Hälso- och sjukvård

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: CEN
Svarsdatum: den 16 apr 2026
Se merSe mindre
 
Ämnesområden: Tandvårdsmaterial
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: CEN
Svarsdatum: den 24 apr 2026
Se merSe mindre
 

This document specifies a test method for measuring the forces needed for the placement and removal of dental attachments (frictional retention elements of ball head-, snap-on, prefabricated telescopic and bar systems used for the attachment, support and stabilization of crowns and bridges, single attachments, removable partial dentures, complete dentures, and other superstructures on dental implant systems (including monopart implants)and, if not other justified, on natural teeth and root post copings). If not otherwise justified, this document can also be used for tests on custom-made or patient matched devices (e.g. laboratory manufactured). This test method is not applicable to retention devices for which normal placement and removal requires any off-axis rotation for the path of least resistance. This test method is not applicable to dental magnetic attachments, these are specified in ISO 13017.

Kommittébeteckning: SIS/TK 330/AG 09 (CEN TC 205, ISO TC 210 JWG 4, ISO TC 210 WG 5)
Källa: CEN
Svarsdatum: den 1 maj 2026
Se merSe mindre
 

ISO 10555-3:2013 specifies requirements for central venous catheters supplied in the sterile condition, and intended for single use.

Kommittébeteckning: SIS/TK 330/AG 09 (CEN TC 205, ISO TC 210 JWG 4, ISO TC 210 WG 5)
Källa: CEN
Svarsdatum: den 1 maj 2026
Se merSe mindre
 

ISO 10555-5:2013 specifies requirements for over-needle peripheral intravascular catheters, intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use.

Ämnesområden: Tandvårdsutrustning
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: CEN
Svarsdatum: den 4 maj 2026
Se merSe mindre
 

This document specifies general requirements and test methods for endodontic instruments used for endodontic purposes, e.g. enlargers, compactors, accessory instruments, shaping and cleaning instruments, and a numeric coding system. In addition, it covers general size designations, color-coding, packaging, and identification symbols.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 9 maj 2026
Se merSe mindre
 

This document specifies dimensions and requirements for both open and closed suction catheters made of flexible materials and intended for use in suctioning of the respiratory tract. Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this document. NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 19 maj 2026
Se merSe mindre
 

ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to 9. ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022. ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

Ämnesområden: Tandvårdsutrustning
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: CEN
Svarsdatum: den 23 maj 2026
Se merSe mindre
 

This document specifies requirements, test methods, and labeling for protective filtering devices intended for protection against retinal blue light exposure from powered polymerization activators in the scope of ISO 10650:2018, i.e., powered polymerization activators using quartz-tungsten halogen lamps or light emitting diodes (LED) to activate polymerization. This document does not apply to protective filtering devices for lasers or plasma arc devices.

Ämnesområden: Tandvårdsutrustning
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: CEN
Svarsdatum: den 23 maj 2026
Se merSe mindre
 

This document specifies the general requirements and test methods for steel and carbide rotary instruments used in dentistry, including designation, colour code and a quality control for these instruments. It applies to all types of steel and carbide rotary instruments independent of type and shape.

Ämnesområden: Tandvårdsmaterial
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: CEN
Svarsdatum: den 29 maj 2026
Se merSe mindre
 

ISO 29022:2013 specifies a shear test method used to determine the adhesive bond strength between direct dental restorative materials and tooth structure, e.g. dentine or enamel. The method as described is principally intended for dental adhesives. The method includes substrate selection, storage and handling of tooth structure, as well as the procedure for testing.