Hemodialysis machine registration

Hemodialysis machine registration, Total:366 items.

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

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

Professional Standard - Medicine

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

Jilin Provincial Standard of the People's Republic of China

DB22/T 2031-2014 Specifications for Quality Control of Hemodialysis Machines
DB22/T 2196-2014 Specifications for quality control of water for hemodialysis and hemodialysis fluid

未注明发布机构

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
DIN EN ISO 8637 E:2013-06 Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodialysis filters, hemofilters and hemoconcentrators (draft)
CSA ISO 8637-2:2021 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
CSA Z23500-3-2020 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
DIN EN ISO 8638 E:2013-06 Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodiafilters and hemofilters for extracorporeal circulation (draft)
DIN EN ISO 13959 E:2015-04 Water for hemodialysis and related treatments (draft)
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
ANSI/AAMI/ISO 8637-2:2018 Extracorporeal systems for blood purification— Part 2: 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 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies— Part 4: Concentrates for haemodialysis and related therapies
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
ANSI/AAMI/ISO 8638:2010(2015) Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
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
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 E:2016-05 Extracorporeal systems for blood purification Part 2: Extracorporeal blood circuits for hemodialyzers, hemodiafilters and hemofilters (draft)
DIN EN ISO 11663 E:2015-05 Quality of dialysate for hemodialysis and related treatments (draft)
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
CSA Z364.5-2017 Safety of installation and operation of hemodialysis and home peritoneal dialysis
DIN EN ISO 8637-1 E:2016-05 Extracorporeal systems for blood purification Part 1: Hemodialyzers, hemodialysis filters, hemofilters and hemoconcentrators (draft)

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/T 1730-2020 Hemodialysis catheter for single use
YY 0054-2023 Haemodialysis equipment

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 9706.2-2003 Medical electrical equipment—Part 2-16:Particular requirements for the safety of haemodialysis,haemodiafiltration and haemofiltration equipment
GB/T 13074-1991 Terms of blood purification Hemodialysis and hemofiltration

Professional Standard - Agriculture

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
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

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

JJF 1541-2015 Calibration Specification for Hemodialysis Equipment Tester
JJF 1353-2012 Calibeation Specification for Hemodialysis Equipment

Group Standards of the People's Republic of China

T/NBPIA 003-2020 Technical Specification for quality of hemodialysis water
T/NBPIA 010-2023 Clinical Practice Guidelines for Home Hemodialysis
T/CAMDI 103-2023 Hemodialysis IV catheter for single use
T/CAME 48-2022 Centre concentrate delivery system for haemodialysis
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/NBPIA 007-2021 Classification of hemodialyzer clinical performance

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

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 3250:2005 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 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
NS-EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
ISO/DIS 13958:1997 Concentrates for Haemodialysis or Haemodiafiltration
UNE-EN 1283:1996 HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS.
AAMI RD61:2006 Concentrates for hemodialysis
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)
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
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
CAN 3-Z364.1.1-M84-1984 Hemodialyzers, hemofilters and hemoconcentrators
CAN/CSA-Z364.1.1-1994(R2006) Haemodialysers, Haemofilters and Haemoconcentrators
AAMI/ISO 8637-1:2017 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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
AAMI 11663:2014 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/ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
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)
BS 7297-2:1990 Haemodialysers and related equipment-Specification for extracorporeal circuits for use with haemodialysers, haemofilters and haemoconcentrators
AS 3207:1981 Approval and test specification for haemodialysis machines
AAMI/ISO RD17:2007 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
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 TIR43:2021 Ultrapure dialysis fluid for hemodialysis and related therapies
AAMI TIR43:2011 Ultrapure dialysate for hemodialysis and related therapies
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
CSA Z364.2.1-1994(R2011) Fluid Supply and Monitoring Systems for Haemodialysis
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)
AAMI RD47:2020 Reprocessing of hemodialyzers
CSA Z364.2.1-M1986-1986 Fluid Supply and Monitoring Systems for Hemodialysis
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
NS-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
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
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
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
NS-EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
AENOR UNE-EN ISO 11663:2016 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
CAN/CSA-Z364.1.3-1998(C2014) Reuse of hemodialyzers
CAN/CSA-Z364.1.3-1998(R2014) Reuse of Haemodialysers
CAN/CSA Z364.1.3-1998(R2014) Reuse of Haemodialysers
CAN 3-Z364.1.2-M84-1984 Extracorporeal circuits for hemodialyzers, hemofilters and hemoconcentrators
AENOR UNE-EN 60601-2-16:1999 Electromedical equipment. Part 2-16: Particular requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration equipment.
AAMI/ISO 13959:2009 Water for hemodialysis and related therapies
AENOR UNE-EN 60601-2-16 CORR:2000 Electromedical equipment - Part 2-16: Particular requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration equipment.
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)
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)
AAMI 13959:2014 Water for hemodialysis 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)
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 13959:2015 Water for haemodialysis and related therapies
CAN/CSA-ISO 13959-11:2011 Water for haemodialysis and related therapies
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)
CSA Z364.5-2022 Safety of installation and operation of hemodialysis and home peritoneal dialysis
AENOR UNE-EN 13867+A1:2009 Concentrates for hemodialysis and related therapies.
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
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
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
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/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
AAMI/ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 3: Water for haemodialysis and related therapies
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...
08/30179595 DC BS ISO 13958. Concentrates for haemodialysis and related therapies
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
CAN/CSA-ISO 11663-2015 Quality of dialysis fluid for haemodialysis and related therapies (Adopted ISO 11663:2014, second edition, 2014-04-01)
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
NS-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)
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
13/30270468 DC BS ISO 13958. Concentrates for haemodialysis and related therapies

