blood coagulation phase

blood coagulation phase, Total:454 items.

The international standard classification for "blood coagulation phase" includes: Surgical instruments and materials , Implants for surgery, prosthetics and orthotics , Other medical equipment , Protection against crime , Medical Sciences and health care facilities in general , Transfusion, infusion and injection equipment , Veterinary medicine , Surface active agents , Biology. Botany. Zoology .

The Chinese standard classification for "blood coagulation phase" includes: Extracorporeal circulation, artificial organ and prosthesis device , Sanitation in general , Crime judging technology , General and microsurgical devices , Animal quarantine, veterinary and epidemic prevention , Tooth paste, soap and detergent , Biological agent and blood products , Legal medical expert .

Professional Standard - Medicine

YY 0598-2015(A1) Concentrates for haemodialysis and related therapies
YY 0793.3-2023 Preparation and quality control of fluids for hemodialysis and related treatments - Part 3: Concentrates for hemodialysis and related treatments
YY 0572-2005 Water for haemodialysis and related therapies
YY 0054-2003 Haemodialysis、haemodiafiltration and haemofiltration equipment
YY 0053-2016 Hemodialysis and relavant therapics -Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
YY/T 0598-2015 Concentrates for haemodialysis and related therapies
YY 0053-2008 Cardiovascular implants and artificial organs—Haemodialysers haemodiafilters haemofilters and haemoconcentrators
YY 0572-2015 Water for haemodialysis and related therapies
YY 0793.2-2023 Preparation and quality management of fluids for haemodialysis and related therapies--Part 2:Water for haemodialysis and related therapies
YY/T 0659-2017 Blood coagulation analyzer
YY 0267-2016 Hemodialysis and related therapies―Extracorporeal blood circuit for blood purification devices
YY 0598-2015 Concentrates for haemodialysis and related therapies
YY 0598-2006 Concentrates for haemodialysis and related therapies
YY/T 1920-2023 Blood compatibility tests of haemodialysers

未注明发布机构

ANSI/AAMI/ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies—Part 3: Water for haemodialysis and related therapies
CAN/CSA-Z8638-2008 Cardiovascular Implants and Artificial Organs - Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters
DIN EN ISO 13959 E:2015-04 Water for hemodialysis and related treatments (draft)
CSA Z23500-3-2020 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
CAN/CSA-Z8637-2008 Cardiovascular Implants and Artificial Organs - Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators
ANSI/AAMI/ISO 8638:2010(2015) Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
DIN 58931 E:2021-02 Haematology - Determination of haemoglobin concentration in blood - Reference method
ANSI/AAMI/ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies—Part 5: Quality of dialysis fluid for haemodialysis and related therapies
DIN EN 1283:1996 Hemodialyzers, hemodiafilters, hemofilters, hemoconcentrators and associated LJ blood tubing systems
CSA Z23500-5-2020 Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ANSI/AAMI/ISO 8637-2:2018 Extracorporeal systems for blood purification— Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
DIN EN ISO 8637-2 E:2023-01 Extracorporeal systems for blood purification Part 2: Extracorporeal blood circuits for hemodialyzers, hemodiafilters and hemofilters (draft)
CLSI H21-2024 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays
DIN EN ISO 8637-1 E:2016-05 Extracorporeal systems for blood purification Part 1: Hemodialyzers, hemodialysis filters, hemofilters and hemoconcentrators (draft)
DIN EN ISO 11663 E:2015-05 Quality of dialysate for hemodialysis and related treatments (draft)
ANSI/AAMI/ISO 8637-1:2017 Extracorporeal systems for blood purification— Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
DIN EN ISO 13958 E:2015-05 Concentrates for hemodialysis and related therapies (draft)
DIN 58931 E:2009-03 Haematology - Determination of haemoglobin concentration in blood - Reference method
DIN 58910-1 E:2014-12 Haemostaseology - Determination of thromboplastin (prothrombin) time - Part 1: Reference measurement procedure for the determination in plasma from citrated venous blood
CSA ISO 8637-2:2021 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
DIN EN ISO 8638 E:2013-06 Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodiafilters and hemofilters for extracorporeal circulation (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 E:2016-05 Extracorporeal systems for blood purification Part 2: Extracorporeal blood circuits for hemodialyzers, hemodiafilters and hemofilters (draft)
ANSI/AAMI/ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies— Part 4: Concentrates for haemodialysis and related therapies
CSA Z23500-2-2020 Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies
ANSI/AAMI/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

Professional Standard - Public Safety Standards

GA/T 1905-2021 Forensic sciences-Examination methods for 14 anticogulantrodenticides including bromadiolone in biological samples-LC-MS
GA 657-2006 Detection method for ABO blood type in human body fluid stains—Hemagglutination inhibition test
GA/T 1632-2019 Forensic sciences—Examination methods for mepiquat and chlormequat in blood and urine samples—LC-MS
GA/T 932-2011 HPLC examination method for six anticoagulant rodenticides including diphacinone in biological samples
GA/T 1633-2019 Forensic sciences—Examination methods for ethyl glucuronide in blood and urine samples—GC-MS and LC-MS
GA/T 1629-2019 Paraquat detection in blood and urine for forensic science by gas chromatography and gas chromatography-mass spectrometry
GA/T 1320-2016 GC-MS examination methods for fluoride ion in urine and blood in forensic science
GA 656-2006 Detection method for ABO blood type in human blood(stains)—Hemagglutination test elution test

工业和信息化部

QB/T 5594-2021 Determination of tranexamic acid in cosmetics——High performance liquid chromatography

Professional Standard - Hygiene

WS/T 359-2011 Collection and processing of blood specimens for testing plasma-based coagulation assays

国家药监局

YY/T 1631.2-2020 Compatibility determination of the transfusion sets with blood component—Part 2:Assessment of damage to blood component
YY/T 0793.4-2022 Preparation and quality management of fluids for hacmodialysis andrelated therapics—Part 1:Water treatment equipment for haemodialysis applications and related therapies
YY/T 1631.1-2018 Compatibility determination of the transfusion sets with blood components―Part 1:Assessment of blood component depletion
YY/T 0793.1-2022 Preparation and quality management for liquid used in haemodialysis and related therapies—Part 1: Water treatment equipments for haemodialysis and related therapies

National Health Commission of the People's Republic of China

WST 359:2011 Guidelines for the Collection and Processing of Blood Specimens for Plasma Coagulation Tests

