinations of the above used for obturation of a root canal system. It also specifies numerical and colour-coding systems for designating the sizes of preformed endodontic obturating points, a method for determining the melt mass-flow rate for injection material, and the requirements for marking, labelling, packaging and the instructions for use.
Dental endodontic obturating points are marketed as sterilized or non-sterilized. Sterility is not included in this document. Any claim that the product is sterile is the manufacturer's responsibility (see Table 3). This document does not apply to instruments or apparatus used with obturating materials that become plastic with heat or materials supporting a coronal restoration.
Clause 7 specifies marking, labelling and packaging, including the instructions for use. This document does not specify requirements or test methods for sterility. Reference to applicable national regulations, internationally accepted pharmacopoeia and standards for validating sterilization processes can apply.
- Standard28 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies an extensible markup language (XML) format to facilitate the transfer of dental case data and CAD/CAM data between software systems.
- Standard78 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and their test methods for sinus membrane elevators used during the placement of dental implants for sinus floor lifting. It also specifies the requirements for their marking and labelling.
- Standard12 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies an extensible markup language (XML) format to facilitate the transfer of dental case data and CAD/CAM data between software systems.
- Standard70 pagesEnglish languagesale 15% off
- Standard73 pagesFrench languagesale 15% off
- Standard73 pagesFrench languagesale 15% off
This document specifies the requirements for the dimensions of various endodontic obturating materials and the radiopacity for polymeric points, polymeric-coated thermoplastic obturating carriers, non-point-shaped thermoplastic obturating material, or combinations of the above used for obturation of a root canal system. It also specifies numerical and colour-coding systems for designating the sizes of preformed endodontic obturating points, a method for determining the melt mass-flow rate for injection material, and the requirements for marking, labelling, packaging and the instructions for use. Dental endodontic obturating points are marketed as sterilized or non-sterilized. Sterility is not included in this document. Any claim that the product is sterile is the manufacturer's responsibility (see Table 3). This document does not apply to instruments or apparatus used with obturating materials that become plastic with heat or materials supporting a coronal restoration. Clause 7 08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E000000530065006300740069006F006E005F007300650063005F0037000000 specifies marking, labelling and packaging, including the instructions for use. This document does not specify requirements or test methods for sterility. Reference to applicable national regulations, internationally accepted pharmacopoeia and standards for validating sterilization processes can apply.
- Standard19 pagesEnglish languagesale 15% off
- Standard19 pagesFrench languagesale 15% off
This document specifies requirements and their test methods for sinus membrane elevators used during the placement of dental implants for sinus floor lifting. It also specifies the requirements for their marking and labelling.
- Standard4 pagesEnglish languagesale 15% off
- Standard4 pagesFrench languagesale 15% off
This document specifies physical and chemical requirements and test methods for oral rinses. It also specifies requirements on the accompanying information to be given in the manufacturer's instructions for use and on containers as well as the requirements for packaging. Common labelling aspects are specified in order to enhance international understanding and trade.
This document is not applicable to other delivery systems (e.g. mouth sprays, foams, powders). It is not intended to describe regulatory aspects, e.g. methods of prescription.
This document is not applicable to oral rinses available by prescription only.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
- Standard69 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements and test methods for air-powered and electrical-powered scaler handpieces and scaler tips, including piezo and magnetostrictive type ultrasonic scalers, operated as stand-alone items or connected to dental units, for use on patients. This document also contains specifications on manufacturers’ instructions, marking and packaging.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements and their test methods for elastomeric impression and bite registration materials.
- Standard41 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies polymers commonly used in manufacturing dental instruments.
It is applicable to polymers used to manufacture either an entire instrument or part of an instrument.
It is applicable to single-use and reusable dental instruments, whether they are connected to a power-driven system or not.
This document does not apply to oral appliances and devices (e.g. splints, mouthpieces, crowns, bridges, implants), to instruments used long-term in the mouth of the patient or to devices and instruments not made of polymers.
This document contains a selection of polymers suitable for use in the manufacture of dental instruments.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements and test methods for air-powered and electrical-powered scaler handpieces and scaler tips, including piezo and magnetostrictive type ultrasonic scalers, operated as stand-alone items or connected to dental units, for use on patients. This document also contains specifications on manufacturers’ instructions, marking and packaging.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
- Standard69 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements and test methods for air-powered and electrical-powered scaler handpieces and scaler tips, including piezo and magnetostrictive type ultrasonic scalers, operated as stand-alone items or connected to dental units, for use on patients. This document also contains specifications on manufacturers’ instructions, marking and packaging.
- Standard18 pagesEnglish languagesale 15% off
- Standard19 pagesFrench languagesale 15% off
This document specifies polymers commonly used in manufacturing dental instruments.
It is applicable to polymers used to manufacture either an entire instrument or part of an instrument.
It is applicable to single-use and reusable dental instruments, whether they are connected to a power-driven system or not.
This document does not apply to oral appliances and devices (e.g. splints, mouthpieces, crowns, bridges, implants), to instruments used long-term in the mouth of the patient or to devices and instruments not made of polymers.
This document contains a selection of polymers suitable for use in the manufacture of dental instruments.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements and their test methods for elastomeric impression and bite registration materials.
- Standard41 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
- Standard60 pagesEnglish languagesale 15% off
- Draft68 pagesFrench languagesale 15% off
This document specifies the requirements and their test methods for elastomeric impression and bite registration materials.
