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Blood Concentrator Testing Requirements

Blood Concentrator Testing Requirements, Total:60 items.

The international standard classification for "Blood Concentrator Testing Requirements" includes: Surgical instruments and materials .

The Chinese standard classification for "Blood Concentrator Testing Requirements" includes: Extracorporeal circulation, artificial organ and prosthesis device .


Taiwan Provincial Standard of the People's Republic of China

  • CNS 14194-1998 Extracorporeal blood circuit for haemodialysers hasmofilters and haemoconcentrators
  • CNS 14193-1998 Haemodialysers,hasmofilters and haemoconcentrators

Professional Standard - Medicine

  • YY 0053-2016 Hemodialysis and relavant therapics -Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • YY 0053-2008 Cardiovascular implants and artificial organs—Haemodialysers haemodiafilters haemofilters and haemoconcentrators

未注明发布机构

  • CAN/CSA-Z8637-2008 Cardiovascular Implants and Artificial Organs - Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators
  • DIN EN 1283:1996 Hemodialyzers, hemodiafilters, hemofilters, hemoconcentrators and associated LJ blood tubing systems

RU-GOST R

  • GOST R ISO 8637-1999 Haemodialysers, haemofilters and haemoconcentrators. Technical requirements and test methods
  • GOST R ISO 8638-1999 Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators. Technical requirements and test methods
  • GOST ISO 8637-2012 Haemodialysers, haemofiltres and haemoconcentrators. Technical requirements and test methods
  • GOST ISO 8638-2012 Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemoconcentrators. Technical requirements and test methods

SCC

Korean Agency for Technology and Standards (KATS)

  • KS P 4907-2013 Haemodialysers, haemofilters and haemoconcentrators
  • KS P ISO 8637:2012 Cardiovascular implants and extracorporeal systems-Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • KS P ISO 8638:2012 Cardiovascular implants and extracorporeal systems -Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • KS P ISO 8637-1-2023 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

International Organization for Standardization (ISO)

  • ISO 8637:1989 Haemodialysers, haemofilters and haemoconcentrators
  • ISO 8638:1989 Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators
  • ISO/FDIS 8637-1:2023 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO/DIS 8637-1 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO/CD 8637-1 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO 8637:2010 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO 8637:2004 Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

European Committee for Standardization (CEN)

  • EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
  • EN 1283:1996 Haemodialysers, Haemodiafilters, Haemofilters, Haemoconcentrators and Their Extracorporeal Circuits

Japanese Industrial Standards Committee (JISC)

  • JIS T 3250:2005 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • JIS T 3250:2011 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • JIS T 3250:2013 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • JIS T 3250:2022 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

IN-BIS

  • IS 13890-1994 Haemodialysers, haemofilters and haemoconcentrators - specification
  • IS 13878-1993 Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators - specification

Lithuanian Standards Office

  • LST EN 1283-2001 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits

Danish Standards Foundation

  • DS/EN 1283:1997 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
  • DS/EN ISO 8637-1:2021 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

British Standards Institution (BSI)

  • BS EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
  • BS EN ISO 8637-1:2020 Extracorporeal systems for blood purification. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • BS EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

AT-ON

  • ONORM EN 1283-1996 Haemodialysers,haemodiafilters,haemofilters,haemoconcentrators and their extracorporeal circuits

Canadian Standards Association (CSA)

US-AAMI

  • ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ANSI/AAMI RD16-2007 Cardiovascular implants and artificial organs-Hemodialyzers,hemodiafilters,hemofilters,and hemoconcentrators

ES-UNE

  • UNE-EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)

Association Francaise de Normalisation

  • NF EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
  • NF S93-302*NF EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

German Institute for Standardization

  • DIN EN ISO 8637-1:2020-10 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017); German version EN ISO 8637-1:2020

GSO

  • OS GSO ISO 8637:2016 Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • GSO ISO 8637:2016 Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators