1.1 This Part of CEN/TS 14507 applies to systems for the supply of nitric oxide/nitrogen mixtures to a
delivery and monitoring system complying with CEN/TS 14507-1 for treatment of one patient at a time, in a
healthcare facility.
1.2 This Part of CEN/TS 14507 applies to supply systems with cylinders at a filling pressure up to 20 000
kPa and concentrations up to 1000 μl/l of nitric oxide in nitrogen.
1.3 R This Part of CEN/TS 14507 does not apply to:
· pipeline systems for delivery of nitric oxide/nitrogen mixtures to more than one patient at a time;
· supply systems for nitric oxide/nitrogen mixtures intended for use in home care, emergency and transport.
BS DD CEN/TS 14507-2:2003 Referenced Document
EN 12218 Rail systems for supporting medical equipment Includes Amendment A1: 2002
EN 13221:2000 High-Pressure Flexible Connections for Use with Medical Gases
EN 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests*, 2015-09-01 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 837-1 Pressure gauges - Part 1: Bourdon tube pressure gauges - Dimensions, metrology, requirements and testing
EN 962 AMD prA2 Transportable Gas Cylinders - Valve Protection Caps and Valve Guards for Industrial and Medical Gas Cylinders - Design, Construction and Tests
EN ISO 14971 Medical devices - Application of risk management to medical devices (ISO 14971:2019)*, 2021-12-08 Update
ISO 14971:2000 Medical devices - Application of risk management to medical devices