Hemodialysis machine

Hemodialysis machine, Total:370 items.

The international standard classification for "Hemodialysis machine" includes: Surgical instruments and materials , Implants for surgery, prosthetics and orthotics , Laboratory medicine , Other medical equipment , Transfusion, infusion and injection equipment .

The Chinese standard classification for "Hemodialysis machine" includes: Extracorporeal circulation, artificial organ and prosthesis device , Medical laboratory equipment , Sanitation in general .

Professional Standard - Medicine

YY 0572-2015 Water for haemodialysis and related therapies
YY/T 1920-2023 Blood compatibility tests of haemodialysers
YY 0053-2008 Cardiovascular implants and artificial organs—Haemodialysers haemodiafilters haemofilters and haemoconcentrators
YY 0572-2005 Water for haemodialysis and related therapies
YY 0053-2016 Hemodialysis and relavant therapics -Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
YY 0267-2016 Hemodialysis and related therapies―Extracorporeal blood circuit for blood purification devices
YY/T 0456.2-2014 Reagents for hematology analyzer―Part 2:Hemolysin
YY/T 1545-2017 Evaluation of connection between haemodialysis concentrate and haemodialysis equipment
YY/T 0598-2015 Concentrates for haemodialysis and related therapies
YY 0598-2015(A1) Concentrates for haemodialysis and related therapies
YY/T 0653-2017 Hematology analyzer
YY 0793.3-2023 Preparation and quality control of fluids for hemodialysis and related treatments - Part 3: Concentrates for hemodialysis and related treatments
YY 0054-2010 Haemodialysis equipment
YY 0054-2003 Haemodialysis、haemodiafiltration and haemofiltration equipment
YY/T 0653-2008 Hematology analyzer
YY/T 1414-2016 Liquid line solenoid valve for haemodialysis equipment
YY 0598-2015 Concentrates for haemodialysis and related therapies
YY 0598-2006 Concentrates for haemodialysis and related therapies
YY 0793.2-2023 Preparation and quality management of fluids for haemodialysis and related therapies--Part 2:Water for haemodialysis and related therapies

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
DB22/T 2031-2014 Specifications for Quality Control of Hemodialysis Machines

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
JJF 1541-2015 Calibration Specification for Hemodialysis Equipment Tester

国家药监局

YY/T 0793.4-2022 Preparation and quality management of fluids for hacmodialysis andrelated therapics—Part 1:Water treatment equipment for haemodialysis applications and related therapies
YY 0054-2023 Haemodialysis equipment
YY/T 0701-2021 Calibrator for hematology analyzer
YY/T 1730-2020 Hemodialysis catheter for single use

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

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
GB 9706.2-2003 Medical electrical equipment—Part 2-16:Particular requirements for the safety of haemodialysis,haemodiafiltration and haemofiltration equipment

Professional Standard - Agriculture

546药典化学药和生物制品卷-2010 Chapter 7 Drugs for the Urinary System Section 2 Dialysate for Blood Purification and Replacement Fluid Hemodialysate
548药典化学药和生物制品卷-2010 Chapter 7 Drugs for the Urinary System Section 2 Blood Purification Dialysate and Replacement Fluid Peritoneal Dialysate

Group Standards of the People's Republic of China

T/NBPIA 007-2021 Classification of hemodialyzer clinical performance
T/NBPIA 010-2023 Clinical Practice Guidelines for Home Hemodialysis
T/NBPIA 003-2020 Technical Specification for quality of hemodialysis water
T/CAMDI 103-2023 Hemodialysis IV catheter for single use
T/CNMIA 0002-2019 Evaluation criteria for independent hemodialysis centers
T/NBPIA 002-2020 Technical Specification for quality of dialysate and online hemodialysis replacement fluid
T/CAME 48-2022 Centre concentrate delivery system for haemodialysis

国家市场监督管理总局、中国国家标准化管理委员会

GB 9706.216-2021 Medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Association Francaise de Normalisation

