BS DD CEN/TS 14507-1:2003
Inhalational nitric oxide systems. Delivery systems

Standard No.

BS DD CEN/TS 14507-1:2003

Release Date

2003

Published By

British Standards Institution (BSI)

Latest

BS DD CEN/TS 14507-1:2003

Scope

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.

BS DD CEN/TS 14507-1:2003 Referenced Document

• EN 12598 Oxygen Monitors for Patient Breathing Mixtures - Particular Requirements Ratified European Text
• EN 13221 High-Pressure Flexible Connections for Use with Medical Gases
• EN 475 Medical Devices - Electrically-Generated Alarm Signals
• EN 60068-2-64:1994 Environmental testing Part 2: Test methods Test Fh: Vibration, broad-band random (digital control) and guidance (IEC 68-2-64:1993 + corrigendum 1993)
• EN 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability*， 2010-04-01 Update
• EN 60601-1:1990 Medical Electrical Equipment Part 1: General Requirements for Safety Includes Amendments A1:1993, A11:1993, A12:1993, A2:1995 and A13:1996; Incorporates Corrigendum July 1994; Incorporates Corrigendum August 2005; IEC 60601-1:1988 + A1:1991 + A2:1995 + c
• EN 738-1:1997 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow metering devices (Incorporates Amendment A1: 2002)
• EN 738-3:1998 Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves Includes amendment A1: 2002
• EN 739:1998 Low-pressure hose assemblies for use with medical gases Includes Amendment A1: 2002

BS DD CEN/TS 14507-1:2003 history

• 2003 BS DD CEN/TS 14507-1:2003 Inhalational nitric oxide systems. Delivery systems