blood cell analysis

blood cell analysis, Total:340 items.

The international standard classification for "blood cell analysis" includes: Laboratory medicine , Surgical instruments and materials , Implants for surgery, prosthetics and orthotics , Radiographic equipment , Medical Sciences and health care facilities in general , Transfusion, infusion and injection equipment , Animal feeding stuffs .

The Chinese standard classification for "blood cell analysis" includes: Medical laboratory equipment , Extracorporeal circulation, artificial organ and prosthesis device , Medical ultrasound, laser, high-frequency instrument and equipment , Animal quarantine, veterinary and epidemic prevention , Chemical Measurement , Sanitation in general , Livestock and poultry feed and additive .

Group Standards of the People's Republic of China

T/ZZB 1062-2019 Absorbable hemostatic particles
T/NBPIA 012-2024 Classification of angioplasty balloon catheter for hemodialysis access
T/CITS 143-2024 Requirements for blood cell analysis report
T/NBPIA 007-2021 Classification of hemodialyzer clinical performance

Professional Standard - Agriculture

空气和废气监测分析方法 6.5.1-2003 Chapter 6 Analysis of Organic Pollutants Chapter 5 Other Organic Compounds—Epichlorohydrin
空气和废气监测分析方法 6.5.8-2003 Chapter 6 Analysis of Organic Pollutants Chapter 5 Other Organic Compounds Octaphenyl Soluble Matter
空气和废气监测分析方法 4.2.4-2003 Part 4 Precipitation Monitoring Chapter 2 Precipitation Monitoring Analysis Method Tetranitrate
空气和废气监测分析方法 6.4.3-2003 Chapter 6 Analysis of Organic Pollutants Chapter 4 Aldehyde and Ketone Compound Triacetaldehyde
空气和废气监测分析方法 6.2.5-2003 Chapter 6 Analysis of Organic Pollutants Chapter 2 Aromatic Compounds Pentaphenylamine Compounds
空气和废气监测分析方法 4.2.8-2003 Part 4 Precipitation Monitoring Chapter 2 Precipitation Monitoring Analysis Methods Octaammonium Ion
空气和废气监测分析方法 6.5.6-2003 Chapter 6 Analysis of Organic Pollutants Chapter 5 Other Organic Compounds Hexahydrazine and Unsymmetrical Dimethylhydrazine
空气和废气监测分析方法 6.1.3-2003 Chapter 6 Analysis of Organic Pollutants Chapter 1 Volatile Organic Compound Trichlorobutadiene (B)
空气和废气监测分析方法 6.2.3-2003 Chapter 6 Analysis of Organic Pollutants Chapter 2 Aromatic Compounds Trinitrobenzene Compounds
空气和废气监测分析方法 6.1.6-2003 Part Six Analysis of Organic Pollutants Chapter One Volatile Organic Compound Hexamethanol
空气和废气监测分析方法 7.2.1-2003 Chapter 7 Chemical Mass Balance (CMB) Receptor Model and Its Application in Source Apportionment of Ambient Air Particulate Matter Chapter 2 Sample Collection of Atmospheric Particulate Matter Emission Sources—Classification of Particulate Matter Pollutio
空气和废气监测分析方法 6.2.2-2003 Part Six Analysis of Organic Pollutants Chapter Two Aromatic Compounds Dichlorobenzene Compounds
空气和废气监测分析方法 4.2.2-2003 Part 4 Precipitation Monitoring Chapter 2 Precipitation Monitoring Analysis Method 2 pH Value
空气和废气监测分析方法 4.2.10-2003 Part 4 Precipitation Monitoring Chapter 2 Precipitation Monitoring Analysis Methods Ten Calcium and Magnesium Ions