NF S90-304:1989 MEDICO-SURGICAL EQUIPMENT. HAEMODIALYSIS EQUIPMENT. OPERATING DATA.
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
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
NF S93-303:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
NF EN ISO 23500-5:2019 Preparation and quality management of hemodialysis fluids and related therapies - Part 5: quality of dialysis fluids for hemodialysis and related therapies
NF S93-305-5*NF EN ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5 : quality of dialysis fluid for haemodialysis and related therapies
NF C74-322:2002 Medical electrical equipment - Part 2-16 : particular requirement for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment.
NF EN ISO 23500-4:2019 Preparation and quality management of hemodialysis fluids and related therapies - Part 4: concentrates for hemodialysis and related therapies
NF S93-315:2008 Fluids for hemodialysis - Requirements and user recommendations
NF EN ISO 23500-3:2019 Preparation and quality management of hemodialysis fluids and related therapies - Part 3: water for hemodialysis and related therapies
NF S93-305-3*NF EN ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3 : water for haemodialysis and related therapies
NF EN IEC 60601-2-16:2019 Medical electrical equipment - Part 2-16: particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration devices
NF S93-301:2009 Concentrates for haemodialysis and related therapies.
NF C74-322*NF EN IEC 60601-2-16:2019 Medical electrical equipment - Part 2-16 : particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
NF C74-322*NF EN 60601-2-16:2015 Medical electrical equipment - Part 2-16 : particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
NF S93-301/IN1:2009 Concentrates for haemodialysis and related therapies.
NF S93-305-4*NF EN ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4 : concentrates for haemodialysis and related therapies

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
JIS T 0601-2-16:2022 Medical electrical equipment -- Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

SCC

ISO/DIS 13959:1997 Water for Haemodialysis or Haemodiafiltration - Requirements
ISO/DIS 13958:1997 Concentrates for Haemodialysis or Haemodiafiltration
AAMI RD61:2006 Concentrates for hemodialysis
NS-EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
BS 7297-1:1990 Haemodialysers and related equipment-Specification for haemodialysers, haemofilters and haemoconcentrators
CAN/CSA Z364.1.1/Z364.1.2-1994(R2006) Haemodialysers, Haemofilters and Haemoconcentrators/ Extracorporeal Blood Circuit for Haemodialysers, Haemofilters and Haemoconcentrators
AAMI RD5:2003(R2008) Hemodialysis Systems
AAMI RD52:2004 Dialysate for Hemodialysis (Includes A1:2007 and A2:2007)
CAN/CSA-Z364.1.1-1994(C2006) Hemodialyzers, hemofilters and hemoconcentrators
AAMI RD16:2007 Cardiovascular implants and artificial organs - Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
AAMI/ISO 8637-1:2017 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
CAN 3-Z364.1.1-M84-1984 Hemodialyzers, hemofilters and hemoconcentrators
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(R2006) Haemodialysers, Haemofilters and Haemoconcentrators
DANSK DS/EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems – 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
CAN/CSA-ISO 11663-11:2011 Quality of dialysis fluid for haemodialysis and related therapies
AAMI/ISO 11663:2009 Quality of dialysis fluid for hemodialysis and related therapies
DANSK DS/EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies
AAMI 11663:2014 Quality of dialysis fluid for hemodialysis and related therapies
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)
AAMI/ISO RD17:2007 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
AAMI TIR43:2021 Ultrapure dialysis fluid for hemodialysis and related therapies
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)
AAMI TIR43:2011 Ultrapure dialysate for hemodialysis and related therapies
BS 7297-2:1990 Haemodialysers and related equipment-Specification for extracorporeal circuits for use with haemodialysers, haemofilters and haemoconcentrators
DANSK DS/EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems – Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
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)
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 E:2013 Draft Document - Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010); German version FprEN ISO 8637:2013
13/30270465 DC BS ISO 11663. Quality of dialysis fluid for haemodialysis and related therapies
08/30179572 DC BS ISO 11663. Quality of dialysis fluid for haemodialysis and related therapies
AENOR UNE-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
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
CSA Z364.2.1-1994(R2011) Fluid Supply and Monitoring Systems for Haemodialysis
NS-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
CSA Z364.2.1-M1986-1986 Fluid Supply and Monitoring Systems for Hemodialysis
AAMI RD47:2020 Reprocessing of hemodialyzers
CAN/CSA-Z364.1.2-1994(R2006) Extracorporeal Blood Circuit for Haemodialysers, Haemofilters and Haemoconcentrators
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-Z364.1.2-1994(C2006) Extracorporeal blood circuit for hemodialyzers, hemofilters and hemoconcentrators
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
AAMI/ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 5: Quality of dialysis fluid for haemodialysis and related therapies
AENOR UNE-EN ISO 11663:2016 Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
DANSK DS/ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 5: Quality of dialysis fluid for haemodialysis and related therapies
CAN/CSA-Z364.1.3-1998(R2014) Reuse of Haemodialysers
CAN/CSA Z364.1.3-1998(R2014) Reuse of Haemodialysers
CAN/CSA-Z364.1.3-1998(C2014) Reuse of hemodialyzers
NS-EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
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
AENOR UNE-EN 60601-2-16:1999 Electromedical equipment. Part 2-16: Particular requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration equipment.
AENOR UNE-EN 60601-2-16 CORR:2000 Electromedical equipment - Part 2-16: Particular requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration equipment.
CAN 3-Z364.1.2-M84-1984 Extracorporeal circuits for hemodialyzers, hemofilters and hemoconcentrators
NS-EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
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)
AAMI/ISO 13959:2009 Water for hemodialysis and related therapies
DANSK DS/EN ISO 13959:2015 Water for haemodialysis and related therapies
CAN/CSA-ISO 13959-11:2011 Water for haemodialysis and related therapies
AAMI 13959:2014 Water for hemodialysis and related therapies
NS-EN ISO 23500-5:2024 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024)
DANSK DS/EN ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
NS-EN ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
CSA Z364.5-2022 Safety of installation and operation of hemodialysis and home peritoneal dialysis
CEI EN IEC 60601-2-16:2019 Medical electrical equipment Part 2: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
DIN EN ISO 11663 E:2015 Draft Document - Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014); German and English version FprEN ISO 11663:2015
AENOR UNE-EN 13867+A1:2009 Concentrates for hemodialysis and related therapies.
AAMI/ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 4: Concentrates for haemodialysis and related therapies
DANSK DS/ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 3: Water for haemodialysis and related therapies
DANSK DS/ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 4: Concentrates for haemodialysis and related therapies
AAMI/ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 3: Water for haemodialysis and related therapies
AAMI/IEC 60601-2-16:2012 Medical electrical equipment, Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment
CAN/CSA-C22.2 No.60601-2-16-2014 Medical electrical equipment — Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
AAMI/IEC 60601-2-16:2008 Medical electrical equipment, Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment
DIN EN ISO 23500-5 E:2017 Draft Document - Guidance for the preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/DIS 23500-5:2017); German and English version prEN I...
DANSK DS/EN IEC 60601-2-16:2019 Medical electrical equipment – Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
DANSK DS/EN 60601-2-16:2015 Medical electrical equipment – Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
08/30179595 DC BS ISO 13958. Concentrates for haemodialysis and related therapies
CAN/CSA-C22.2 No.60601-2-16-2009 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
AAMI/IEC 60601-2-16:2018 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
13/30270468 DC BS ISO 13958. Concentrates for haemodialysis and related therapies

