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

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.

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.

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].

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.

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.

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.

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.

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.

This document provides terms, classifications, requirements and testing of portable dental equipment for use primarily by dental professionals in nonclinical settings. Part 1 of this document specifies terms, classifications, general requirements, and test methods. Specific requirements for certain types of portable dental equipment for use in nonclinical environments will be set forth in subsequent parts of this document. This document does not apply to fixed dental equipment, wearable equipment (such as head lamps and loops), mobile dental equipment, or portable dental equipment that is not designed to be used or disassembled in nonclinical environments. In addition, this document does not include requirements for fixed dental equipment (e.g., portable dental clinics for vehicles or containers) that can be installed in dental mobile medical facilities.