Development and application of the national standard for Pressure regulators for use with medical gases—Part 3:Pressure regulators integrated with cylinder valves(VIPRs)
WANG Yongyi
Abstract:The development of this national standard aims to solve the problem of the absence of product standards for pressure regulators integrated with cylinder valves in the domestic standard systems at all levels(excluding enterprise standards).This product is an integrated valve that is directly installed on gas cylinders,featuring functions of gas opening and closing,gas pressure reduction,pressure stabilization,and the ability to control gas output flow.Since the application of this type of product originated overseas and its introduction and promotion in China started relatively late,before the formulation of this standard,the manufacturing and inspection of the product mostly directly referred to ISO and CGA standards.In the case of foreign trade orders,it is also necessary to comply with the requirements of the EU MDD(MDR)and TPED regulations.This is the first time to formulate a national standard by transforming an international standard,with the object of transformation being ISO 10524-3:2019.During the transformation process,for the referenced standards that have been transformed into national standards,we have revised their standard numbers and names,and carefully checked their versions and applicability.We have carried out comprehensive discussions,verification,and validation work on the parts of the original standard with ambiguous expressions,omissions,and errors,making every effort to ensure that after the standard is issued,it has applicability,effectiveness,and operability in the actual implementation process.
Keywords:cylinder valvespressure regulatorsproduct standardsmedical devices
Publication Date:2025-08-28
Pages:10( 14-23 )