International Organization for Standardization (ISO)

ISO 8637-1:2024 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/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 8638:2004 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ISO 8637:2004 Cardiovascular implants and artificial organs - 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/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 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 23500-5:2011 Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ISO/DIS 8637-2 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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 13958:2014 Concentrates 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 13959:2009 Water for haemodialysis and related therapies
ISO 13959:2014 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/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/DIS 23500-3 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
ISO 13958:2009 Concentrates for haemodialysis and related therapies
ISO 13958:2002 Concentrates for haemodialysis and related therapies

ES-AENOR

UNE 111-325-1989 Hemodialysis, blood filters and blood hubs
UNE 111-350-1989 Hemodialysis, extracorporeal circulation with blood filters and blood hubs

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

AT-ON

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

Korean Agency for Technology and Standards (KATS)

KS P 4907-2013 Haemodialysers, 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 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 13959:2009 Water for haemodialysis and related therapies
KS P ISO 13959-2009(2019) Water for haemodialysis and related therapies
KS P ISO 13959-2021 Water for haemodialysis and related therapies
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 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 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

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
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 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
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 23500-4:2022-12 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 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 23500-5:2017 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 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 23500-3:2019-11 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 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

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
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 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 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 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 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 S93-301:2009 Concentrates for haemodialysis and related therapies.
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 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 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 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
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

ES-UNE

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 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)
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.)

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 8637-2:2024 Extracorporeal systems for blood purification - Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies. Quality of dialysis fluid for haemodialysis and related therapies
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 23500-4:2024 Preparation and quality management of fluids for haemodialysis and related therapies - Concentrates for haemodialysis and related therapies
BS EN ISO 23500-3:2024 Preparation and quality management of fluids for haemodialysis and related therapies - Water for haemodialysis and related therapies
BS ISO 13959:2014 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 ISO 13959:2009 Water for haemodialysis and related therapies
BS EN ISO 13959:2015 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 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 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies. Water for haemodialysis and related therapies
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 ISO 13958:2015 Concentrates for haemodialysis and related therapies
BS EN 13867:2002 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 ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies. 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 13867:2002+A1:2009 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
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)
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 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)
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]
CSA Z364.1.1/Z364.1.2-94-1994 Hemodialyseurs, Hemofiltres Et Hemoconcentrateurs Deuxieme Edition; Fiche No 1
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
CAN/CSA-ISO 13958:2015 Concentrates for haemodialysis and related therapies (Second Edition)
CSA Z364.2.1-2013 Monitoring systems for hemodialysis equipment (Third Edition)

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
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 11663:2021 Quality of dialysis fluid for haemodialysis and related therapies
BH GSO ISO 11663:2022 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

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)
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)
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)
EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies
EN 1283:1996 Haemodialysers, Haemodiafilters, Haemofilters, Haemoconcentrators and Their Extracorporeal Circuits

BSI

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

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

American National Standards Institute （ANSI)

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 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 13958:2009 Concentrates for hemodialysis and related therapies

US-FCR

FCR 21 CFR PART 607-2014 ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
FCR 21 CFR PART 607-2015 ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
FCR 21 CFR PART 607-2013 ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS

Standard Association of Australia （SAA）

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

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

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 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 8637-2018 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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 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

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 50267.16-2003 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
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

AENOR

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-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)

VN-TCVN

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

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 60601-2-16:2015 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis@ haemodiafiltration and haemofiltration equipment
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)

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

RO-ASRO

STAS 11327/9-1983 RUBBER STOPPERS FOR BLOOD, PLASMA AND SOLUTION BOTTLES FOR INJECTIONS AND PERFUSIONS Organic substances determination

GOST

GOST R 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

Others: