Standards Development

Scope

This technical specification gives information on the properties and medical uses of nitric oxide and guidance on medical equipment through which this gas passes before and after administration to the patient. This specification is primarily intended for those involved in the standardization and manufacture of such medical equipment and for those concerned with the practice of inhaled nitric oxide therapy.

Purpose

Nitric oxide for inhalation (NO) is regarded as a relatively new medicinal product for use in investigation and treatment of patients on a compassionate basis. Endogenous nitric oxide seems to be involved in the control and action of a great number of organ functions, including platelet aggregation, neurotransmission, and antitumour and antimicrobial activity, and not only in the control of vascular tone.

Nitric oxide in nitrogen is supplied as a ready to use mixture intended to be administered to patients together with oxygen using a suitable supply and delivery system. In this document concentrations of nitric oxide/nitrogen are given as ‘[less than or equal to]1000 [micro]l/l’(words used because symbols not accepted).

It is therefore essential to use equipment suitable for such small doses and an international standard would help achieve that aim.

CEN TC215 produced a guidance document CEN CR 13903 in 2000 followed by two technical Specifications CEN TS 14507 parts 1 and 2 for delivery systems and supply systems respectively published in 2003. As these systems are still in use CEN TC215 decided to offer these documents to ISO TC121 to update and develop as International Standards (or Technical Specification).