YY/T 1414-2016
Active
Industry standards-Medicine
YY/T 1414-2016 Liquid line solenoid valve for haemodialysis equipment
YY/T 1414-2016 Liquid line solenoid valve for haemodialysis equipment
Basic Information
Standard Code:
YY/T 1414-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2016-03-23
Implement Date:
2017-01-01
Pages:
8 pages
Scope
This standard specifies the technical requirements for electromagnetic valves used in the fluid path of hemodialysis equipment in terms of biological evaluation, mechanical performance, electrical performance, corrosion resistance, and lifespan.
This standard applies to electromagnetic valves (hereinafter referred to as "electromagnetic valves") that are in direct contact with dialysate or reverse osmosis water inside hemodialysis equipment. It does not apply to electromagnetic valves that are not in contact with liquids.
Note: This standard is applicable to quality control during the procurement, R&D, production, and use processes of hemodialysis equipment manufacturers.
Development Information
Referenced Standards
GB/T 13074-2009 Terms of blood purification
GB 4208-1993 Degrees of protection provided by enclosure (IP code)
GB/T 4208-2008 Degrees of protection provided by enclosure(IP code)
GB/T 4208-2017 Degrees of protection provided by enclosure(IP code)
GB 9706.2-2003 Medical electrical equipment—Part 2-16:Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
Related Standards
GB 12264-1990
Replaced
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced