Helsevesen, teknikk

This International Standard gives the requirement for the permissible reduction in strength resulting from crevice corrosion of dental amalgam products that are within the scope of ISO 24234: Dentistry – Dental amalgam and ISO 20749: Dentistry – Pre-capsulated dental amalgam. It provides details of the test procedure for determining this.

This International Standard describes requirements for tooth-like colour representations made of ceramic materials used to determine the tooth colour in the patient’s mouth or to check the colour of dental prosthesis, which are referred to as shade guides (colour rings) in this standard. The coordinates of tooth colours in the colour space (colour coordinates) the specification of which is left to the manufacturers’ discretion as well as the colour deviations of ceramic and other masses or materials used in the manufacture of dental prosthesis do not fall into the scope of this standard. Resources for visualizing the colours of ceramic and other masses, e.g. mass shade guides and colour patterns for certain ceramic and other masses, do not fall into the scope of this International Standard. They can be manufactured from any materials and serve solely to illustrate the colour effect; they do not serve colour determination inside the mouth.

EN ISO 80601-2-13 was published in 2011. Amendment 1 to EN ISO 80601-2-13:2011 will update this standard with regard to references to IEC 60601-1:2005 (EN 60601-1:2006) and applicable collateral standards. The Amendment 1 also introduces technical modifications to clarify the relationship between this standard and IEC 60601-2-49 and to further specify accessories. It amends requirements on the following aspects, in part due to the publication of amendments that have been published in 2012 and 2013 respectively to IEC 60601-1:2005 and its collateral standards: — addition of a definition on interchangeable anaesthetic vapour delivery system; — marking the mass of mobile me equipment; — movement over a threshold; — rough handling test; — multiple socket-outlets; — specific requirements on anaesthetic gas delivery systems and anaesthetic breathing systems including instructions for use; — vapour concentration during and after oxygen flush; — inspiratory pause. Where appropriate, amendment 1 also includes modifications of specific informative annexes related to the amended requirements as listed above. Finally, minor editorial updates were made.