空气和废气监测分析方法 6.2.9-2003 Chapter 6 Analysis of Organic Pollutants Chapter 2 Aromatic Compounds
空气和废气监测分析方法 6.3.1-2003 Chapter 6 Analysis of Organic Pollutants Chapter 3 Pesticide Compounds - Organochlorine Pesticides and PCBs
空气和废气监测分析方法 6.3.3-2003 Chapter 6 Analysis of Organic Pollutants Chapter 3 Pesticide Compound Trichlorfon
空气和废气监测分析方法 6.5.7-2003 Part Six Analysis of Organic Pollutants Chapter Five Other Organic Compounds Seven Organic Sulfur Compounds
空气和废气监测分析方法 6.5.4-2003 Chapter 6 Analysis of Organic Pollutants Chapter 5 Other Organic Compounds Tetrapyridine
空气和废气监测分析方法 7.5.3-2003 Chapter 7 Chemical Mass Balance (CMB) Receptor Model and Its Application in Source Apportionment of Ambient Air Particulate Matter Chapter 5 Establishment of Particulate Matter Composition Spectrum Three Sources and Receptor Chemical Composition Scope
空气和废气监测分析方法 6.2.1-2003 Chapter 6 Analysis of Organic Pollutants Chapter 2 Aromatic Compounds-Benzene Series
空气和废气监测分析方法 6.5.5-2003 Chapter 6 Analysis of Organic Pollutants Chapter 5 Other Organic Compounds Methyl Pentaisocyanate
空气和废气监测分析方法 4.2.3-2003 Part 4 Precipitation Monitoring Chapter 2 Precipitation Monitoring Analysis Method Trisulfate
水和废水监测分析方法 3.6.5-2003 Part 3 Comprehensive Index and Inorganic Pollutants Chapter 6 Sediment Monitoring 5 Analysis of Sediment Samples
空气和废气监测分析方法 6.1.5-2003 Part Six Analysis of Organic Pollutants Chapter One Volatile Organic Compounds Five Total Hydrocarbons and Non-Methane Hydrocarbons
空气和废气监测分析方法 7.5.2-2003 Part Seven Chemical Mass Balance (CMB) Receptor Model and Its Application in Source Apportionment of Ambient Air Particulate Matter
空气和废气监测分析方法 4.2.6-2003 Part 4 Precipitation Monitoring Chapter 2 Precipitation Monitoring Analysis Methods Hexachloride Ion
空气和废气监测分析方法 7.4.2-2003 Part Seven Chemical Mass Balance (CMB) Receptor Model and Its Application in Source Apportionment of Ambient Air Particles Chapter Four Analytical Methods of Source and Receptor Samples Two Analytical Techniques of Source and Receptor Samples
空气和废气监测分析方法 4.2.1-2003 Part 4 Precipitation Monitoring Chapter 2 Precipitation Monitoring Analysis Method 1 Conductivity
空气和废气监测分析方法 6.1.2-2003 Chapter 6 Analysis of Organic Pollutants Chapter 1 Volatile Organic Compounds Divolatile Halogenated Hydrocarbons
空气和废气监测分析方法 6.1.4-2003 Chapter 6 Analysis of Organic Pollutants Chapter 1 Volatile Organic Compounds Tetrachlorethylene
空气和废气监测分析方法 6.4.4-2003 Chapter 6 Analysis of Organic Pollutants Chapter 4 Aldehydes and Ketone Compounds Tetraacrolein
空气和废气监测分析方法 6.2.6-2003 Part Six Analysis of Organic Pollutants Chapter Two Aromatic Compounds Hexaphthalate Compounds
空气和废气监测分析方法 6.3.5-2003 Chapter 6 Analysis of Organic Pollutants Chapter 3 Pesticide Compounds 5 Organophosphorus Pesticides
空气和废气监测分析方法 6.2.8-2003 Chapter 6 Analysis of Organic Pollutants Chapter 2 Aromatic Compounds Octabenzo[a]pyrene
空气和废气监测分析方法 6.4.6-2003 Chapter 6 Analysis of Organic Pollutants Chapter 4 Aldehydes and Ketones Hexaacetone
空气和废气监测分析方法 6.5.9-2003 Chapter 6 Analysis of Organic Pollutants Chapter 5 Other Organic Compounds 9 Odor
空气和废气监测分析方法 6.4.1-2003 Chapter 6 Analysis of Organic Pollutants Chapter 4 Aldehydes and Ketones-Aldehydes and Ketones
空气和废气监测分析方法 4.2.11-2003 Part 4 Precipitation Monitoring Chapter 2 Precipitation Monitoring Analysis Methods Undecaproic Acid Acetic Acid
空气和废气监测分析方法 7.5.4-2003 Part Seven Chemical Mass Balance (CMB) Receptor Model and Its Application in Source Apportionment of Ambient Air Particles Chapter Five Particle Composition Spectrum Establishment Four Source and Receptor Composition Spectrum Data Evaluation
空气和废气监测分析方法 6.5.2-2003 Chapter 6 Analysis of Organic Pollutants Chapter 5 Other Organic Compounds Diacrylonitrile
空气和废气监测分析方法 4.2.7-2003 Part 4 Precipitation Monitoring Chapter 2 Precipitation Monitoring Analysis Methods Heptafluoride Ion
空气和废气监测分析方法 6.1.1-2003 Chapter 6 Analysis of Organic Pollutants Chapter 1 Volatile Organic Compounds - Volatile Organic Compounds (VOCs)
空气和废气监测分析方法 7.5.1-2003 Chapter 7 Chemical Mass Balance (CMB) Receptor Model and Its Application in Source Apportionment of Ambient Air Particulate Matter
空气和废气监测分析方法 7.2.2-2003 Chapter 7 Chemical Mass Balance (CMB) Receptor Model and Its Application in Source Apportionment of Ambient Air Particulate Matter Chapter 2 Sample Collection of Atmospheric Particulate Matter Emission Sources 2 Other Classification Methods
空气和废气监测分析方法 4.2.9-2003 Part 4 Precipitation Monitoring Chapter 2 Precipitation Monitoring Analysis Methods Nine Potassium and Sodium Ions
空气和废气监测分析方法 6.2.7-2003 Part Six Analysis of Organic Pollutants Chapter Two Aromatic Compounds Seven Polycyclic Aromatic Hydrocarbons
空气和废气监测分析方法 6.3.4-2003 Chapter 6 Analysis of Organic Pollutants Chapter 3 Pesticide Compounds Tetrachlorfon and Dichlorvos
空气和废气监测分析方法 6.4.5-2003 Part Six Analysis of Organic Pollutants Chapter Four Aldehydes and Ketones Compounds Penta-low Molecular Aldehydes
空气和废气监测分析方法 6.3.2-2003 Chapter 6 Analysis of Organic Pollutants Chapter 3 Pesticide Compound Dimethyl Parathion
空气和废气监测分析方法 6.4.2-2003 Chapter 6 Analysis of Organic Pollutants Chapter 4 Aldehydes and Ketones Diformaldehyde
空气和废气监测分析方法 7.4.1-2003 Chapter 7 Chemical Mass Balance (CMB) Receptor Model and Its Application in Source Apportionment of Ambient Air Particulates Chapter 4 Analytical Methods of Source and Receptor Samples—Weighing of Filter
空气和废气监测分析方法 4.2.5-2003 Part 4 Precipitation Monitoring Chapter 2 Precipitation Monitoring Analysis Methods Pentanitrite
水和废水监测分析方法 3.6.6-2003 Part Three Comprehensive Indicators and Inorganic Pollutants Chapter Six Bottom Monitoring Six Analysis of Organic Pollutants in Bottom
空气和废气监测分析方法 6.5.3-2003 Chapter 6 Analysis of Organic Pollutants Chapter 5 Other Organic Compounds Trimethylamine
空气和废气监测分析方法 6.2.4-2003 Chapter 6 Analysis of Organic Pollutants Chapter 2 Aromatic Compounds Tetraphenolic Compounds

Professional Standard - Medicine

YY/T 0701-2021 Calibrator for hematology analyzer
YY/T 0456.2-2014 Reagents for hematology analyzer―Part 2:Hemolysin
YY/T 0702-2008 Control material for hematology analyzer
YY/T 0456.2-2003 Regents for hematology analyzer use - Part 2: Hemolysin
YY 0267-2025 Extracorporeal circulation blood circuit/fluid circuit for blood purification extracorporeal circulation system hemodialyzer, hemodialysis filter, hemofilter and hemoconcentrator
YY 0267-2016 Hemodialysis and related therapies―Extracorporeal blood circuit for blood purification devices
YY/T 0593-2022 Transcranial doppler ultrasound system
YY 0054-2003 Haemodialysis、haemodiafiltration and haemofiltration equipment
YY/T 1545-2017 Evaluation of connection between haemodialysis concentrate and haemodialysis equipment
YY/T 1245-2014 Automatic blood grouping analyzer
YY/T 0659-2008 Automated coagulation analyzer
YY/T 0653-2008 Hematology analyzer
YY/T 0659-2017 Blood coagulation analyzer
YY/T 1246-2014 Glycohemoglobin analyzer
YY/T 0456.1-2014 Reagents for hematology analyzer―Part 1:Rinse
YY/T 0456.3-2014 Reagents for hematology analyzer―Part 3:Diluent
YY 0054-2010 Haemodialysis equipment
YY/T 0658-2008 Semi-automated coagulation analyzer
YY 0054-2023 Haemodialysis equipment
YY 0593-2005 Ultrasound transcranial doppler system
YY 0053-2016 Hemodialysis and relavant therapics -Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
YY/T 1452-2016 Dry hematology analyzer(centrifuge method)
YY/T 0701-2008 Calibrator for hematology analyzer
YY/T 1784-2021 Blood gas analyzer
YY/T 0593-2015 Ultrasound transcranial Doppler system
YY 0053-2008 Cardiovascular implants and artificial organs—Haemodialysers haemodiafilters haemofilters and haemoconcentrators
YY/T 0653-2017 Hematology analyzer

未注明发布机构

CLSI H21-A5-2008 Approved Guidelines for the Collection, Transport, and Processing of Blood Specimens for Plasma-Based Coagulation Tests and Molecular Hemostasis Analysis (5th Edition)
FORD FLTM EU-CA 002-01-2001 METALLOGRAPHIC ANALYSIS OF NODULAR CAST IRON
AAMI 8637-2010-A1-2013- Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
JIS K 0701:1988 Glucose Analyzer
FORD FLTM EU-CA 002-1-2001 METALLOGRAPHIC ANALYSIS OF NODULAR CAST IRON
AAMI 8637-2010-A1-2013 Amendment No. 1 to Cardiovascular Implants and Extracorporeal Circulation Systems—Hemodialyzers, Hemodiafilters, Hemofilters, and Concentrators

Taiwan Provincial Standard of the People's Republic of China

CNS 14194-1998 Extracorporeal blood circuit for haemodialysers hasmofilters and haemoconcentrators
CNS 8333-1982 Haemocytometer
CNS 14193-1998 Haemodialysers,hasmofilters and haemoconcentrators

Professional Standard - Commodity Inspection

SN/T 1692.2-2006 Protocol of haemagglutination and haemagglutination-inhibition test for African horse sickness

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

JJF 2054-2023 Calibration Specification for Multifunctional Blood Gas Analyzers
JJF 1945-2021 Calibration Specification for Blood Coagulation Analyzers
JJF 1054-1996 Analysis Result Inorganic Composition in Serum
JJF 1841-2020 Calibration Specification for Glycohemoglobin Analyzers
JJF 1383-2012 Calibration Specification for Portable Blood Clucose Meters

Professional Standard - Hygiene

WS/T 779-2021 Reference intervals of blood cell analysis for children
WS 347-2011 Calibration Guide for Blood Cell Analysis
WS/T 347-2024 Guideline for the calibration of complete blood cell count
WS/T 347-2011 Guideline for the calibration of blood cell assays
WS/T 405-2012 Reference intervals for blood cell analysis

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
GB/T 23875-2009 Spray-dried animal blood cells for feedstuffs

National Health Commission of the People's Republic of China

WST 347:2011 Calibration Guide for Blood Cell Analysis

National Metrological Verification Regulations of the People's Republic of China

JJG 714-2012 Verification Regulation of Blood Cell Analyzers
JJG 553-1988 Blood Gas Acid -Base Analyser
JJG 714-1990 Verification Regulation of Blood Cell Analyzer