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-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
UNE 111301:1990 REQUIREMENTS OF WATER USED IN HEMODIALYSIS
UNE 111-350-1989 Hemodialysis, extracorporeal circulation with blood filters and blood hubs
UNE-EN ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
UNE-EN 60601-2-16:1999 MEDICAL ELECTRICAL EQUIPMENT. PART 2-16: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT.
UNE-EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
ISO/FDIS 23500-3:2023 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
UNE-EN ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019)
UNE-EN ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019)
UNE-EN IEC 60601-2-16:2019 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (Endorsed by Asociación Española de Normalización in July of 2019.)

Lithuanian Standards Office

LST EN 1283-2001 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
LST EN 60601-2-16+AC-2000 Medical electrical equipment -- Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:1998) )

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
DS/EN 60601-2-16:1999 Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

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 8637-2:2018-12 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 E:2013-06 Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodialysis filters, hemofilters and hemoconcentrators (draft)
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 8637-2:2024 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 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
DIN EN ISO 11663 E:2015-05 Quality of dialysate for hemodialysis and related treatments (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 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 23500-5:2019-11 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019); German version EN ISO 23500-5:2019 / Note: To be replaced by DIN EN ISO...
DIN EN ISO 23500-5:2022-12 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/DIS 23500-5:2022); German and English version prEN ISO 23500-5:2022 / Note: Date of is...
DIN EN ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
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
DIN EN ISO 23500-5:2024 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024)
DIN EN ISO 23500-5:2017 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/DIS 23500-5:2017); German and English version prEN ISO 23500-5:2017
DIN EN ISO 23500-4:2022-12 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO/DIS 23500-4:2022); German and English version prEN ISO 23500-4:2022 / Note: Date of issue 2022-11-1...
DIN EN ISO 8637-2:2018 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
DIN EN ISO 23500-4:2019-11 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019); German version EN ISO 23500-4:2019 / Note: To be replaced by DIN EN ISO 23500-4 (202...
DIN EN ISO 23500-3:2019-11 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019); German version EN ISO 23500-3:2019 / Note: To be replaced by DIN EN ISO 23500-3 (2022-12).
DIN EN ISO 23500-3:2022-12 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO/DIS 23500-3:2022); German and English version prEN ISO 23500-3:2022 / Note: Date of issue 2022-11-18*Inten...
DIN EN ISO 13959 E:2015-04 Water for hemodialysis and related treatments (draft)
DIN EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1:2013-04-01); German version EN ISO 8637:2014

