Hematology Analyzer

Hematology Analyzer, Total:135 items.

The international standard classification for "Hematology Analyzer" includes: Laboratory medicine , Radiographic equipment , Surgical instruments and materials , Transfusion, infusion and injection equipment .

The Chinese standard classification for "Hematology Analyzer" includes: Medical laboratory equipment , Medical ultrasound, laser, high-frequency instrument and equipment , Extracorporeal circulation, artificial organ and prosthesis device , Chemical Measurement .

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 0659-2017 Blood coagulation analyzer
YY/T 0658-2008 Semi-automated coagulation analyzer
YY/T 1246-2014 Glycohemoglobin analyzer
YY/T 0659-2008 Automated coagulation analyzer
YY/T 1460-2016 Blood rheometer
YY/T 0456.1-2014 Reagents for hematology analyzer―Part 1:Rinse
YY/T 0456.3-2003 Regents for hematology analyzer use—Part 3:Diluent
YY/T 0659-2017/XG1-2022 Blood coagulation analyzer, includes Amendment 1
YY/T 1452-2016 Dry hematology analyzer(centrifuge method)
YY 0054-2003 Haemodialysis、haemodiafiltration and haemofiltration equipment
YY/T 0653-2017 Hematology analyzer
YY/T 0701-2008 Calibrator for hematology analyzer
YY/T 0456.2-2003 Regents for hematology analyzer use - Part 2: Hemolysin
YY/T 0456.3-2014 Reagents for hematology analyzer―Part 3:Diluent
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/XG1-2022 Hematology analyzer|| inlucdes Amendment 1
YY/T 1245-2014 Automatic blood grouping analyzer
YY 0593-2005 Ultrasound transcranial doppler system
YY/T 0456.1-2003 Regents for hematology analyzer use - Part 1: Rinse
YY/T 0702-2008 Control material for hematology analyzer
YY 0053-2016 Hemodialysis and relavant therapics -Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
YY/T 0653-2008 Hematology analyzer
YY/T 1784-2021 Blood gas analyzer
YY/T 0593-2022 Transcranial doppler ultrasound system

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

JJF 1541-2015 Calibration Specification for Hemodialysis Equipment Tester
JJF 1937-2021 Calibration Specification for Automated Blood Bacteria Culture Analyzers
JJF 2054-2023 Calibration Specification for Multifunctional Blood Gas Analyzers
JJF 1945-2021 Calibration Specification for Blood Coagulation Analyzers
JJF 1383-2012 Calibration Specification for Portable Blood Clucose Meters
JJF 1841-2020 Calibration Specification for Glycohemoglobin Analyzers

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

Group Standards of the People's Republic of China

T/GDMDMA 0043-2025 Blood Gas/Electrolyte and Metabolite Analyzer

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

Taiwan Provincial Standard of the People's Republic of China

CNS 14193-1998 Haemodialysers,hasmofilters and haemoconcentrators

Japanese Industrial Standards Committee (JISC)

JIS K 0701:1988 Glucose Analyzer
JIS T 3250:2022 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
JIS T 3250:2011 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
JIS T 3250:2005 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
JIS T 3250:2013 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

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

German Institute for Standardization

DIN-Fachbericht 153:2006 Von Willebrand Factor Analysis
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 1283:1996 Hemodialyzers, hemodiafilters, hemofilters, hemoconcentrators and associated LJ blood tubing systems
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 8637-2:2024-09 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)
DIN EN ISO 8637-2:2024 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)
DIN EN ISO 8637-1 E:2016-05 Extracorporeal systems for blood purification Part 1: Hemodialyzers, hemodialysis filters, hemofilters and hemoconcentrators (draft)
DIN EN 1283:1996-06 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits

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 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 8637-2:2024 Extracorporeal systems for blood purification - Part 2 : extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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 S93-302*NF EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Czech Standards Institute (UNMZ)

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

Danish Standards Foundation

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/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
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
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)

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

International Organization for Standardization (ISO)

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

Association for the Advancement of Medical Instrumentation

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
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

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)
UNE 111-325-1989 Hemodialysis, blood filters and blood hubs
UNE-EN 1283:1996 HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS.

Korean Agency for Technology and Standards (KATS)

KS P ISO 8637-1-2023 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P ISO 8637-2-2022 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
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 8637-2023 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 8637-1:2017 Extracorporeal systems for blood purification— Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ANSI/AAMI/ISO 8637-2:2018 Extracorporeal systems for blood purification— Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

Canadian Standards Association (CSA)

CAN/CSA Z364.1.1/Z364.1.2-1994(R2006) Haemodialysers, Haemofilters and Haemoconcentrators/ Extracorporeal Blood Circuit for Haemodialysers, Haemofilters and Haemoconcentrators
CSA ISO 8637-2:2021 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
CAN/CSA-Z364.1.1-1994(R2006) Haemodialysers, Haemofilters and Haemoconcentrators
CAN/CSA-Z364.1.1-1994(C2006) Hemodialyzers, hemofilters and hemoconcentrators
CSA Z8637-08-CAN/CSA-2008 Cardiovascular implants and artificial organs ?Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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-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-Z364.1.2-1994(R2006) Extracorporeal Blood Circuit for Haemodialysers, 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 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers@ haemodiafilters and haemofilters
EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)

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 EN 1283:1998 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits

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
BS EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems. 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

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

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

Canadian General Standards Board （CGSB)

CAN 3-Z364.1.1-M84-1984 Hemodialyzers, hemofilters and hemoconcentrators

Lithuanian Standards Office

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

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ISO 8637:2017 Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

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

Clinical and Laboratory Standards Institute

CLSI H26-A2-2010 Verification, Validation and Quality Assurance of Automated Hematology Analyzers

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