Yhteinen Toimialaliitto

This document gives requirements on the handling, storage, processing and documentation of saliva specimens intended for human DNA examination during the pre-examination phase before a molecular examination is performed.This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.Dedicated measures that need to be taken for saliva collected on absorbing materiasl or by mouth washes are not described in this document. Neither are measures for preserving and handling of native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described.NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Revised Annex ZA

This part of ISO 8536 specifies the requirements for infusion sets that use light-protective agents in the fluid path materials (abbreviated as "light-protective infusion sets” henceforth).This document also provides guidelines for performance and quality specifications of materials used in light-protective infusion sets.

Applicable to the manufacture, and use in manufacture, of liquids for use in electronic cigarettes and similar vapour producing devices intended for the production of aerosol for consumption by inhalation. Applicable to liquids with or without nicotine content. The standard will specify the minimum safety and quality requirements for the manufacture of such liquids and for their filling and holding when used in the manufacture of prefilled electronic cigarette devices.