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Hematology Analyzer

Hematology Analyzer, Total:498 items.

In the international standard classification, Hematology Analyzer involves: Laboratory medicine, Medical equipment, Precision mechanics, Protective equipment, Medical sciences and health care facilities in general, Analytical chemistry, Pharmaceutics, Vocabularies, First aid, HEALTH CARE TECHNOLOGY, Veterinary medicine, Meat, meat products and other animal produce, Sacks. Bags, Quality, Hospital equipment, Products of the chemical industry, Jewellery, Protection against fire.


Professional Standard - Medicine, Hematology Analyzer

国家药监局, Hematology Analyzer

  • YY/T 1784-2021 blood gas analyzer
  • YY/T 0701-2021 Calibrators for blood analyzers
  • YY 0054-2023 hemodialysis equipment
  • YY/T 1830-2022 Electric pneumatic hemostasis instrument
  • YY/T 0663.1-2021 Cardiovascular Implants Endovascular Devices Part 1: Endovascular Prostheses
  • YY/T 1631.1-2018 Determination of compatibility between blood transfusion sets and blood components Part 1: Assessment of blood component residues
  • YY/T 1631.2-2020 Determination of compatibility of blood transfusion sets and blood components Part 2: Assessment of blood component damage
  • YY/T 1730-2020 Disposable hemodialysis catheter
  • YY/T 0793.4-2022 Preparation and quality management of fluids for hemodialysis and related treatments Part 4: Quality of dialysate fluids for hemodialysis and related treatments
  • YY/T 0793.1-2022 Preparation and quality management of fluids for hemodialysis and related treatments Part 1: Water treatment equipment for hemodialysis and related treatments
  • YY 0465-2019 Single use membrane plasmaseparator

Indonesia Standards, Hematology Analyzer

National Metrological Technical Specifications of the People's Republic of China, Hematology Analyzer

  • JJF 1945-2021 Calibration Specification for Blood Coagulation Analyzers
  • JJF 1383-2012 Calibration Specification for Portable Blood Glucose Meters
  • JJF 2054-2023 Calibration Specification for Multifunctional Blood Gas Analyzers
  • JJF 1841-2020 Calibration Specification for Glycohemoglobin Analyzers
  • JJF 1541-2015 Calibration Specification for Hemodialysis Equipment Tester
  • JJF 1353-2012 Calibration Specification for Hemodialysis Equipment
  • JJF 1054-1996 Evaluation Specification for Analysis Result of Inorganic Composition in Serum
  • JJF 1542-2015 Calibration Specification for SpO<下标2> Simulator

National Metrological Verification Regulations of the People's Republic of China, Hematology Analyzer