Professional Standard - Agriculture

618药典化学药和生物制品卷-2010 Chapter 8 Medications for Blood System Section 3 Anticoagulant Drugs, Antiplatelet Drugs and Thrombolytic Drugs 2. Antiplatelet Drug Cilostazol
1197药典二部-2020 Sodium citrate solution for anticoagulant blood
610药典化学药和生物制品卷-2010 Chapter 8 Medications for Blood System Section 3 Anticoagulant Drugs, Antiplatelet Drugs and Thrombolytic Drugs 1. Anticoagulant Drug Warfarin Sodium
604药典化学药和生物制品卷-2010 Chapter 8 Medications for the Blood System Section 3 Anticoagulant Drugs, Antiplatelet Drugs and Thrombolytic Drugs 1. Anticoagulant Drug Heparin Calcium
614药典化学药和生物制品卷-2010 Chapter 8 Medications for Blood System Section 3 Anticoagulant Drugs, Antiplatelet Drugs and Thrombolytic Drugs 2. Antiplatelet Drug Aspirin
595药典化学药和生物制品卷-2010 Chapter VIII Medications for the Blood System Section II Hemostatic and Antifibrinolytic Drugs I. Hemostatic Drugs Human Coagulation Factor Ⅷ
599药典化学药和生物制品卷-2010 Chapter VIII Drugs for Blood System Section II Hemostatic and Antifibrinolytic Drugs I. Hemostatic Drug Human Prothrombin Complex
615药典化学药和生物制品卷-2010 Chapter VIII Medications for the Blood System Section III Anticoagulant Drugs, Antiplatelet Drugs and Thrombolytic Drugs II. Antiplatelet Drug Ticlopidine Hydrochloride
611药典化学药和生物制品卷-2010 Chapter 8 Medications for Blood System Section 3 Anticoagulant Drugs, Antiplatelet Drugs and Thrombolytic Drugs 1. Anticoagulant Drug Rivaroxaban
1308药典化学药和生物制品卷-2010 Chapter 18 Biological Products 3. Blood Products Recombinant Human Coagulation Factor Ⅷ
597药典化学药和生物制品卷-2010 Chapter VIII Blood System Drugs Section II Hemostasis and Antifibrinolytic Drugs I. Hemostatic Drugs Recombinant Human Activated Coagulation Factor VII
605药典化学药和生物制品卷-2010 Chapter 8 Medications for the Blood System Section 3 Anticoagulant Drugs, Antiplatelet Drugs and Thrombolytic Drugs 1. Anticoagulant Drug Low Molecular Weight Heparin
1310药典化学药和生物制品卷-2010 Chapter 18 Biological Products 3. Blood Products Human Prothrombin Complex
1306药典化学药和生物制品卷-2010 Chapter 18 Biological Products III. Blood Products Recombinant Human Activated Coagulation Factor VII
607药典化学药和生物制品卷-2010 Chapter 8 Medications for Blood System Section 3 Anticoagulant Drugs, Antiplatelet Drugs and Thrombolytic Drugs 1. Anticoagulant Drug Enoxaparin Sodium
596药典化学药和生物制品卷-2010 Chapter VIII Blood System Medications Section II Hemostatic and Antifibrinolytic Drugs I. Hemostatic Drugs Recombinant Human Coagulation Factor Ⅷ
613药典化学药和生物制品卷-2010 Chapter 8 Medications for Blood System Section 3 Anticoagulant Drugs, Antiplatelet Drugs and Thrombolytic Drugs 1. Anticoagulant Batroxobin
1307药典化学药和生物制品卷-2010 Chapter 18 Biological Products 3. Blood Products Human Coagulation Factor Ⅷ
608药典化学药和生物制品卷-2010 Chapter VIII Drugs for Blood System Section 3 Anticoagulant Drugs, Antiplatelet Drugs and Thrombolytic Drugs 1. Anticoagulant Drug Dalteparin Sodium
609药典化学药和生物制品卷-2010 Chapter 8 Medications for Blood System Section 3 Anticoagulant Drugs, Antiplatelet Drugs and Thrombolytic Drugs 1. Anticoagulant Drug Fondaparinux Sodium*
606药典化学药和生物制品卷-2010 Chapter 8 Medications for Blood System Section 3 Anticoagulant Drugs, Antiplatelet Drugs and Thrombolytic Drugs 1. Anticoagulant Drug Nadroparin Calcium
603药典化学药和生物制品卷-2010 Chapter VIII Drugs for Blood System Section 3 Anticoagulant Drugs, Antiplatelet Drugs and Thrombolytic Drugs 1. Anticoagulant Drug Heparin Sodium
620药典化学药和生物制品卷-2010 Chapter VIII Blood System Drugs Section 3 Anticoagulant Drugs, Antiplatelet Drugs and Thrombolytic Drugs 2. Antiplatelet Drug Alprostadil
612药典化学药和生物制品卷-2010 Chapter VIII Drugs for Blood System Section III Anticoagulant Drugs, Antiplatelet Drugs and Thrombolytic Drugs I. Anticoagulant Drug Defibrase
NY/T 572-2016 Haemagglutination and haemagglutination inhibition tests for rabbit haemorrhagic disease
594药典化学药和生物制品卷-2010 Chapter 8 Medications for the Blood System Section 2 Hemostatic and Antifibrinolytic Drugs 1. Hemostatic Drug Coagulation Factor
617药典化学药和生物制品卷-2010 Chapter 8 Medications for Blood System Section 3 Anticoagulant Drugs, Antiplatelet Drugs and Thrombolytic Drugs 2. Antiplatelet Drug Dipyridamole
NY/T 572-2002 Haemagglutination and haemagglutination inhibition tests for rabbit haemorrhagic disease
619药典化学药和生物制品卷-2010 Chapter 8 Medications for Blood System Section 3 Anticoagulant Drugs, Antiplatelet Drugs and Thrombolytic Drugs 2. Antiplatelet Drug Tirofiban

Jilin Provincial Standard of the People's Republic of China

DB22/T 3049-2019 Determination of Six Mushroom Toxins in Blood and Urine by Liquid Chromatography-Tandem Mass Spectrometry
DB22/T 3258-2021 Specifications for the processing of blood routine cryoagglutination specimens

Taiwan Provincial Standard of the People's Republic of China

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

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/T 32121-2015 Determination of 4-(aminomethyl) cyclohexanecarboxylic acidtranexamic acid）in toothpaste―HPLC-MS/MS

中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

GB/T 35540-2017 Restriction thrombin

Agricultural Standard of the People's Republic of China

农业部1629号公告-2-2011 Determination of reserpine in feeds. High-performance liquid chromatography

司法部

SF/T 0113-2021 Determination of cyanide in blood by gas chromatography-mass spectrometry and gas chromatography

SCC

BS 7297-1:1990 Haemodialysers and related equipment-Specification for haemodialysers, haemofilters and haemoconcentrators
DIN 58905-1 E:2015 Draft Document - Haemostaseology - Blood collection - Part 1: Preparation of plasma from citrated venous blood for coagulation testing; Text in German and English
BS 7297-2:1990 Haemodialysers and related equipment-Specification for extracorporeal circuits for use with haemodialysers, haemofilters and haemoconcentrators
DIN 58910-1 E:2014 Draft Document - 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
AAMI/ISO 13959:2009 Water for hemodialysis and related therapies
AENOR UNE-EN 13867+A1:2009 Concentrates for hemodialysis and related therapies.
AAMI 13959:2014 Water for hemodialysis and related therapies
DANSK DS/EN ISO 13959:2015 Water for haemodialysis and related therapies
CAN/CSA Z364.1.1/Z364.1.2-1994(R2006) Haemodialysers, Haemofilters and Haemoconcentrators/ Extracorporeal Blood Circuit for Haemodialysers, Haemofilters and Haemoconcentrators
AAMI/ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 4: Concentrates for haemodialysis and related therapies
AWWA QTC97026 The Role of Coagulation in DBP-Related Risk Reduction
CAN/CSA-ISO 13959-11:2011 Water for haemodialysis and related therapies
DANSK DS/ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 4: Concentrates for haemodialysis and related therapies
CAN/CSA Z902-2004 Blood and Blood Components
CAN/CSA-Z902-2010 Blood and blood components
CAN/CSA-Z902-2004(R2009) Blood and Blood Components
AAMI 11663:2014 Quality of dialysis fluid for hemodialysis and related therapies
DANSK DS/ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 3: Water for haemodialysis and related therapies
DANSK DS/ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 5: Quality of dialysis fluid for haemodialysis and related therapies
NS-EN ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019)
CAN/CSA-ISO 11663-11:2011 Quality of dialysis fluid for haemodialysis and related therapies
AAMI/ISO 11663:2009 Quality of dialysis fluid for hemodialysis and related therapies
08/30179595 DC BS ISO 13958. Concentrates for haemodialysis and related therapies
DANSK DS/EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies
AAMI/ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 3: Water for haemodialysis and related therapies
13/30270468 DC BS ISO 13958. Concentrates for haemodialysis and related therapies
AAMI/ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 5: Quality of dialysis fluid for haemodialysis and related therapies
CAN/CSA-Z364.1.1-1994(C2006) Hemodialyzers, hemofilters and hemoconcentrators
DANSK DS/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)
NS-EN ISO 23500-4:2024 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2024)
CAN/CSA-Z364.1.1-1994(R2006) Haemodialysers, Haemofilters and Haemoconcentrators
CAN 3-Z364.1.1-M84-1984 Hemodialyzers, hemofilters and hemoconcentrators
AAMI TIR43:2021 Ultrapure dialysis fluid for hemodialysis and related therapies
CAN/CSA-Z364.1.2-1994(C2006) Extracorporeal blood circuit for hemodialyzers, hemofilters and hemoconcentrators
AAMI TIR43:2011 Ultrapure dialysate for hemodialysis and related therapies
DANSK DS/EN ISO 8637-1:2021 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
CAN/CSA-Z364.1.2-1994(R2006) Extracorporeal Blood Circuit for Haemodialysers, Haemofilters and Haemoconcentrators
NS-EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
NS-EN ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
13/30270465 DC BS ISO 11663. Quality of dialysis fluid for haemodialysis and related therapies
08/30179572 DC BS ISO 11663. Quality of dialysis fluid for haemodialysis and related therapies
DANSK DS/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)
13/30270471 DC BS ISO 13959. Water for haemodialysis and related therapies
08/30179598 DC BS ISO 13959. Water for haemodialysis and related therapies
DIN 58908 E:2014 Draft Document - Haemostaseology - Determination of activated partial thromboplastin time (APTT) - Reference measurement procedure; Text in German and English
NS-EN ISO 13959:2015 Water for haemodialysis and related therapies (ISO 13959:2014)
DANSK DS/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
AAMI/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
CSA Z902-15:2015 Blood and labile blood products
UNE-EN 1283:1996 HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS.
NS-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)
NS-EN ISO 23500-5:2024 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024)
DANSK DS/EN ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
AAMI/ISO 8637-1:2017 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
NZS 8311:1970 Method for the determination of the relative milk-coagulating power of rennet solutions
AAMI/ISO 13958:2009 Concentrates for hemodialysis and related therapies
AAMI RD16:2007 Cardiovascular implants and artificial organs - Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
AENOR UNE 23051:1971 BLOOD TRANSFUSION. LIQUID HUMAN BLOOD PLASMA
AAMI/ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
DANSK DS/EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems – Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
NS-EN 13867:2002+A1:2009 Concentrates for haemodialysis and related therapies
AAMI 13958:2014 Concentrates for hemodialysis and related therapies
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)
NS-EN ISO 8637-1:2020 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
DANSK DS/EN ISO 13958:2015 Concentrates for haemodialysis and related therapies
NS-EN 13867:2002 Concentrates for haemodialysis and related therapies
NS-EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
UNE-EN 13867:2003 Concentrates for haemodialysis and related therapies.
UNE-EN 13867:2003+A1:2009 Concentrates for haemodialysis and related therapies
CAN/CSA-ISO 13958-11:2011 Concentrates for haemodialysis and related therapies
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)
DIN EN ISO 23500-3 E:2017 Draft Document - Guidance for the preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO/DIS 23500-3:2017); German and English version prEN ISO 23500-3:2017
DIN EN ISO 23500-4 E:2017 Draft Document - Guidance for the preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO/DIS 23500-4:2017); German and English version prEN ISO 23500-4:2017
AENOR UNE-EN 13867:2003 Concentrates for hemodialysis and related therapies.
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-EN ISO 11663:2016 Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
AENOR UNE-EN ISO 13959:2016 Water for hemodialysis and related therapies. (ISO 13959:2014).
NS-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)
CAN 3-Z364.1.2-M84-1984 Extracorporeal circuits for hemodialyzers, hemofilters and hemoconcentrators
AAMI/ISO RD17:2007 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
AS 3864:1991 Medical refrigeration equipment - For the storage of blood and blood products, and containers for the transport of blood and blood products
DANSK DS/EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems – Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
DIN EN ISO 8637-1 E:2016 Draft Document - Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/DIS 8637-1:2016); German and English version prEN ISO 8637-1:2016
DIN EN ISO 23500-5 E:2017 Draft Document - Guidance for the preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/DIS 23500-5:2017); German and English version prEN I...
DIN EN ISO 8637 E:2013 Draft Document - Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010); German version FprEN ISO 8637:2013
DIN EN ISO 8637-2 E:2016 Draft Document - Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO/DIS 8637-2:2016); German and English version prEN ISO 8637-2:2016
DIN EN ISO 13959 E:2015 Draft Document - Water for haemodialysis and related therapies (ISO 13959:2014); German and English version FprEN ISO 13959:2015
AENOR UNE-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
CEI EN 60601-2-16:2018 Electrical medical equipment Part 2: Particular requirements relating to the basic safety and essential performance of hemodialysis, hemodiafiltration and haemofiltration equipment
NS-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
MIL MIL-B-37158-1975 BLOOD COLLECTING-DISPENSING BAG AND DONOR SET, DOUBLE BAG, WITH 63 CC ANTICOAGULANT, DISPOSABLE (NO S/S DOCUMENT)
AENOR UNE 23049:1971 BLOOD TRANSFUSION. PRESERVED HUMAN BLOOD
BS EN ISO 23500:2015 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
CAN/CSA-Z23500-2012 Guidelines for the preparation and quality management of fluids for hemodialysis and related therapies
DANSK DS/EN ISO 23500:2015 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
BS ISO 23500:2011 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
ISO/DIS 13959:1997 Water for Haemodialysis or Haemodiafiltration - Requirements
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
AAMI/ISO 23500:2011 Guidance for the preparation and quality management of fluids for hemodialysis and related therapies
AAMI 23500:2014 Guidance for the preparation and quality management of fluids for hemodialysis and related therapies
DANSK DS/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)

German Institute for Standardization

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 58910-4:2000-03 Haemostaseology - Determination of thromboplastin (prothrombin) time - Part 4: Reference measurement procedure for the determination in capillary blood
DIN 58911-1:2000-03 Haemostaseology - Calibration of measurement procedures - Part 1: Clotting time measurement procedures
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 58910-2:2000-03 Haemostaseology - Determination of thromboplastin (prothrombin) time - Part 2: Reference measurement procedure for the determination in citrated venous blood
DIN EN ISO 23500-4:2022-12 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO/DIS 23500-4:2022); German and English version prEN ISO 23500-4:2022 / Note: Date of issue 2022-11-1...
DIN EN ISO 23500-4:2019-11 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019); German version EN ISO 23500-4:2019 / Note: To be replaced by DIN EN ISO 23500-4 (202...
DIN EN ISO 23500-3:2019-11 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019); German version EN ISO 23500-3:2019 / Note: To be replaced by DIN EN ISO 23500-3 (2022-12).
DIN EN ISO 23500-3:2022-12 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO/DIS 23500-3:2022); German and English version prEN ISO 23500-3:2022 / Note: Date of issue 2022-11-18*Inten...
DIN EN ISO 23500-5:2019-11 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019); German version EN ISO 23500-5:2019 / Note: To be replaced by DIN EN ISO...
DIN EN ISO 23500-5:2022-12 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/DIS 23500-5:2022); German and English version prEN ISO 23500-5:2022 / Note: Date of is...
DIN EN ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019)
DIN 58908:2015-09 Haemostaseology - Determination of activated partial thromboplastin time (APTT) - Reference measurement procedure; 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 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 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 EN ISO 23500-2:2022-12 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO/DIS 23500-2:2022); German and English version prEN ISO 23500-2:2022 / Not...
DIN EN ISO 13959:2016 Water for haemodialysis and related therapies (ISO 13959:2014)
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 ...
DIN 58913-1:2000-03 Haemostaseology - Determination of factor II coagulant activity (F II C) and factor X coagulant activity (F X C) - Part 1: Reference measurement procedure for the one-stage method
DIN EN ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
DIN EN ISO 23500-4:2017 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO/DIS 23500-4:2017); German and English version prEN ISO 23500-4:2017
DIN EN ISO 8637-2:2018-12 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018); German version EN ISO 8637-2:2018 / Note: To be replaced by DIN EN ISO 8637-2 (2023-01).
DIN EN ISO 8637-2:2023-01 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/DIS 8637-2:2022); German and English version prEN ISO 8637-2:2022 / Note: Date...
DIN EN ISO 23500-3:2017 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO/DIS 23500-3:2017); German and English version prEN ISO 23500-3:2017
DIN 58910-4:2000 Haemostaseology - Determination of thromboplastin (prothrombin) time - Part 4: Reference measurement procedure for the determination in capillary blood
DIN 58934-1:1997 Haematology - Control material for the CBC - Part 1: Control bloods
DIN 12750:1969 Blood dilution pipettes for blood corpuscles counting
DIN EN ISO 23500-5:2017 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/DIS 23500-5:2017); German and English version prEN ISO 23500-5:2017
DIN EN ISO 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)
DIN 58931:1995 Haematology - Determination of haemoglobin concentration in blood - Reference method
DIN EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
DIN 58931:2021-09 Haematology - Determination of haemoglobin concentration in blood - Reference method; Text in German and English
DIN 58931:2021 Haematology - Determination of haemoglobin concentration in blood - Reference method; Text in German and English
DIN 12750:1969-02 Blood dilution pipettes for blood corpuscles counting
DIN 58909-1:2020-04 Haemostaseology - Determination of factor VIII coagulant activity (FVIII:C) - Part 1: Reference measurement procedure for the one-stage method; Text in German and English
DIN 58909-1:2020 Haemostaseology - Determination of factor VIII coagulant activity (FVIII:C) - Part 1: Reference measurement procedure for the one-stage method; Text in German and English
DIN EN ISO 13958:2016 Concentrates for haemodialysis and related therapies (ISO 13958:2014)

British Standards Institution (BSI)

BS EN ISO 23500-4:2024 Preparation and quality management of fluids for haemodialysis and related therapies - Concentrates for haemodialysis and related therapies
BS EN ISO 23500-3:2024 Preparation and quality management of fluids for haemodialysis and related therapies - Water for haemodialysis and related therapies
BS ISO 13959:2014 Water for haemodialysis and related therapies
BS EN ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies. Water for haemodialysis and related therapies
BS ISO 13959:2009 Water for haemodialysis and related therapies
BS EN ISO 13959:2015 Water for haemodialysis and related therapies
BS EN ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies. Quality of dialysis fluid for haemodialysis and related therapies
BS EN ISO 23500-5:2024 Preparation and quality management of fluids for haemodialysis and related therapies - Quality of dialysis fluid for haemodialysis and related therapies
BS EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies
BS EN ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies. Concentrates for haemodialysis and related therapies
BS EN ISO 23500-2:2024 Preparation and quality management of fluids for haemodialysis and related therapies - Water treatment equipment for haemodialysis applications and related therapies
BS ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies
BS ISO 11663:2009 Quality of dialysis fluid for haemodialysis and related therapies
BS EN ISO 8637-1:2020 Extracorporeal systems for blood purification. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
22/30449717 DC BS EN ISO 23500-4. Preparation and quality management of fluids for haemodialysis and related therapies - Part 4. Concentrates for haemodialysis and related therapies
22/30449721 DC BS EN ISO 23500-5. Preparation and quality management of fluids for haemodialysis and related therapies - Part 5. Quality of dialysis fluid for haemodialysis and related therapies
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
BS EN ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies. Water treatment equipment for haemodialysis applications and related therapies
BS EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
BS EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
BS EN ISO 8637-2:2024 Extracorporeal systems for blood purification - Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
BS EN ISO 8637-2:2018 Extracorporeal systems for blood purification. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
23/30470631 DC BS ISO 8637-1. Extracorporeal systems for blood purification - Part 1. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
12/30254337 DC BS ISO 8637 AMD1. Cardiovascular implants and extracorporeal systems. 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
16/30331650 DC BS EN ISO 8637-1. Extracorporeal systems for blood purification. Part 1. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
22/30449648 DC BS EN ISO 23500-2. Preparation and quality management of fluids for haemodialysis and related therapies - Part 2. Water treatment equipment for haemodialysis applications and related therapies
BS ISO 26722:2009 Water treatment equipment for haemodialysis applications and related therapies
BS ISO 23500:2014 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
BS ISO 26722:2014 Water treatment equipment for haemodialysis applications and related therapies
BS EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

North Atlantic Treaty Organization Standards Agency

STANAG 2939-2000 MEDICAL REQUIREMENTS FOR BLOOD, BLOOD DONORS AND ASSOCIATED EQUIPMENT

International Organization for Standardization (ISO)

ISO 13958:2014 Concentrates 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 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
ISO 13959:2009 Water for haemodialysis and related therapies
ISO 13959:2014 Water for haemodialysis and related therapies
ISO/FDIS 23500-4:2011 Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
ISO 8638:1989 Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators
ISO/DIS 23500-3 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
ISO 8637:1989 Haemodialysers, haemofilters and haemoconcentrators
ISO/DIS 23500-5 Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ISO 11663:2014 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 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 8637-1:2023 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 13958:2009 Concentrates for haemodialysis and related therapies
ISO 13958:2002 Concentrates for haemodialysis and related therapies
ISO/CD 8637-1 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO/DIS 8637-1 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/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 8637-2:2024 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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 8637:2010 Cardiovascular implants and extracorporeal systems - 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 8638:2004 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ISO 8637:2004 Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ISO 23500-3:2024 Preparation and quality management of fluids for haemodialysis and related therapies
ISO 23500-4:2024 Preparation and quality management of fluids for haemodialysis and related therapies
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 23500-5:2024 Preparation and quality management of fluids for haemodialysis and related therapies
ISO 11663:2009 Quality of dialysis fluid for haemodialysis and related therapies
ISO 23500:2011 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
ISO 26722:2014 Water treatment equipment for haemodialysis applications and related therapies

Association Francaise de Normalisation

NF EN ISO 23500-4:2019 Preparation and quality management of hemodialysis fluids and related therapies - Part 4: concentrates for hemodialysis and related therapies
NF S93-305-3*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 Preparation and quality management of hemodialysis fluids and related therapies - Part 3: water for hemodialysis and related therapies
NF S93-305-5*NF EN ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5 : quality of dialysis fluid for haemodialysis and related therapies
NF EN ISO 23500-5:2019 Preparation and quality management of hemodialysis fluids and related therapies - Part 5: quality of dialysis fluids for hemodialysis and related therapies
NF 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 S93-301:2009 Concentrates for haemodialysis and related therapies.
NF S93-301/IN1:2009 Concentrates for haemodialysis and related therapies.
NF U47-210:2016 Animal health analysis methods - Isolation of hemagglutinating avian myxoviruses by ovoculture and detection of their hemagglutinating activity
NF EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
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 S93-302*NF EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
NF EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
NF EN ISO 23500-2:2019 Preparation and quality management of fluids for hemodialysis and related therapies - Part 2: water treatment equipment for applications in hemodialysis and related therapies
NF S93-302-1*NF EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1 : haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
NF S93-302-2*NF EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2 : extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
NF S93-303:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

NATO - North Atlantic Treaty Organization

STANAG 2939-2010 MINIMUM REQUIREMENTS FOR BLOOD@ BLOOD DONORS AND ASSOCIATED EQUIPMENT (ED 5)

ZA-SANS

SANS 5064:1975 Anticoagulant acid citrate dextrose solution, identification of

Korean Agency for Technology and Standards (KATS)

KS P ISO 13959-2009(2019) Water for haemodialysis and related therapies
KS P ISO 13959-2021 Water for haemodialysis and related therapies
KS P ISO 23500-4:2021 Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates 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 4907-2013 Haemodialysers, haemofilters and haemoconcentrators
KS P ISO 11663-2022 Quality of dialysis fluid for haemodialysis and related therapies
KS P ISO 8638:2012 Cardiovascular implants and extracorporeal systems －Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
KS P ISO 13958:2009 Concentrates for haemodialysis and related therapies
KS P ISO 8637:2012 Cardiovascular implants and extracorporeal systems－Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P ISO 13958-2009(2019) Concentrates for haemodialysis and related therapies
KS P ISO 8637-1-2023 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P ISO 8638-2012(2017) Cardiovascular implants and extracorporeal systems －Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
KS P 4907-2011 Haemodialysers, haemofilters and haemoconcentrators
KS P ISO 13958-2021 Concentrates for haemodialysis and related therapies
KS P ISO 8637-2023 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 P ISO 11663:2010 Quality of dialysis fluid for haemodialysis and related therapies
KS P ISO 11663:2017 Quality of dialysis fluid for haemodialysis and related therapies
KS P ISO 8637:2018 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