AT-ON

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

International Organization for Standardization (ISO)

ISO/DIS 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 8637:2010 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637:1989 Haemodialysers, haemofilters and haemoconcentrators
ISO/CD 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 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 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies
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/FDIS 8637-2:2023 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for 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 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/DIS 23500-5 Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ISO/FDIS 23500-5:2011 Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ISO 8637:2010/Amd 1:2013 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
ISO 13958:2014 Concentrates for haemodialysis and related therapies
ISO 13959:2014 Water for haemodialysis and related therapies
ISO 13959:2009 Water for haemodialysis and related therapies
ISO 13959:2002 Water for haemodialysis and related therapies
ISO/DIS 23500-4 Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
ISO/DIS 23500-3 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
ISO/FDIS 23500-4:2011 Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
ISO 13958:2002 Concentrates for haemodialysis and related therapies
ISO 13958:2009 Concentrates for haemodialysis and related therapies

Korean Agency for Technology and Standards (KATS)

KS P ISO 8637-1-2023 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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 8637-2023 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P 4907-2011 Haemodialysers, haemofilters and haemoconcentrators
KS P ISO 11663-2022 Quality of dialysis fluid for haemodialysis and related therapies
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 13959-2021 Water for haemodialysis and related therapies
KS P ISO 13959:2009 Water for haemodialysis and related therapies
KS P ISO 13959-2009(2019) Water for haemodialysis and related therapies
KS C IEC 60601-2-16:2018 Medical electrical equipment — Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
KS P ISO 23500-3:2021 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
KS P ISO 8638-2012(2017) Cardiovascular implants and extracorporeal systems －Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
KS P ISO 23500-4:2021 Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
KS P ISO 8637:2018 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P ISO 13958:2009 Concentrates for haemodialysis and related therapies
KS P ISO 13958-2009(2019) Concentrates 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

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)
prEN ISO 8637-2 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/DIS 8637-2:2022)
prEN ISO 23500-5 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/DIS 23500-5:2022)
FprEN ISO 23500-5 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/FDIS 23500-5:2024)
EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies
EN 1283:1996 Haemodialysers, Haemodiafilters, Haemofilters, Haemoconcentrators and Their Extracorporeal Circuits

American National Standards Institute （ANSI)

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 11663:2009 Quality of dialysis fluid for haemodialysis and related therapies
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 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies—Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ANSI/AAMI/ISO 8638:2010(2015) Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ANSI/AAMI/ISO 11663(Ed1):2009 Quality of dialysis fluid for haemodialysis and related therapies
ANSI/AAMI/ISO 13959:2009 Water for hemodialysis and related therapies
ANSI/AAMI/ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies— Part 4: Concentrates for haemodialysis and related therapies
ANSI/AAMI/ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies—Part 3: Water for haemodialysis and related therapies
ANSI/AAMI/ISO 13958:2009 Concentrates for hemodialysis 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 11663-2014 Quality of dialysis fluid for haemodialysis and related therapies
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
AAMI RD62-2006 Water treatment equipment for hemodialysis application
ANSI/AAMI 13959-2014 Water for hemodialysis 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 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies
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 ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies
BS ISO 11663:2009 Quality of dialysis fluid for haemodialysis and related therapies
BS EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
BS EN ISO 23500-5:2024 Preparation and quality management of fluids for haemodialysis and related therapies - Quality of dialysis fluid for haemodialysis and related therapies
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
BS EN ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies. Quality of dialysis fluid for haemodialysis and related therapies
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 23500-3:2024 Preparation and quality management of fluids for haemodialysis and related therapies - Water for haemodialysis and related therapies
BS EN ISO 23500-4:2024 Preparation and quality management of fluids for haemodialysis and related therapies - Concentrates for haemodialysis and related therapies
BS ISO 13959:2014 Water for haemodialysis and related therapies
BS EN ISO 8637-1:2020 Extracorporeal systems for blood purification. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
BS ISO 13959:2009 Water for haemodialysis and related therapies
BS EN IEC 60601-2-16:2019 Medical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
BS EN ISO 13959:2015 Water for haemodialysis and related therapies
BS EN 60601-2-16:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
BS EN ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies. Water for haemodialysis and related therapies
BS EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
22/30449721 DC BS EN ISO 23500-5. Preparation and quality management of fluids for haemodialysis and related therapies - Part 5. Quality of dialysis fluid for haemodialysis and related therapies
BS EN 13867:2002 Concentrates for haemodialysis and related therapies
BS EN ISO 13958:2015 Concentrates for haemodialysis and related therapies
12/30254337 DC BS ISO 8637 AMD1. Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
BS EN 13867:2002+A1:2009 Concentrates for haemodialysis and related therapies
BS EN ISO 23500-2:2024 Preparation and quality management of fluids for haemodialysis and related therapies - Water treatment equipment for haemodialysis applications and related therapies
BS EN ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies. Concentrates for haemodialysis and related therapies