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

German Institute for Standardization, Hematology Analyzer

  • 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 ISO 8637-2:2018-12 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018); German version EN ISO 8637-2:2018 / Note: To be replaced by DIN EN ISO 8637-2 (2023-01).
  • DIN EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
  • DIN EN ISO 8637-2:2023-01 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/DIS 8637-2:2022); German and English version prEN ISO 8637-2:2022 / Note: Date...
  • DIN EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010); German version EN ISO 8638:2014
  • DIN EN ISO 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 58905-1:2016-12 Haemostaseology - Blood collection - Part 1: Preparation of plasma from citrated venous blood for coagulation testing; Text in German and English
  • DIN 58934-1:1997 Haematology - Control material for the CBC - Part 1: Control bloods
  • DIN EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1:2013-04-01); German version EN ISO 8637:2014
  • DIN EN ISO 25539-2:2021-01 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020); German version EN ISO 25539-2:2020
  • DIN EN ISO 25539-1:2018-05 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017); German version EN ISO 25539-1:2017 / Note: DIN EN ISO 25539-1 (2017-09) and DIN EN ISO 25539-1 (2009-08) remain valid alongside this standard until 202...
  • DIN 58910-4:2000-03 Haemostaseology - Determination of thromboplastin (prothrombin) time - Part 4: Reference measurement procedure for the determination in capillary blood
  • DIN 58932-3:1994 Haematology; determination of the concentration of blood corpuscles in blood; determination of the concentration of erythrocytes; reference method
  • DIN EN 60601-2-16:1999 Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:1998); German version EN 60601-2-16:1998
  • DIN 58932-5:2007-10 Haematology - Determination of the concentration of blood corpuscles in blood - Part 5: Reference method for the determination of the concentration of thrombocytes; Text in German and English
  • DIN 58910-1:2016-02 Haemostaseology - Determination of thromboplastin (prothrombin) time - Part 1: Reference measurement procedure for the determination in plasma from citrated venous blood; Text in German and English
  • DIN 58910-3:2000-03 Haemostaseology - Determination of the thromboplastin (prothrombin) time - Part 3: Reference measurement procedure for the determination in citrated capillary blood
  • DIN 58932-5:2007 Haematology - Determination of the concentration of blood corpuscles in blood - Part 5: Reference method for the determination of the concentration of thrombocytes; Text in German and English
  • 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 58939-1:2000-03 Haemostaseology - Reference plasma - Part 1: Requirements, preparation
  • DIN EN ISO 23500-3:2019-11 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019); German version EN ISO 23500-3:2019 / Note: To be replaced by DIN EN ISO 23500-3 (2022-12).
  • DIN EN ISO 23500-3:2022-12 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO/DIS 23500-3:2022); German and English version prEN ISO 23500-3:2022 / Note: Date of issue 2022-11-18*Inten...
  • DIN 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 58914-1:2000-03 Haemostaseology - Determination of thrombin time - Part 1: Reference measurement procedure for the determination in plasma from citrated venous blood
  • DIN 58939-1:2000 Haemostaseology - Reference plasma - Part 1: Requirements, preparation
  • DIN EN ISO 1135-3:2017-05 Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016); German version EN ISO 1135-3:2017
  • DIN 58934-1:1997-12 Haematology - Control material for the CBC - Part 1: Control bloods
  • 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 23500-5:2022-12 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/DIS 23500-5:2022); German and English version prEN ISO 23500-5:2022 / Note: Date of is...
  • DIN EN ISO 23500-5:2019-11 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019); German version EN ISO 23500-5:2019 / Note: To be replaced by DIN EN ISO...
  • DIN 58932-4:2003 Haematology - Determination of the concentration of blood corpuscles in blood - Part 4: Reference procedure for the determination of the concentration of leucocytes
  • DIN EN ISO 23500-4:2019-11 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019); German version EN ISO 23500-4:2019 / Note: To be replaced by DIN EN ISO 23500-4 (202...
  • DIN EN ISO 23500-4:2022-12 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO/DIS 23500-4:2022); German and English version prEN ISO 23500-4:2022 / Note: Date of issue 2022-11-1...
  • DIN 58910-2:2000-03 Haemostaseology - Determination of thromboplastin (prothrombin) time - Part 2: Reference measurement procedure for the determination in citrated venous blood
  • DIN 58914-1:2000 Haemostaseology - Determination of thrombin time - Part 1: Reference measurement procedure for the determination in plasma from citrated venous blood
  • DIN EN ISO 1135-4:2012 Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2012); German version EN ISO 1135-4:2012
  • 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 58932-3:2017-01 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 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 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019)
  • DIN 58910-1:2000 Haemostaseology - Determination of thromboplastin (prothrombin) time - Part 1: Reference measurement procedure for the determination in plasma from citrated venous blood
  • DIN 58910-1:2016 Haemostaseology - Determination of thromboplastin (prothrombin) time - Part 1: Reference measurement procedure for the determination in plasma from citrated venous blood; Text in German and English
  • DIN EN ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
  • DIN 12846:1978 Laboratory glassware; hematocrit capillaries
  • DIN EN ISO 13959:2016 Water for haemodialysis and related therapies (ISO 13959:2014)
  • DIN 58932-2:1998 Haematology - Determination of the concentration of blood corpuscles in blood - Part 2: Characteristic quantities for erythrocytes (erythrocyte indices)
  • DIN 58932-2:1998-06 Haematology - Determination of the concentration of blood corpuscles in blood - Part 2: Characteristic quantities for erythrocytes (erythrocyte indices)
  • DIN 58932-3:2023-07 Haematology - Determination of the concentration of blood corpuscles in blood - Part 3: Reference method for the determination of the concentration of erythrocytes; Text in German and English / Note: Date of issue 2023-06-02*Intended as replacement for...
  • DIN 58932-4:2003-07 Haematology - Determination of the concentration of blood corpuscles in blood - Part 4: Reference procedure for the determination of the concentration of leucocytes
  • DIN EN ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019)
  • DIN EN ISO 23500-2:2019-11 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2019); German version EN ISO 23500-2:2019 / Note: To be replaced ...