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

German Institute for Standardization

DIN 58932-3 E:2016-01 Haematology - Determination of the concentration of blood corpuscles in blood - Part 3: Reference method for the determination of the concentration of erythrozytes
DIN 58932-3:1994 Haematology; determination of the concentration of blood corpuscles in blood; determination of the concentration of erythrocytes; reference method
DIN-Fachbericht 153:2006 Von Willebrand Factor Analysis
DIN 58932-3:2017 Haematology - Determination of the concentration of blood corpuscles in blood - Part 3: Reference method for the determination of the concentration of erythrozytes; Text in German and English
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 12750:1969 Blood dilution pipettes for blood corpuscles counting
DIN EN 1283:1996 Hemodialyzers, hemodiafilters, hemofilters, hemoconcentrators and associated LJ blood tubing systems
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 8637-2:2024-09 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)
DIN 12845:1972 Westergren tubes for the erythrocyte sedimentation rate of red blood corpuscles
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
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 12750:1969-02 Blood dilution pipettes for blood corpuscles counting
DIN EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
DIN EN 1283:1996-06 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
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 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
DIN 58932-1:2023-08 Haematology - Determination of the concentration of blood corpuscles in blood - Part 1: Blood collection, sample preparation, influence quantities, interference factors; Text in German and English
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 8637 E:2013-06 Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodialysis filters, hemofilters and hemoconcentrators (draft)
DIN EN ISO 8638 E:2013-06 Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodiafilters and hemofilters for extracorporeal circulation (draft)
DIN 58932-1:2023 Haematology - Determination of the concentration of blood corpuscles in blood - Part 1: Blood collection, sample preparation, biological influence factors, interference factors; Text in German and English
DIN 58932-1 E:2010-01 Haematology - Determination of the concentration of blood corpuscles in blood - Part 1: Blood collection, sample preparation, biological influence factors, interference factors
DIN 58932-1:1996 Haematology - Determination of the concentration of blood corpuscles in blood - Part 1: Blood collection, sample preparation, biological influence factors, interference factors
DIN 58932-1:2012 Haematology - Determination of the concentration of blood corpuscles in blood - Part 1: Blood collection, sample preparation, biological influence factors, interference factors; Text in German and English
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
DIN EN ISO 8638:2014-03 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
DIN CEN/TS 16945:2016*DIN SPEC 13228:2016 Pre-analytical procedures for molecular analysis of in vitro diagnostic methods for metabolomics in urine, venous serum and plasma
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
DIN 58932-1 E:2010 Draft Document - Haematology - Determination of the concentration of blood corpuscles in blood - Part 1: Blood collection, sample preparation, biological influence factors, interference factors
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 58932-6:2021 Haematology - Determination of the concentration of blood corpuscles in blood - Part 6: Reference method for the determination of the concentration of CD4 positive lymphocytes; Text in German and English
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

Japanese Industrial Standards Committee (JISC)

JIS T 3236:2011 Styptic balloon
JIS T 4204:1974 Haemocytometer
JIS T 3236:2005 Styptic balloon
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 K 0602:1992 Methods for quantitative analysis of serum albumin

Korean Agency for Technology and Standards (KATS)

KS P 4204-1980 Haemocytometer
KS P 4204-2010(2016) Haemocytometer
KS P 4204-2010 Haemocytometer
KS P ISO 8637-1-2023 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P ISO 8637-2-2022 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
KS P ISO 8637-2023 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P 4907-2011 Haemodialysers, haemofilters and haemoconcentrators
KS P ISO 8637:2012 Cardiovascular implants and extracorporeal systems－Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P 4907-2013 Haemodialysers, haemofilters and haemoconcentrators
KS P ISO 8638-2022 Cardiovascular implants and extracorporeal systems －Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
KS J 4201-2023 Methods for quantitative analysis of serum albumin
KS J 4201-2008 Methods for quantitative analysis of serum albumin
KS P ISO 8638:2012 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 8637-2018 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P ISO 8637:2018 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS J 4201-2018 Methods for quantitative analysis of serum albumin
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 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 D ISO 8049:2003 Ferronickel shot－Sampling for analysis

CZ-CSN

CSN 70 5222-1965 Flask for white blood corpuscles
CSN ISO 8637:1994 Haemodialysers, haemofilters and haemoconcentrators
CSN ISO 8638:1994 Extracorporeal blood circuit for haemodialysers,haemofilters and haemoconcentrators
CSN 70 5224-1965 Pipette for white blood corpuscles
CSN 70 5223-1965 Pipette for red blood corpuscles

Military Standards (MIL-STD)

