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blood cell analysis

blood cell analysis, Total:338 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 , Chemical Measurement , Sanitation in general , Animal quarantine, veterinary and epidemic prevention , Livestock and poultry feed and additive .


Group Standards of the People's Republic of China

Professional Standard - Agriculture

Professional Standard - Medicine

国家药监局

Taiwan Provincial Standard of the People's Republic of China

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

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

Professional Standard - Hygiene

Professional Standard - Commodity Inspection

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

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 Metrological Verification Regulations of the People's Republic of China

National Health Commission of the People's Republic of China

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

卫生健康委员会

  • WS/T 779-2021 Reference intervals of blood cell analysis for children

Professional Standard - Aquaculture

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

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 12750:1969-02 Blood dilution pipettes for blood corpuscles counting
  • DIN 12845:1972 Westergren tubes for the erythrocyte sedimentation rate of red blood corpuscles
  • DIN EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
  • DIN EN ISO 8637-2:2024 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)
  • DIN EN ISO 8637-2 E:2016-05 Extracorporeal systems for blood purification Part 2: Extracorporeal blood circuits for hemodialyzers, hemodiafilters and hemofilters (draft)
  • DIN EN ISO 8637-2 E:2023-01 Extracorporeal systems for blood purification Part 2: Extracorporeal blood circuits for hemodialyzers, hemodiafilters and hemofilters (draft)
  • DIN EN ISO 8637 E:2013-06 Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodialysis filters, hemofilters and hemoconcentrators (draft)
  • DIN EN ISO 8637-2:2023-01 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/DIS 8637-2:2022); German and English version prEN ISO 8637-2:2022 / Note: Date...
  • DIN 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 8638 E:2013-06 Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodiafilters and hemofilters for extracorporeal circulation (draft)
  • 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 58932-1:2012 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 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 58932-1:1996 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 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 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

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
  • JIS K 0602:2000 Proteins -- Serum albumin -- Methods for quantitative analysis
  • 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

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 4907-2011 Haemodialysers, haemofilters and haemoconcentrators
  • KS P ISO 8637-2023 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • KS P 4907-2013 Haemodialysers, haemofilters and haemoconcentrators
  • KS P ISO 8637:2012 Cardiovascular implants and extracorporeal systems-Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • KS P ISO 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 P ISO 8638:2012 Cardiovascular implants and extracorporeal systems -Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • KS J 4201-2008 Methods for quantitative analysis of serum albumin
  • 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 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 D ISO 8049:2003 Ferronickel shot-Sampling for analysis

CZ-CSN

Military Standards (MIL-STD)

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 8637-2:2018 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 A13-602:1992 Ferronickel shot. Sampling for analysis.
  • NF A13-602*NF EN ISO 8049:2016 Ferronickel shot - Sampling for analysis
  • 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 60601-2-16:2015 Medical electrical equipment - Part 2-16 : particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
  • NF 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

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/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 8637-2:2024 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 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 8638:2004 Cardiovascular implants and artificial organs - 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 8638:1989 Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators

Danish Standards Foundation

  • DS/EN ISO 8637-1:2021 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • DS/EN 1283:1997 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
  • 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

BSI

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

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
  • 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
  • ANSI/NCCLS H11-A 2-1992 Percutaneous Collection of Arterial Blood for Laboratory Analysis

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-EN 1283:1996 HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS.
  • UNE 111-325-1989 Hemodialysis, blood filters and blood hubs
  • 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)
  • UNE 111-350-1989 Hemodialysis, extracorporeal circulation with blood filters and blood hubs
  • 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 111301:1990 REQUIREMENTS OF WATER USED IN HEMODIALYSIS
  • 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.)