Association Francaise de Normalisation, Hematology Analyzer

  • NF S93-302:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits.
  • NF EN ISO 8637-1:2020 Systèmes extracorporels pour la purification du sang - Partie 1 : hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs
  • NF EN ISO 8637-2:2018 Systèmes extracorporels pour la purification du sang - Partie 2 : circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres
  • 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 EN ISO 23118:2021 Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour l'analyse du métabolome dans l'urine et le sang veineux (sérum et plasma)
  • NF S90-304:1989 MEDICO-SURGICAL EQUIPMENT. HAEMODIALYSIS EQUIPMENT. OPERATING DATA.
  • NF C74-322:2002 Medical electrical equipment - Part 2-16 : particular requirement for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment.
  • NF C74-322:1986 Medical electrical equipment. Part 2 : particular requirement for safety of haemodialysis equipment.
  • NF S94-203-2:2013 Cardiovascular implants - Endovascular devices - Part 2: vascular stents
  • 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
  • NF EN IEC 60601-2-16:2019 Appareils électromédicaux - Partie 2-16 : exigences particulières pour la sécurité de base et les performances essentielles des appareils d'hémodialyse, d'hémodiafiltration et d'hémofiltration
  • NF S94-203-1:2008 Cardiovascular implants - Endovascular devices - Part 1 : endovascular prostheses.
  • NF S94-203-1*NF EN ISO 25539-1:2018 Cardiovascular implants - Endovascular devices - Part 1 : endovascular prostheses
  • NF EN ISO 25539-1:2018 Implants cardiovasculaires - Dispositifs endovasculaires - Partie 1 : prothèses endovasculaires
  • NF U47-101:2007 Méthodes d'analyse en santé animale - Isolement et identification de tout sérovar ou de sérovar(s) spécifié(s) de salmonelles chez les oiseaux
  • NF U47-023:2001 Animal health analysis method - Detection of antibodies against viral haemorrhagic septicemia of Salmonidae by virus neutralisation test.
  • NF EN ISO 23500-4:2019 Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes - Partie 4 : concentrés pour hémodialyse et thérapies apparentées
  • NF U47-210:2016 Animal health analysis methods - Isolation of hemagglutinating avian myxoviruses by ovoculture and detection of their hemagglutinating activity
  • NF S93-305-3*NF EN ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3 : water for haemodialysis and related therapies
  • NF EN ISO 23500-3:2019 Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes - Partie 3 : eau pour hémodialyse et thérapies apparentées
  • NF S93-305-5*NF EN ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5 : quality of dialysis fluid for haemodialysis and related therapies
  • NF EN ISO 23500-5:2019 Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes - Partie 5 : qualité des liquides de dialyse pour hémodialyse et thérapies apparentées
  • NF EN ISO 3826-3:2008 Poches en plastique souple pour le sang et les composants du sang - Partie 3 : systèmes de poches pour le sang avec accessoires intégrés
  • NF S93-305-4*NF EN ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4 : concentrates for haemodialysis and related therapies
  • NF EN ISO 25539-2:2020 Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2 : endoprothèses vasculaires
  • NF S93-301/IN1:2009 Concentrates for haemodialysis and related therapies.
  • NF S93-301:2009 Concentrates for haemodialysis and related therapies.
  • NF EN ISO 20186-3:2019 Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour le sang total veineux - Partie 3 : ADN libre circulant extrait du plasma
  • NF EN ISO 3826-4:2015 Poches en plastique souple pour le sang et les composants du sang - Partie 4 : systèmes de poches d'aphérèse pour le sang avec accessoires intégrés
  • NF U47-102:2008 Méthodes d'analyse en santé animale - Isolement et identification de tout sérovar ou de sérovar(s) spécifié(s) de salmonelles chez les mammifères
  • NF S93-253-4:2005 Transfusion equipment for medical use - Part 4 : transfusion sets for single use.
  • NF S93-253-4:2012 Transfusion equipment for medical use - Part 4 : transfusion sets for single use.
  • NF S93-230-3*NF EN ISO 3826-3:2008 Plastics collapsible containers for human blood and blood components - Part 3 : blood bag systems with integrated features
  • NF EN ISO 3826-1:2019 Poches en plastique souple pour le sang et les composants du sang - Partie 1 : poches conventionnelles
  • NF S93-315:2008 Fluids for hemodialysis - Requirements and user recommendations
  • NF S93-305-2*NF EN ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2 : water treatment equipment for haemodialysis applications and related therapies
  • NF EN ISO 23500-2:2019 Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes - Partie 2 : équipement de traitement de l'eau pour des applications en hémodialyse et aux thérapies apparentées

Japanese Industrial Standards Committee (JISC), Hematology Analyzer

  • JIS T 3250:2022 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • JIS T 3250:2005 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • JIS T 3250:2011 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • JIS T 3250:2013 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • JIS T 1305:1985 Direct blood-pressure monitors
  • JIS K 0602:1992 Methods for quantitative analysis of serum albumin
  • 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
  • JIS K 0602:2000 Proteins -- Serum albumin -- Methods for quantitative analysis
  • JIS T 0601-2-16:2008 Medical electrical equipment -- Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemodiafiltration equipment
  • JIS T 3217:2011 Plastic collapsible containers for human blood and blood components
  • JIS T 3217:2016 Plastic collapsible containers for human blood and blood components
  • JIS T 3217:2005 Plastic collapsible containers for human blood and blood components
  • JIS T 0601-2-16:2014 Medical electrical equipment -- Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

CZ-CSN, Hematology Analyzer

Danish Standards Foundation, Hematology Analyzer

  • 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
  • DS/EN ISO 25539-2:2013 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
  • DS/EN ISO 25539-1/AC:2011 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
  • DS/EN ISO 25539-1:2009 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses

International Organization for Standardization (ISO), Hematology Analyzer

  • ISO/DIS 8637-1 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO/CD 8637-1 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO 8637-1:2017 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO/FDIS 8637-2:2023 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO 8637:1989 Haemodialysers, haemofilters and haemoconcentrators
  • ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • ISO 8637:2004 Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO 8637:2010 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • ISO 8638:1989 Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators
  • ISO 8638:2004 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • 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 8637:2010/Amd 1:2013 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators - Amendment 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports
  • ISO 25539-2:2008 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
  • ISO 25539-2:2012 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
  • ISO 25539-2:2020 Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
  • ISO 25539-1:2003 Cardiovascular implants — Endovascular devicesPart 1:Endovascular prostheses
  • ISO 25539-1:2017 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
  • ISO 1135-3:1986 Transfusion equipment for medical use; Part 3 : Blood-taking set
  • ISO 13959:2009 Water for haemodialysis and related therapies
  • ISO 13959:2002 Water for haemodialysis and related therapies
  • ISO 13959:2014 Water for haemodialysis and related therapies
  • ISO/DIS 23500-3 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
  • ISO 3826:1993 Plastics collapsible containers for human blood and blood components
  • ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
  • ISO 1135-3:2016 Transfusion equipment for medical use - Part 3: Blood-taking sets for single use
  • ISO/DIS 23500-5 Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
  • ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
  • ISO/FDIS 23500-5:2011 Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
  • ISO/DIS 23500-4 Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
  • ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies
  • ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
  • ISO/FDIS 23500-4:2011 Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
  • ISO 13958:2002 Concentrates for haemodialysis and related therapies
  • ISO 13958:2009 Concentrates for haemodialysis and related therapies
  • ISO 13958:2014 Concentrates for haemodialysis and related therapies
  • ISO 25539-1:2003/Amd 1:2005 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses; Amendment 1: Test methods
  • ISO 3826-3:2006 Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features
  • ISO 1135-4:2004 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
  • ISO 1135-4:2010 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
  • ISO 1135-4:2012 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
  • ISO 2553:2019 Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices
  • ISO 25539-4:2021 Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices
  • ISO/DIS 23500-2 Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies
  • ISO 8637-3:2018 Extracorporeal systems for blood purification - Part 3: Plasmafilters
  • ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies

ES-UNE, Hematology Analyzer

  • UNE-EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
  • UNE-EN ISO 8637-2:2019 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
  • UNE-EN ISO 25539-2:2021 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
  • 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.)
  • UNE-EN ISO 25539-1:2017 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017) (Endorsed by Asociación Española de Normalización in June of 2017.)
  • UNE-EN ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019)
  • ISO/FDIS 23500-3:2023 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
  • UNE-EN ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
  • UNE-EN ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019)
  • UNE-EN ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2019)

未注明发布机构, Hematology Analyzer

European Committee for Standardization (CEN), Hematology Analyzer

  • 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)
  • 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 1283:1996 Haemodialysers, Haemodiafilters, Haemofilters, Haemoconcentrators and Their Extracorporeal Circuits
  • EN 865:1997 Pulse Oximeters - Particular Requirements
  • EN ISO 25539-2:2020 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
  • EN ISO 25539-2:2012 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
  • EN ISO 25539-2:2009 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
  • EN ISO 25539-1:2017 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
  • EN ISO 25539-1:2009 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (Incorporating corrigendum February 2011)
  • EN ISO 1135-4:2012 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
  • EN ISO 25539-2:2008 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents [Superseded: CEN EN 14299]
  • EN ISO 3826-1:2003 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers ISO 3826-1:2003
  • EN ISO 3826-3:2007 Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated
  • EN ISO 1135-4:2011 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
  • EN ISO 1135-4:2010 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
  • prEN ISO 23500-5 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/DIS 23500-5:2022)
  • prEN ISO 23500-3 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO/DIS 23500-3:2022)

ES-AENOR, Hematology Analyzer

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Hematology Analyzer

  • 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 18469-2001 Standards for whole blood and blood components quality
  • GB 18469-2012 Quality requirements for whole blood and blood components
  • GB 14232.1-2004 Plastics collapsible containers for human blood and blood components-Part 1:Conventional containers
  • GB/T 14232.1-2020 Plastics collapsible containers for human blood and blood components—Part 1:Conventional containers
  • GB 14232.3-2011 Plastics collapsible containers for human blood and blood components. Part 3:Blood bag systems with integrated features

Korean Agency for Technology and Standards (KATS), Hematology Analyzer

  • KS P 4907-2011 Haemodialysers, 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 8638:2012 Cardiovascular implants and extracorporeal systems -Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • KS P ISO 8637:2018 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • KS E 4920-1988(2009) Digital oxygen detector
  • KS P ISO 8638-2012(2017) 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 9919-2007(2012) Pulse oximeters for medical use-Requirements
  • KS J 4201-2008 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 P ISO 25539-2:2009 Cardiovascular implants-Endovascular devices-Part 2:Vascular stents
  • KS P ISO 25539-2:2020 Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
  • KS J 4201-2018 Methods for quantitative analysis of serum albumin
  • KS P ISO 25539-1:2010 Cardiovascular implants-Endovascular devices-Part 1:Endovascular prostheses
  • KS P ISO 25539-1:2017 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
  • KS P ISO 13959:2009 Water for haemodialysis and related therapies
  • KS P ISO 13959-2009(2019) Water for haemodialysis and related therapies
  • KS P ISO 23500-3:2021 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
  • KS P ISO 1135-4:2010 Transfusion equipment for medical use-Part 4:Transfusion sets for single use
  • KS P ISO 1135-3:2020 Transfusion equipment for medical use ―Part 3: Blood-taking sets for single use
  • KS P ISO 1135-4:2014 Transfusion equipment for medical use — Part 4: Transfusion sets for single use
  • KS P ISO 23500-4:2021 Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
  • KS P ISO 13958:2009 Concentrates for haemodialysis and related therapies
  • KS P ISO 13958-2009(2019) Concentrates for haemodialysis and related therapies
  • KS P ISO 3826-3:2019 Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features

Taiwan Provincial Standard of the People's Republic of China, Hematology Analyzer

  • CNS 14193-1998 Haemodialysers,hasmofilters and haemoconcentrators
  • CNS 14194-1998 Extracorporeal blood circuit for haemodialysers hasmofilters and haemoconcentrators

KR-KS, Hematology Analyzer

  • 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 P ISO 25539-2-2020 Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
  • 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
  • KS P ISO 25539-1-2017 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
  • KS P ISO 25539-1-2022 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
  • KS P ISO 23500-3-2021 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
  • KS P ISO 1135-3-2020 Transfusion equipment for medical use ―Part 3: Blood-taking sets for single use
  • KS P ISO 23500-5-2022 Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
  • KS P ISO 23500-4-2021 Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
  • KS P ISO 11663-2017 Quality of dialysis fluid for haemodialysis and related therapies
  • KS P ISO 8637-3-2022 Extracorporeal systems for blood purification Part 3: Plasmafilters
  • KS P ISO 3826-3-2019 Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features

CEN - European Committee for Standardization, Hematology Analyzer

  • EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers@ haemodiafilters and haemofilters
  • EN ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
  • EN ISO 23500-5:2019 Preparation and quality management of f luids for haemodialysis and related therapies - Part 5: Quality of dialysis f luid for haemodialysis and related therapies
  • EN ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
  • EN ISO 1135-4:2004 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
  • EN ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies

British Standards Institution (BSI), Hematology Analyzer

  • 23/30470631 DC BS 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
  • 16/30331650 DC BS EN ISO 8637-1. Extracorporeal systems for blood purification. Part 1. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • BS EN ISO 8637-1:2020 Extracorporeal systems for blood purification. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • BS EN ISO 8637-2:2018 Tracked Changes. Extracorporeal systems for blood purification. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • 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 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
  • 12/30254337 DC BS ISO 8637 AMD1. Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • BS EN 60601-2-16:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
  • BS EN IEC 60601-2-16:2019 Tracked Changes. Medical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
  • BS ISO 13959:2014 Water for haemodialysis and related therapies
  • BS ISO 13959:2009 Water for haemodialysis and related therapies
  • 19/30385889 DC BS EN ISO 25539-2. Cardiovascular implants. Endovascular devices. Part 2. Vascular stents
  • 21/30433073 DC BS EN IEC 60601-2-16. Medical electrical equipment. Part 2-16. Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
  • BS EN ISO 3826-3:2007 Plastics collapsible containers for human blood and blood components - Blood bag systems with integrated features
  • BS EN ISO 3826-3:2006 Plastics collapsible containers for human blood and blood components. Blood bag systems with integrated features
  • BS ISO 3826-3:2006 Plastics collapsible containers for human blood and blood components - Blood bag systems with integrated features
  • BS EN 13867:2002+A1:2009 Concentrates for haemodialysis and related therapies
  • BS EN 13867:2002 Concentrates for haemodialysis and related therapies
  • BS EN ISO 13958:2015 Concentrates for haemodialysis and related therapies
  • BS ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies
  • BS ISO 11663:2009 Quality of dialysis fluid for haemodialysis and related therapies
  • BS EN 60601-2-16:1998 Medical electrical equipment. Particular requirements for safety. Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
  • 22/30449721 DC BS EN ISO 23500-5. Preparation and quality management of fluids for haemodialysis and related therapies - Part 5. Quality of dialysis fluid for haemodialysis and related therapies
  • BS EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components. Aphaeresis blood bag systems with integrated features
  • BS 2463-1:1990 Transfusion equipment for medical use - Specification for collapsible containers for blood and blood components
  • BS ISO 27368:2011 Analysis of blood for asphyxiant toxicants. Carbon monoxide and hydrogen cyanide
  • BS ISO 27368:2008 Analysis of blood for asphyxiant toxicants. Carbon monoxide and hydrogen cyanide
  • 22/30449652 DC BS EN ISO 23500-3. Preparation and quality management of fluids for haemodialysis and related therapies - Part 3. Water for haemodialysis and related therapies

Lithuanian Standards Office , Hematology Analyzer

  • 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) )
  • LST EN ISO 25539-2:2013 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
  • LST EN ISO 25539-2:2020 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
  • LST EN ISO 25539-1:2009 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
  • LST EN ISO 25539-1:2009/AC:2011 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
  • LST EN 1060-2-2000+A1-2010 Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers

Canadian Standards Association (CSA), Hematology Analyzer

  • CSA Z8637-08-CAN/CSA-2008 Cardiovascular implants and artificial organs ?Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • CAN/CSA-ISO 8637:2012 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (First Edition)
  • CAN/CSA-ISO 8638:2013 Implants cardiovasculaires et systèmes extracorporels - Circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres (première édition)
  • CAN/CSA-ISO 8638:2012 Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (First Edition)
  • CSA ISO 8637-1:2021 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (Adopted ISO 8637-1:2017, first edition, 2017-11)
  • CSA Z8638-08-CAN/CSA-2008 Cardiovascular implants and artificial organs ?Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters First Edition [Replaced: CSA Z364.1.1/Z364.1.2-94, CSA Z364.1.1/Z364.1.2-94]
  • CSA Z364.1.1/Z364.1.2-94-1994 Hemodialyseurs, Hemofiltres Et Hemoconcentrateurs Deuxieme Edition; Fiche No 1
  • CAN/CSA-ISO 8637A:2015 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators AMENDMENT 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports (First Edition)
  • CSA C22.2 No.60601-2-16-01-2001 Medical Electrical Equipment - Part 2-16: Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment Second Edition; IEC 60601-2-16:1998
  • CSA Z364.2.1-2013 Monitoring systems for hemodialysis equipment (Third Edition)
  • CAN/CSA-ISO 13959:2015 Water for haemodialysis and related therapies (Second Edition)
  • CAN/CSA-ISO 13959:2011 Eau pour hémodialyse et thérapies apparentées (Première Édition)
  • CAN/CSA-ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies (Second Edition)