DOD A-A-50825-1981 CHAMBER, COUNTING, BLOOD CELLS, HEMACYTOMETER
DOD A-A-54504-1991 ANALYZER, BLOOD GAS
DOD A-A-53267 A-1990 ANALYZER, CENTRIFUGAL, HEMATOLOGY
DOD A-A-0053260-1987 GLOBULIN, IMMUNE FOR INJECTION
DOD A-A-53738-1988 MEMBRANE KIT, BLOOD GAS ANALYZER (PO2)
DOD A-A-53924-1989 RINSE SOLUTION, BLOOD GAS ANALYZER

Association Francaise de Normalisation

NF S93-302:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits.
NF EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
NF EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
NF EN ISO 23118:2021 In Vitro Molecular Diagnostic Assays - Preanalytical Process Specifications for Metabolome Analysis in Urine and Venous Blood (Serum and Plasma)
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 8637-2:2024 Extracorporeal systems for blood purification - Part 2 : extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
NF EN ISO 8637-2:2024 Extracorporeal systems for blood purification - Part 2 : extracorporeal blood and fluid circuits for 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 S93-302*NF EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
NF S93-303:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
NF C74-322:2002 Medical electrical equipment - Part 2-16 : particular requirement for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment.
NF S93-305-5*NF 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
NF 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
NF A13-602:1992 Ferronickel shot. Sampling for analysis.
NF A13-602*NF EN ISO 8049:2016 Ferronickel shot - Sampling for analysis

Standard Association of Australia （SAA）

AS K84:1941 Specification for haemacytometer counting chambers and haemacytometer
AS R3:1947 Specification for haemacytometer counting chambers and haemacytometer dilution pipettes

Indonesia Standards

SNI 16-6071-1999 Haemodialysers, haemofilters and haemoconcentrators
SNI ISO 8638:2012 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

International Organization for Standardization (ISO)

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/FDIS 8637-1:2023 Extracorporeal systems for blood purification — Part 1: 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/DIS 13959:1997 Water for Haemodialysis or Haemodiafiltration - Requirements
ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ISO/FDIS 8637-2:2023 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637-2:2024 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637:2010 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO/DIS 13958:1997 Concentrates for Haemodialysis or Haemodiafiltration
ISO 8637:2004 Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637:1989 Haemodialysers, haemofilters and haemoconcentrators
ISO 8638:2010 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ISO/DIS 8637-2 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8638:2004 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ISO 8638:1989 Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators

Danish Standards Foundation

DANSK DS/EN ISO 8637-1:2021 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
DANSK DS/ISO 8637-1:2024 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
DS/EN ISO 8637-1:2021 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
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)
DS/EN 1283:1997 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
DANSK DS/EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems – 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
DANSK DS/EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems – Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

Spanish Association for Standardization (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)
AENOR UNE 23054:1971 BLOOD TRANSFUSION. GAMMAGLOBULIN
UNE-EN 1283:1996 HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS.
UNE 111-325-1989 Hemodialysis, blood filters and blood hubs
AENOR UNE-EN 60601-2-16:1999 Electromedical equipment. Part 2-16: Particular requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration equipment.
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 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
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 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
UNE 111-350-1989 Hemodialysis, extracorporeal circulation with blood filters and blood hubs
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)
UNE-EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)

Bureau of Indian Standards

IS/ISO 8637-1-2017 Extracorporeal Systems for Blood Purification Part 1 Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators
IS/ISO 8637-2-2018 Extracorporeal Systems for Blood Purification Part 2 Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters
IS/ISO 8637-2010 Cardiovascular Implants and Extracorporeal Systems - Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators ( First Revision )
IS/ISO 8638-2010 Cardiovascular Implants and Extracorporeal Systems - Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters ( First Revision )

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 RD52-2004(2010) Dialysate for hemodialysis
ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ANSI/AAMI RD5-2003(2008) Hemodialysis systems
ANSI/AAMI/ISO 8638:2010(2015) Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
ANSI/AAMI/ISO 8637AMD 1:2012 Hemodialyzers, haemodiafilters, haemofilters and haemoconcentrators - Amendment 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports
ANSI/AAMI/ISO 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