- Standard33 pagesEnglish languagesale 15% off
- Standard33 pagesEnglish languagesale 15% off
- Standard33 pagesEnglish languagesale 15% off
- Standard33 pagesFrench languagesale 15% off
- Standard33 pagesFrench languagesale 15% off
- Standard33 pagesFrench languagesale 15% off
This document specifies polymers commonly used in manufacturing dental instruments. It is applicable to polymers used to manufacture either an entire instrument or part of an instrument. It is applicable to single-use and reusable dental instruments, whether they are connected to a power-driven system or not. This document does not apply to oral appliances and devices (e.g. splints, mouthpieces, crowns, bridges, implants), to instruments used long-term in the mouth of the patient or to devices and instruments not made of polymers. This document contains a selection of polymers suitable for use in the manufacture of dental instruments.
- Standard6 pagesEnglish languagesale 15% off
- Standard6 pagesFrench languagesale 15% off
This document specifies requirements and test methods for acid-base, dental cements intended for permanent cementation, lining and restoration. This document is not intended to address resin-modified water-based cements. This document is applicable to both hand-mixed and encapsulated cements for mechanical mixing. This document specifies limits for each of the properties according to whether the cement is intended for use as a luting agent, base or liner, restorative material or pit and fissure sealing cement.
- Standard37 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and test methods for acid-base, dental cements intended for permanent cementation, lining and restoration. This document is not intended to address resin-modified water-based cements. This document is applicable to both hand-mixed and encapsulated cements for mechanical mixing. This document specifies limits for each of the properties according to whether the cement is intended for use as a luting agent, base or liner, restorative material or pit and fissure sealing cement.
- Standard29 pagesEnglish languagesale 15% off
- Standard29 pagesEnglish languagesale 15% off
- Standard30 pagesFrench languagesale 15% off
This document specifies requirements and test methods for the physical properties of powered toothbrushes in order to promote the safety of these products for their intended use.
There are different technologies of powered toothbrushes. Common features of those powered toothbrushes to which this document applies are:
— a battery;
— a motor;
— a mechanical or magnetic drive system;
— a moving brush head with tufted filaments.
Powered toothbrushes can have a moving brush head with different motions (e.g. oscillating-rotating, side-by-side), frequencies and velocities.
These types of electric toothbrushes are tested for safety in use by means of appropriate test procedures or clinical studies
The requirements listed in this document apply to all types of powered toothbrushes. However, there is a possibility that some requirements are not applicable for all types. For example, brush head plate retention can only be applied if the brush has a head portion that can detach from the brush shaft. In addition, for the filaments end-rounding requirements, this document does not apply to filament types that are very thin (less than 0,1 mm outside diameter) or have no sharp edges (e.g. tapered, feathered, with split tips or spherical cap) or non-synthetic filaments, where applying the end-rounding process is inappropriate or impossible.
This document is not applicable to other types of powered oral hygiene devices (such as powered interdental brushes) or manual toothbrushes.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines the requirements for developing and documenting the goals, limitations, target end users and target patient population for artificial intelligence (AI) and augmented intelligence (AuI) enabled 2D radiograph analysis software for dentistry applications. It outlines the requirements for appropriate training data, validation data, test data and annotation for the software to ensure that it achieves its intended goals, and is restricted to the aspects. This document does not cover the specific implementation details, and focuses on static (i.e. non-dynamic) AI/AuI.
- Standard21 pagesEnglish languagesale 10% offe-Library read for1 day
This document provides an opinion on the application of the classification rules in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices as they pertain to dental devices and accessories.
- Technical report23 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines the requirements for developing and documenting the goals, limitations, target end users and target patient population for artificial intelligence (AI) and augmented intelligence (AuI) enabled 2D radiograph analysis software for dentistry applications. It outlines the requirements for appropriate training data, validation data, test data and annotation for the software to ensure that it achieves its intended goals, and is restricted to the aspects. This document does not cover the specific implementation details, and focuses on static (i.e. non-dynamic) AI/AuI.
- Standard21 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines the requirements for developing and documenting the goals, limitations, target end users and target patient population for artificial intelligence (AI) and augmented intelligence (AuI) enabled 2D radiograph analysis software for dentistry applications. It outlines the requirements for appropriate training data, validation data, test data and annotation for the software to ensure that it achieves its intended goals, and is restricted to the aspects. This document does not cover the specific implementation details, and focuses on static (i.e. non-dynamic) AI/AuI.
- Standard13 pagesEnglish languagesale 15% off
- Standard14 pagesFrench languagesale 15% off
This document provides an opinion on the application of the classification rules in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices as they pertain to dental devices and accessories.
- Technical report23 pagesEnglish languagesale 10% offe-Library read for1 day
This document describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.
- Standard26 pagesEnglish languagesale 10% offe-Library read for1 day
This document describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.
- Standard26 pagesEnglish languagesale 10% offe-Library read for1 day
This document describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.
- Standard18 pagesEnglish languagesale 15% off
- Standard18 pagesFrench languagesale 15% off
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard1 pageEnglish languagesale 15% off
- Standard1 pageFrench languagesale 15% off
- Standard1 pageFrench languagesale 15% off
This document specifies the requirements and tests for the duplicating materials used in dentistry which are primarily intended for forming flexible moulds needed to produce positive refractory investment copies of properly blocked-out master models.
- Standard38 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements and tests for the duplicating materials used in dentistry which are primarily intended for forming flexible moulds needed to produce positive refractory investment copies of properly blocked-out master models.
- Standard38 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements and tests for the duplicating materials used in dentistry which are primarily intended for forming flexible moulds needed to produce positive refractory investment copies of properly blocked-out master models.
- Standard30 pagesEnglish languagesale 15% off
- Standard31 pagesFrench languagesale 15% off
This document specifies the requirements, recommendations and the corresponding test methods for dental ceramic materials for fixed all-ceramic and metal-ceramic restorations and prostheses.
- Standard40 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements, recommendations and the corresponding test methods for dental ceramic materials for fixed all-ceramic and metal-ceramic restorations and prostheses.
- Standard40 pagesEnglish languagesale 10% offe-Library read for1 day