US-AAMI, Hematology Analyzer

  • 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
  • ANSI/AAMI/ISO 25539-2:2008 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
  • ANSI/AAMI/ISO 25539-2:2012 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
  • AAMI RD62-2006 Water treatment equipment for hemodialysis application
  • ANSI/AAMI 13959-2014 Water for hemodialysis and related therapies
  • ANSI/AAMI 11663-2014 Quality of dialysis fluid for haemodialysis and related therapies

Military Standards (MIL-STD), Hematology Analyzer

American National Standards Institute (ANSI), Hematology Analyzer

AT-ON, Hematology Analyzer

  • ONORM EN 1283-1996 Haemodialysers,haemodiafilters,haemofilters,haemoconcentrators and their extracorporeal circuits
  • OENORM EN ISO 25539-2:2021 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)

IN-BIS, Hematology Analyzer

  • IS 13890-1994 Haemodialysers, haemofilters and haemoconcentrators - specification
  • IS 13878-1993 Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators - specification
  • IS 10269-1982

Group Standards of the People's Republic of China, Hematology Analyzer

AENOR, Hematology Analyzer

  • UNE-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
  • 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 60601-2-16:1999 MEDICAL ELECTRICAL EQUIPMENT. PART 2-16: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT.
  • UNE 111301:1990 REQUIREMENTS OF WATER USED IN HEMODIALYSIS
  • UNE-EN ISO 25539-2:2013 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
  • UNE-EN ISO 25539-1:2009 V2 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

RU-GOST R, Hematology Analyzer

  • GOST R 52938-2008 Blood and blood components. Containers with blood or blood components. Labeling
  • GOST R ISO 8637-1999 Haemodialysers, haemofilters and haemoconcentrators. Technical requirements and test methods
  • GOST R ISO 8638-1999 Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators. Technical requirements and test methods
  • GOST ISO 8637-2012 Haemodialysers, haemofiltres and haemoconcentrators. Technical requirements and test methods
  • GOST ISO 8638-2012 Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemoconcentrators. Technical requirements and test methods
  • GOST R 53470-2009 Blood and blood components. Management on application of components of donor blood
  • GOST R 52556-2006 Water for hemodialysis. Specifications
  • GOST R 50267.16-2003 Medical electrical equipment. Part 2. Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
  • GOST R 50267.16-1993 Medical electrical equipment. Part 2. Particular requirements for safety of haemodialysis equipment
  • GOST R IEC 60601-2-16-2016 Medical electrical equipment. Part 2-16. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration
  • GOST R 53420-2009 Blood and blood components. General requirements for quality assurance of collection, processing and use of blood and blood components
  • GOST R ISO 25539-2-2012 Cardiovascular implants. Endovascular devices. Part 2. Vascular stents
  • GOST R ISO 25539-1-2012 Cardiovascular implants. Endovascular devices. Part 1. Endovascular prostheses
  • GOST R 51959.2-2002 Non-invasive sphygmomanometers (measuring devices of arterial pressure). Part 2. Supplementary requirements for mechanical sphygmomanometers
  • GOST R ISO 13958-2015 Concentrates for haemodialysis and related therapies

Jilin Provincial Standard of the People's Republic of China, Hematology Analyzer

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

中华人民共和国国家卫生和计划生育委员会, Hematology Analyzer

  • WS/T 226-2002 Guidelines for blood glucose testing by using portable blood glucose meter

HU-MSZT, Hematology Analyzer

Professional Standard - Hygiene , Hematology Analyzer

  • WS/T 405-2012 Reference intervals for blood cell analysis
  • WS/T 347-2011 Guideline for the calibration of blood cell assays
  • WS 347-2011 Calibration Guide for Blood Cell Analysis
  • WS/T 42-1996 Blood.Determination of carboxyhemoglobin.Spectrophotometric method
  • WS/T 406-2012 Analytical quality specifications for routine tests in clinical hematology

National Health Commission of the People's Republic of China, Hematology Analyzer

VN-TCVN, Hematology Analyzer

  • TCVN 7303-2-16-2007 Medical electrical equipment.Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
  • TCVN 7610-3-2007 Transfusion equipment for medical use.Part 3: Blood-taking set
  • TCVN 7611-2007 Plastics collapsible containers for human blood and blood components

卫生健康委员会, Hematology Analyzer

Standard Association of Australia (SAA), Hematology Analyzer

  • AS/NZS 3200.2.16:1999 Medical electrical equipment - Particular requirements for safety - Haemodialysis, haemodiafiltration and haemofiltration equipment
  • AS/NZS IEC 60601.2.16:2015
  • AS 4195.1:1994 Analysis of serum and plasma for trace elements - Determination of aluminium content - Graphite furnace atomic absorption spectrometric method

US-FCR, Hematology Analyzer

IT-UNI, Hematology Analyzer

International Electrotechnical Commission (IEC), Hematology Analyzer

  • 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
  • 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 60601-2-16:1998 Medical electrical equipment - Part 2-16: Particular requirements for safety of haemodialysis, haemodiafiltration and haemofiltration equipment
  • 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
  • IEC 60601-2-16/COR1:2008 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

CENELEC - European Committee for Electrotechnical Standardization, Hematology Analyzer

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

European Committee for Electrotechnical Standardization(CENELEC), Hematology Analyzer

  • 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

国家市场监督管理总局、中国国家标准化管理委员会, Hematology Analyzer

  • 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
  • GB 14232.1-2020 Plastics collapsible containers for human blood and blood components—Part 1: Conventional containers
  • GB 8369.1-2019 Transfusion sets for single use—Part 1: Gravity feed
  • GB 14232.4-2021 Plastics collapsible containers for human blood and blood components—Part 4: Aphaeresis blood bag systems with integrated features
  • GB 8369.2-2020 Transfusion sets for single use—Part 2: With pressure infusion apparatus use

Professional Standard - Agriculture, Hematology Analyzer

国家卫生计生委, Hematology Analyzer

  • WS/T 550-2017 Guidelines for quality monitoring of whole blood and blood components

国家食品药品监督管理局, Hematology Analyzer

  • YY/T 1422-2016 Serum pregnancy-related plasma protein A detection reagent (box) (quantitative labeling immunoassay)

Professional Standard - Commodity Inspection, Hematology Analyzer

  • SN/T 1672.3-2005 Rules for the inspection of medical equipment for import and export --Part 3: Transcranical Doppler blood flow analyzer

IEC - International Electrotechnical Commission, Hematology Analyzer

  • IEC 60601-2-16:2008 Medical electrical equipment – Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis@ haemodiafiltration and haemofiltration equipment (Edition 3.0)

CH-SNV, Hematology Analyzer

  • SN EN ISO 25539-2:2021 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)

PL-PKN, Hematology Analyzer

Jiangsu Provincial Standard of the People's Republic of China, Hematology Analyzer

  • DB32/T 3545.2-2020 Technical management of blood purification treatment part 2 Quality control specification for hemodialysis water treatment system

TH-TISI, Hematology Analyzer

  • TIS 1298-2012 Sterile plastic containers for human blood and blood components

Beijing Provincial Standard of the People's Republic of China, Hematology Analyzer

  • DB11/T 1963-2022 Technical specifications for quality control of instant blood gas analysis

US-CLSI, Hematology Analyzer

  • CLSI C56-A-2012 Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline

Professional Standard - Nuclear Industry, Hematology Analyzer

  • EJ/T 953-1995 Thyroid stimulating hormone Radioimmunoassay reagent kit

American Society for Testing and Materials (ASTM), Hematology Analyzer

  • ASTM E2524-08 Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
  • ASTM E2524-22 Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
  • ASTM E2524-08(2013) Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles

Professional Standard - Light Industry, Hematology Analyzer

未注明发布机构, Hematology Analyzer

CU-NC, Hematology Analyzer

  • NC 57-98-1-1986 Clinical Methods and Aids. Photometric Determination of Hemoglobin in Blood. Chemical Analysis Method

RO-ASRO, Hematology Analyzer

  • STAS SR ISO 7609:1996 Essential oils - Analysis by gas chromatography on capillary columns - General method




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