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)
CAN/CSA-ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies (Second Edition)
CSA Z23500-5-2020 Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
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)
CSA Z8638-08-CAN/CSA-2008 Cardiovascular implants and artificial organs ?Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters First Edition [Replaced: CSA Z364.1.1/Z364.1.2-94, CSA Z364.1.1/Z364.1.2-94]
CAN/CSA-Z8637-2008 Cardiovascular Implants and Artificial Organs - Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators
CSA Z364.5-2017 Safety of installation and operation of hemodialysis and home peritoneal dialysis
CSA Z364.1.1/Z364.1.2-94-1994 Hemodialyseurs, Hemofiltres Et Hemoconcentrateurs Deuxieme Edition; Fiche No 1
CSA Z23500-3-2020 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
CSA C22.2 No.60601-2-16-01-2001 Medical Electrical Equipment - Part 2-16: Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment Second Edition; IEC 60601-2-16:1998
CSA Z364.2.1-2013 Monitoring systems for hemodialysis equipment (Third Edition)
CAN/CSA-ISO 13958:2015 Concentrates for haemodialysis and related therapies (Second Edition)
CSA C22.2 No.60601-2-16-2019 Medical electrical equipment — Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
CAN/CSA-Z8638-2008 Cardiovascular Implants and Artificial Organs - Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters

GSO

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 8637:2016 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
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
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
BH GSO ISO 13959:2017 Water for haemodialysis and related therapies
BH GSO IEC 60601-2-16:2016 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
OS GSO IEC 60601-2-16:2014 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

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
SNI ISO 13959:2010 Water for haemodialysis and related therapies

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
AS/NZS IEC 60601.2.16:2015 Medical electrical equipment - Special requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment

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 11663-2017 Quality of dialysis fluid for haemodialysis and related therapies
KS P ISO 23500-5-2022 Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
KS C IEC 60601-2-16-2018 Medical electrical equipment — Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
KS P ISO 23500-4-2021 Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
KS P ISO 8637-2018 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P ISO 23500-3-2021 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
KS C IEC 60601-2-16-2022 Medical electrical equipment — Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

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
EN ISO 23500-5:2019 Preparation and quality management of f luids for haemodialysis and related therapies - Part 5: Quality of dialysis f luid for haemodialysis and related therapies
EN ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
EN ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies

IN-BIS

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

RU-GOST R

GOST R 52556-2006 Water for hemodialysis. Specifications
GOST R ISO 8637-1999 Haemodialysers, haemofilters and haemoconcentrators. Technical requirements and test methods
GOST ISO 8637-2012 Haemodialysers, haemofiltres and haemoconcentrators. Technical requirements and test methods
GOST R 50267.16-1993 Medical electrical equipment. Part 2. Particular requirements for safety of haemodialysis equipment
GOST R 50267.16-2003 Medical electrical equipment. Part 2. Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
GOST R IEC 60601-2-16-2016 Medical electrical equipment. Part 2-16. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration
GOST R ISO 8638-1999 Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators. Technical requirements and test methods
GOST R ISO 13958-2015 Concentrates for haemodialysis and related therapies
GOST ISO 8638-2012 Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemoconcentrators. Technical requirements and test methods

VN-TCVN

TCVN 7303-2-16-2007 Medical electrical equipment.Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

Standard Association of Australia （SAA）

AS 3207:1981 Approval and test specification for haemodialysis machines

International Electrotechnical Commission (IEC)

IEC 60601-2-16:2018 RLV Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
IEC 60601-2-16:2012 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

CENELEC - European Committee for Electrotechnical Standardization

EN 60601-2-16:1998 Medical Electrical Equipment Part 2-16: Particular Requirements for the Safety of Haemodialysis@ Haemodiafiltration and Haemofiltration Equipment (Incorporating Corrigendum December 1999)
EN 60601-2-16:2015 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis@ haemodiafiltration and haemofiltration equipment

European Committee for Electrotechnical Standardization（CENELEC）

EN IEC 60601-2-16:2019 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment