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Portable hemodialysis

Portable hemodialysis, Total:175 items.

The international standard classification for "Portable hemodialysis" includes: Surgical instruments and materials , Implants for surgery, prosthetics and orthotics , Transfusion, infusion and injection equipment .

The Chinese standard classification for "Portable hemodialysis" includes: Extracorporeal circulation, artificial organ and prosthesis device , Sanitation in general .


Professional Standard - Medicine

  • YY/T 1545-2017 Evaluation of connection between haemodialysis concentrate and haemodialysis equipment
  • YY 0054-2003 Haemodialysis、haemodiafiltration and haemofiltration equipment
  • YY/T 1920-2023 Blood compatibility tests of haemodialysers
  • YY 0267-2016 Hemodialysis and related therapies―Extracorporeal blood circuit for blood purification devices
  • YY 0054-2010 Haemodialysis equipment
  • YY 0053-2008 Cardiovascular implants and artificial organs—Haemodialysers haemodiafilters haemofilters and haemoconcentrators
  • YY 0053-2016 Hemodialysis and relavant therapics -Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Jilin Provincial Standard of the People's Republic of China

  • DB22/T 2196-2014 Specifications for quality control of water for hemodialysis and hemodialysis fluid

Taiwan Provincial Standard of the People's Republic of China

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

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

  • GB/T 13074-1991 Terms of blood purification Hemodialysis and hemofiltration

国家药监局

National Metrological Technical Specifications of the People's Republic of China

  • JJF 1353-2024 Calibration Specification for Haemodialysis Equipment
  • JJF 1353-2012 Calibeation Specification for Hemodialysis Equipment

SCC

  • BS 7126-101:1991 Urine collection bags-Specification for body-worn and non-body-worn bags
  • ISO/DIS 13959:1997 Water for Haemodialysis or Haemodiafiltration - Requirements
  • ISO/DIS 13958:1997 Concentrates for Haemodialysis or Haemodiafiltration
  • BS 7297-1:1990 Haemodialysers and related equipment-Specification for haemodialysers, haemofilters and haemoconcentrators
  • NS-EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
  • CAN/CSA Z364.1.1/Z364.1.2-1994(R2006) Haemodialysers, Haemofilters and Haemoconcentrators/ Extracorporeal Blood Circuit for Haemodialysers, Haemofilters and Haemoconcentrators
  • AAMI RD16:2007 Cardiovascular implants and artificial organs - Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
  • DANSK DS/EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems – Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • AAMI RD5:2003(R2008) Hemodialysis Systems
  • DANSK DS/EN ISO 8637-1:2021 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • CAN/CSA-Z364.1.1-1994(C2006) Hemodialyzers, hemofilters and hemoconcentrators
  • CAN/CSA-Z364.1.1-1994(R2006) Haemodialysers, Haemofilters and Haemoconcentrators
  • CAN 3-Z364.1.1-M84-1984 Hemodialyzers, hemofilters and hemoconcentrators
  • AAMI/ISO 8637-1:2017 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • AAMI/ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • AAMI RD61:2006 Concentrates for hemodialysis
  • AAMI/ISO RD17:2007 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
  • DANSK DS/EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems – Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • DIN EN ISO 8637 E:2013 Draft Document - Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010); German version FprEN ISO 8637:2013
  • NS-EN ISO 8637-1:2020 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
  • CAN/CSA-ISO 8637-2-2021 Extracorporeal systems for blood purification – Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018, IDT)
  • AENOR UNE-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
  • DANSK DS/EN ISO 8637-2:2018 Extracorporeal systems for blood purification – Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
  • BS 7297-2:1990 Haemodialysers and related equipment-Specification for extracorporeal circuits for use with haemodialysers, haemofilters and haemoconcentrators
  • CAN/CSA-Z364.1.2-1994(R2006) Extracorporeal Blood Circuit for Haemodialysers, Haemofilters and Haemoconcentrators
  • NS-EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
  • NS-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
  • CAN/CSA-ISO 8637-1-2021 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017, IDT)
  • DIN EN ISO 8637-1 E:2016 Draft Document - Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/DIS 8637-1:2016); German and English version prEN ISO 8637-1:2016
  • AAMI RD52:2004 Dialysate for Hemodialysis (Includes A1:2007 and A2:2007)
  • DIN EN ISO 8638 E:2013 Draft Document - Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010); German version FprEN ISO 8638:2013
  • CAN/CSA-Z364.1.2-1994(C2006) Extracorporeal blood circuit for hemodialyzers, hemofilters and hemoconcentrators
  • AAMI RD47:2020 Reprocessing of hemodialyzers
  • DIN EN ISO 8637-2 E:2016 Draft Document - Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO/DIS 8637-2:2016); German and English version prEN ISO 8637-2:2016
  • CAN/CSA-ISO 11663-11:2011 Quality of dialysis fluid for haemodialysis and related therapies
  • AENOR UNE-EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
  • DANSK DS/EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies
  • NS-EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
  • AAMI 11663:2014 Quality of dialysis fluid for hemodialysis and related therapies
  • AAMI/ISO 11663:2009 Quality of dialysis fluid for hemodialysis and related therapies
  • CAN/CSA-C22.2 No.60601-2-16-2001(R2005) Medical Electrical Equipment - Part 2-16: Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment

CZ-CSN

  • CSN ISO 8637:1994 Haemodialysers, haemofilters and haemoconcentrators
  • CSN ISO 8638:1994 Extracorporeal blood circuit for haemodialysers,haemofilters and haemoconcentrators

Japanese Industrial Standards Committee (JISC)

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

Society of Automotive Engineers (SAE)

IETF - Internet Engineering Task Force

German Institute for Standardization

  • DIN EN 1283:1996 Hemodialyzers, hemodiafilters, hemofilters, hemoconcentrators and associated LJ blood tubing systems
  • 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
  • DIN EN ISO 8637 E:2013-06 Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodialysis filters, hemofilters and hemoconcentrators (draft)
  • DIN EN ISO 8638 E:2013-06 Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodiafilters and hemofilters for extracorporeal circulation (draft)
  • DIN EN ISO 8637-2:2018-12 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018); German version EN ISO 8637-2:2018 / Note: To be replaced by DIN EN ISO 8637-2 (2023-01).
  • DIN EN ISO 8637-1 E:2016-05 Extracorporeal systems for blood purification Part 1: Hemodialyzers, hemodialysis filters, hemofilters and hemoconcentrators (draft)
  • DIN EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
  • DIN EN ISO 8637-2:2024 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)
  • DIN EN ISO 8637-2 E:2016-05 Extracorporeal systems for blood purification Part 2: Extracorporeal blood circuits for hemodialyzers, hemodiafilters and hemofilters (draft)
  • DIN EN ISO 8637-2 E:2023-01 Extracorporeal systems for blood purification Part 2: Extracorporeal blood circuits for hemodialyzers, hemodiafilters and hemofilters (draft)
  • DIN EN ISO 8637-2:2023-01 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/DIS 8637-2:2022); German and English version prEN ISO 8637-2:2022 / Note: Date...
  • DIN EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010); German version EN ISO 8638:2014

Spanish Association for Standardization (UNE)

  • UNE-EN 1283:1996 HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS.
  • UNE 111-325-1989 Hemodialysis, blood filters and blood hubs
  • UNE-EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
  • UNE-EN ISO 8637-2:2019 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
  • UNE 111-301-1990 Characteristics of hemodialysis water
  • UNE-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
  • UNE 111-350-1989 Hemodialysis, extracorporeal circulation with blood filters and blood hubs
  • UNE 111301:1990 REQUIREMENTS OF WATER USED IN HEMODIALYSIS
  • UNE-EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
  • UNE-EN 60601-2-16:1999 MEDICAL ELECTRICAL EQUIPMENT. PART 2-16: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT.

Australian/New Zealand Standard (AU-AS/NZS)

  • AS/NZS 3200.2.16:1999 Medical electrical equipment - Particular requirements for safety - Haemodialysis, haemodiafiltration and haemofiltration equipment

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
  • DS/EN 60601-2-16/Corr.:2000 Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

International Organization for Standardization (ISO)

  • ISO 8637:2010 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO/DIS 8637-1 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO 8637:2004 Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO/CD 8637-1 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO/FDIS 8637-1:2023 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO 8637:1989 Haemodialysers, haemofilters and haemoconcentrators
  • ISO 8638:2010 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • ISO 8638:2004 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • ISO 8637-1:2024 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO 8637-1:2017 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • ISO/FDIS 8637-2:2023 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO 8638:1989 Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators
  • ISO 8637-2:2024 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO/DIS 8637-2 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies

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
  • ANSI/AAMI RD17-2007 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
  • ANSI/AAMI/ISO 8637:2010/A1:2013 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators - Amendment 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports
  • ANSI/AAMI 11663-2014 Quality of dialysis fluid for haemodialysis and related therapies

British Standards Institution (BSI)

