DD CEN/TS 14507-1:2003

This standard DD CEN/TS 14507-1:2003 Inhalational nitric oxide systems is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment

This Part of CEN/TS 14507 refers to EN 60601‑1:1990 "Medical electrical equipment — Part 1: General requirements for safety", as amended by its amendments 1 (1991) and 2 (1995). For brevity Part 1 is referred to in this Part of CEN/TS 14507 either as the General Standard or as the General requirements.

The scope given in clause 1 of the General Standard applies except that 1.1 is replaced by the following:

1.1 This Part of CEN/TS 14507 specifies particular requirements for inhalational nitric oxide delivery systems and their modules. It covers devices which can be supplied in combined units, integrated into another medical device, for example a lung ventilator, or as individual devices.

This Part of CEN/TS 14507 addresses the monitoring of nitric oxide and oxygen delivery to the patient and minimization of the production of nitrogen dioxide.

This Part of CEN/TS 14507 covers the requirements for inhalational nitric oxide delivery systems intended for medical use, for example, in critical care, anaesthesia, and emergency/transport environments.

NOTE It is recognized that from time to time innovations and designs will appear that offer advantages and yet are not covered by specific safety-related design or performance aspects of this Part of CEN/TS 14507; such innovations are not to be discouraged. As the techniques and technologies in these innovations advance, it is essential that the safety objectives of this Part of CEN/TS 14507 are considered as minimum requirements.

The requirements of clause 1.3 of the General Standard apply with the following additions:

The numbering of clauses and subclauses of this Part of CEN/TS 14507 corresponds to that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words:

´Replacement´ means that the clause or subclause of the General Standard is replaced completely by the text of this Part of CEN/TS 14507.

´Addition´ means that the text of this Part of CEN/TS 14507 is additional to the requirements of the General Standard.

´Amendment´ means that the clause or subclause of the General Standard is amended as indicated by the text of this Part of CEN/TS 14507.

Subclauses or figures which are additional to those of the General Standard are numbered starting from 101. Additional annexes are lettered AA, BB, etc. and additional items aa), bb), etc.

The term ´this Standard´ is used to make reference to the General Standard and this Part of CEN/TS 14507 taken together.

Where there is no corresponding section, clause or subclause in this Part of CEN/TS 14507, the section, clause or subclause of the General Standard applies without modification.

Where it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Part of CEN/TS 14507.