SCC

  • DANSK DS/EN ISO 8637-1:2021 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • 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
  • ISO/DIS 13959:1997 Water for Haemodialysis or Haemodiafiltration - Requirements
  • 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)
  • 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)
  • CAN/CSA Z364.1.1/Z364.1.2-1994(R2006) Haemodialysers, Haemofilters and Haemoconcentrators/ Extracorporeal Blood Circuit for Haemodialysers, Haemofilters and Haemoconcentrators
  • NS-EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
  • CAN/CSA-ISO 8637-1-2021 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017, IDT)
  • AENOR UNE 23054:1971 BLOOD TRANSFUSION. GAMMAGLOBULIN
  • NS-EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
  • BS 7297-1:1990 Haemodialysers and related equipment-Specification for haemodialysers, haemofilters and haemoconcentrators
  • AAMI RD16:2007 Cardiovascular implants and artificial organs - Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
  • 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
  • ISO/DIS 13958:1997 Concentrates for Haemodialysis or Haemodiafiltration
  • DANSK DS/EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems – Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • CAN/CSA-Z364.1.1-1994(C2006) Hemodialyzers, hemofilters and hemoconcentrators
  • CAN 3-Z364.1.1-M84-1984 Hemodialyzers, hemofilters and hemoconcentrators
  • CAN/CSA-Z364.1.1-1994(R2006) 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
  • AAMI RD5:2003(R2008) Hemodialysis Systems
  • AAMI/ISO RD17:2007 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
  • DANSK DS/EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems – Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • 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
  • 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
  • AENOR UNE-EN 60601-2-16:1999 Electromedical equipment. Part 2-16: Particular requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration equipment.
  • CAN/CSA-Z364.1.2-1994(R2006) Extracorporeal Blood Circuit for Haemodialysers, Haemofilters and Haemoconcentrators
  • AENOR UNE-EN 60601-2-16 CORR:2000 Electromedical equipment - Part 2-16: Particular requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration equipment.
  • AAMI RD61:2006 Concentrates for hemodialysis
  • AENOR UNE-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
  • NS-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
  • BS 7297-2:1990 Haemodialysers and related equipment-Specification for extracorporeal circuits for use with haemodialysers, haemofilters and haemoconcentrators
  • CAN/CSA-Z364.1.2-1994(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
  • 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
  • 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
  • CAN 3-Z364.1.2-M84-1984 Extracorporeal circuits for hemodialyzers, hemofilters and hemoconcentrators
  • 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 8637:2014 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
  • AAMI RD52:2004 Dialysate for Hemodialysis (Includes A1:2007 and A2:2007)
  • AAMI RD47:2020 Reprocessing of hemodialyzers
  • 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/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
  • 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
  • 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-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

Canadian Standards Association (CSA)

  • CSA ISO 8637-2:2021 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • 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)
  • 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 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-Z8637-2008 Cardiovascular Implants and Artificial Organs - Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators
  • CSA C22.2 No.60601-2-16-01-2001 Medical Electrical Equipment - Part 2-16: Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment Second Edition; IEC 60601-2-16:1998
  • CSA 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 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]

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)

KR-KS

  • KS P ISO 8637-2-2022 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • KS P ISO 8637-2018 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • 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 60601-2-16-2022 Medical electrical equipment — Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

British Standards Institution (BSI)

  • 23/30470631 DC BS ISO 8637-1. Extracorporeal systems for blood purification - Part 1. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • 16/30331650 DC BS EN ISO 8637-1. Extracorporeal systems for blood purification. Part 1. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • BS EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • BS EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • BS EN ISO 8637-2:2018 Extracorporeal systems for blood purification. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • 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

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

HU-MSZT

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) )

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
  • GSO ISO 8638:2016 Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • OS GSO ISO 8638:2016 Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • BH GSO ISO 8638:2017 Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • 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
  • 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

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

AT-ON

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

IN-BIS

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

VN-TCVN

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

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

RU-GOST R

  • 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
  • GOST R ISO 8637-1999 Haemodialysers, haemofilters and haemoconcentrators. Technical requirements and test methods
  • GOST 25382-1982 Domestic animals. Methods of laboratory diagnostics of leucosus

(U.S.) Ford Automotive Standards

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

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

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