  • BS EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • BS EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • BS EN ISO 8637-2:2018 Extracorporeal systems for blood purification. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • 23/30470631 DC BS ISO 8637-1. Extracorporeal systems for blood purification - Part 1. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • BS EN ISO 8637-2:2024 Extracorporeal systems for blood purification - Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • 16/30331650 DC BS EN ISO 8637-1. Extracorporeal systems for blood purification. Part 1. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • 22/30456450 DC BS EN ISO 8637-2. Extracorporeal systems for blood purification - Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • BS EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies

Association Francaise de Normalisation

  • NF S93-302*NF EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • NF EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
  • NF S93-303:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • NF EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
  • NF S93-302-1*NF EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1 : haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • NF S93-302-2*NF EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2 : extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

Canadian Standards Association (CSA)

  • CSA Z8637-08-CAN/CSA-2008 Cardiovascular implants and artificial organs ?Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • CSA ISO 8637-2:2021 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • CAN/CSA-ISO 8637:2012 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (First Edition)
  • CAN/CSA-ISO 8638:2013 Implants cardiovasculaires et systèmes extracorporels - Circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres (première édition)
  • CAN/CSA-ISO 8638:2012 Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (First Edition)
  • CSA ISO 8637-1:2021 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (Adopted ISO 8637-1:2017, first edition, 2017-11)
  • CAN/CSA-ISO 8637A:2015 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators AMENDMENT 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports (First Edition)

Korean Agency for Technology and Standards (KATS)

  • KS P 4907-2011 Haemodialysers, haemofilters and haemoconcentrators
  • KS P ISO 8637-2023 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • KS P ISO 8637-1-2023 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • KS P ISO 8637:2012 Cardiovascular implants and extracorporeal systems-Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • KS P 4907-2013 Haemodialysers, haemofilters and haemoconcentrators
  • KS P ISO 8638-2022 Cardiovascular implants and extracorporeal systems -Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • KS C IEC 60601-2-16:2002 Haemodialysis, haemodiafiltration and haemofiltration equipment
  • KS P ISO 8638:2012 Cardiovascular implants and extracorporeal systems -Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • KS P ISO 8637:2018 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • KS P ISO 11663-2022 Quality of dialysis fluid for haemodialysis and related therapies

AT-ON

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

GSO

  • GSO ISO 8637:2016 Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • OS GSO ISO 8637:2016 Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • BH GSO ISO 8637:2017 Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • OS GSO ISO 8638:2016 Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • BH GSO ISO 8638:2017 Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • GSO ISO 8638:2016 Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • BH GSO ISO 11663:2022 Quality of dialysis fluid for haemodialysis and related therapies
  • GSO ISO 11663:2021 Quality of dialysis fluid for haemodialysis and related therapies

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 ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
  • EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers@ haemodiafilters and haemofilters
  • FprEN ISO 8637-2 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/FDIS 8637-2:2023)

Indonesia Standards

  • SNI ISO 8638:2012 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • SNI ISO 11663:2011 Quality of dialysate solutions for hemodialysis and similar treatments

American National Standards Institute (ANSI)

  • ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • ANSI/AAMI/ISO 8637-1:2017 Extracorporeal systems for blood purification— Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ANSI/AAMI/ISO 8637-2:2018 Extracorporeal systems for blood purification— Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • ANSI/AAMI/ISO 8638:2010(2015) Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
  • ANSI/AAMI/ISO 8637AMD 1:2012 Hemodialyzers, haemodiafilters, haemofilters and haemoconcentrators - Amendment 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports
  • ANSI/AAMI/ISO 11663:2009 Quality of dialysis fluid for haemodialysis and related therapies
  • ANSI/AAMI/ISO 11663(Ed1):2009 Quality of dialysis fluid for haemodialysis and related therapies

BSI

  • DANSK DS/ISO 8637-1:2024 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • DANSK DS/ISO 8637-2:2024 Extracorporeal systems for blood purification – Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

KR-KS

  • KS P ISO 8637-2-2022 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • KS P ISO 8637-2018 Cardiovascular implants and extracorporeal systems — 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

CEN - European Committee for Standardization

  • EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers@ haemodiafilters and haemofilters

RU-GOST R

  • GOST R 52556-2006 Water for hemodialysis. Specifications
  • GOST R 50267.16-2003 Medical electrical equipment. Part 2. Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
  • GOST R 50267.16-1993 Medical electrical equipment. Part 2. Particular requirements for safety of haemodialysis equipment

Military Standards (MIL-STD)