SCC

AAMI/ISO 8637-1:2017 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
AAMI/ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
AAMI RD16:2007 Cardiovascular implants and artificial organs - Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
CAN 3-Z364.1.1-M84-1984 Hemodialyzers, hemofilters and hemoconcentrators
AAMI RD5:2003(R2008) Hemodialysis Systems
AAMI/ISO RD17:2007 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
AAMI RD61:2006 Concentrates for hemodialysis

Canadian Standards Association (CSA)

CSA ISO 8637-2:2021 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
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)
CAN/CSA-ISO 8637-1-2021 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017, IDT)
CAN/CSA Z364.1.1/Z364.1.2-1994(R2006) Haemodialysers, Haemofilters and Haemoconcentrators/ Extracorporeal Blood Circuit for Haemodialysers, Haemofilters and Haemoconcentrators
CSA Z8637-08-CAN/CSA-2008 Cardiovascular implants and artificial organs ?Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
CAN/CSA-Z364.1.1-1994(R2006) Haemodialysers, Haemofilters and Haemoconcentrators
CAN/CSA-Z364.1.1-1994(C2006) Hemodialyzers, hemofilters and hemoconcentrators
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 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-Z364.1.2-1994(R2006) Extracorporeal Blood Circuit for Haemodialysers, Haemofilters and Haemoconcentrators
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
CSA Z364.1.3-1998(R2014) Reuse of hemodialyzers
CAN/CSA-Z364.1.2-1994(C2006) Extracorporeal blood circuit for hemodialyzers, hemofilters and hemoconcentrators
CAN/CSA-Z8637-2008 Cardiovascular Implants and Artificial Organs - Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators

European Committee for Standardization (CEN)

EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
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)
EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers@ haemodiafilters and haemofilters
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)
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)

British Standards Institution (BSI)

23/30470631 DC BS ISO 8637-1. Extracorporeal systems for blood purification - Part 1. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
25/30513023 DC BS ISO 8637-1 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
BS 7297-1:1990 Haemodialysers and related equipment-Specification for haemodialysers, 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 8637:2014 Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
BS EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
25/30515248 DC BS EN ISO 8637-2 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
BS EN ISO 8637-2:2018 Extracorporeal systems for blood purification. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
BS 7297-2:1990 Haemodialysers and related equipment-Specification for extracorporeal circuits for use with haemodialysers, haemofilters and haemoconcentrators
BS EN ISO 8637-2:2024 Extracorporeal systems for blood purification - Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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 8637-1:2020 Extracorporeal systems for blood purification. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Swedish Institute for Standards

SS-EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
SS-EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
SS-EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
SS-EN 60601-2-16:1998 Medical electrical equipment - Part 2-16: Particular requirements for the safety 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

Standards Norway

NS-EN ISO 8637-1:2020 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
NS-EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
NS-EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
NS-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)

Ente Nazionale Italiano di Unificazione

UNI EN ISO 8637-2:2024 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
UNI CEN/TS 16945:2016 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma
UNI EN 1283:1998 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
UNI EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
UNI EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
UNI EN ISO 8049:2016 Ferronickel shot - Sampling for analysis

Magyar Szabványügyi Testület

MNOSZ 23102-1955 Ascorbic acid for analysis

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) )

US-AAMI

ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ANSI/AAMI RD16-2007 Cardiovascular implants and artificial organs-Hemodialyzers,hemodiafilters,hemofilters,and hemoconcentrators
ANSI/AAMI RD17-2007 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
ANSI/AAMI/ISO 8637:2010/A1:2013 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators - Amendment 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports

The Directorate General of Specifications and Metrology (DGSM)

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

GCC Standardization Organization

GSO ISO 8637:2016 Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
GSO ISO 8638:2016 Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ISO 8637:2017 Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
BH GSO ISO 8638:2017 Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

AT-ON

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

VN-TCVN

TCVN 7303-2-16-2007 Medical electrical equipment.Part 2-16: Particular requirements for the safety 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

CU-NC

NC 20-06-23-1987 Medical Sciences. Determination of Blood Erythrocyte Sedimentation Ratio. Testinq Method

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

International Electrotechnical Commission (IEC)

IEC 60601-2-16:2025 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
IEC 60601-2-16:2025 RLV Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Gosstandart of Russia

GOST R 52556-2006 Water for hemodialysis. Specifications
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

Comitato Elettrotecnico Italiano

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