RO-ASRO

STAS 11326/2-1985 RUBBER STOPPERS FOR BLOOD, PLASMA AND AQUEOUS SOLUTION BOTTLES FOR INJECTIONS AND PERFUSIONS Pyrogenic impurities checking up

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 13959:2009 Water for hemodialysis and related therapies
CAN/CSA Z902-2020 Blood and blood components
ANSI/AAMI/ISO 11663:2009 Quality of dialysis fluid for haemodialysis and related therapies
ANSI/AAMI/ISO 13958:2009 Concentrates for hemodialysis and related therapies
ANSI/AAMI/ISO 26722:2009 Water treatment equipment for hemodialysis applications and related therapies
ANSI/AAMI/ISO 11663(Ed1):2009 Quality of dialysis fluid for haemodialysis and related therapies
ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ANSI/AAMI/ISO 23500:2011 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies

ES-UNE

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)
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 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019)
UNE-EN 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 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
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)
ISO/FDIS 23500-2:2023 Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies
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)

GSO

BH GSO ISO 13959:2017 Water for haemodialysis and related therapies
GSO ISO 11663:2021 Quality of dialysis fluid for haemodialysis and related therapies
BH GSO ISO 11663:2022 Quality of dialysis fluid for haemodialysis and related therapies
ISO 23500-2:2024 Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies
OS GSO ISO 8637:2016 Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
BH GSO ISO 13958:2017 Concentrates for haemodialysis and related therapies
GSO ISO 8637:2016 Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
OS GSO ISO 8638:2016 Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
GSO ISO 8638:2016 Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
BH GSO ISO 8637:2017 Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
GSO ISO 13958:2016 Concentrates for haemodialysis and related therapies
BH GSO ISO 8638:2017 Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
OS GSO ISO 13958:2016 Concentrates for haemodialysis and related therapies
OS GSO ISO 23500:2016 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
GSO ISO 23500:2016 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
BH GSO ASTM F2888:2023 Standard Practice for Platelet Leukocyte Count — An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
BH GSO ISO 23500:2017 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
GSO ASTM F2888:2023 Standard Practice for Platelet Leukocyte Count — An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials

KR-KS

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 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 8637-2-2022 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 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

US-AAMI

ANSI/AAMI 13959-2014 Water for hemodialysis and related therapies
ANSI/AAMI 11663-2014 Quality of dialysis fluid for haemodialysis and related therapies
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 13958-2014 Concentrates for hemodialysis and related therapies
ANSI/AAMI RD17-2007 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
AAMI 23500-2014 Guidance for the preparation and quality management of fluids for hemodialysis and related therapies

ES-AENOR

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

CEN - European Committee for Standardization

EN ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
EN ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
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 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers@ haemodiafilters and haemofilters

Canadian Standards Association (CSA)

CAN/CSA-ISO 13958:2015 Concentrates for haemodialysis and related therapies (Second Edition)
CAN/CSA-ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies (Second 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)
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 Z902-04-CAN/CSA-2004 Sang et produits sanguins labiles Premiere Edition
CSA Z364.1.1/Z364.1.2-94-1994 Hemodialyseurs, Hemofiltres Et Hemoconcentrateurs Deuxieme Edition; Fiche No 1
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)

Japanese Industrial Standards Committee (JISC)

JIS T 3250:2022 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
JIS T 3250:2005 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
JIS T 3250:2011 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
JIS T 3250:2013 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

European Committee for Standardization (CEN)

EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
FprEN ISO 23500-4 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO/FDIS 23500-4:2024)
prEN ISO 23500-4 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO/DIS 23500-4:2022)
FprEN ISO 23500-3 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO/FDIS 23500-3:2024)
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)
FprEN ISO 23500-5 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/FDIS 23500-5:2024)
prEN ISO 23500-5 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/DIS 23500-5:2022)
EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
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 1283:1996 Haemodialysers, Haemodiafilters, Haemofilters, Haemoconcentrators and Their Extracorporeal Circuits
EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers@ haemodiafilters and haemofilters
prEN ISO 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/DIS 23500-2:2022)
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)

RU-GOST R

GOST 33674-2015 Blood and processed products. Specifications
GOST R 53470-2009 Blood and blood components. Management on application of components of donor blood
GOST R ISO 13958-2015 Concentrates for haemodialysis and related therapies
GOST R 52938-2008 Blood and blood components. Containers with blood or blood components. Labeling
GOST R ISO 8638-1999 Extracorporeal blood circuit for haemodialysers, haemofilters 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 ISO 8637-2012 Haemodialysers, haemofiltres and haemoconcentrators. Technical requirements and test methods

US-FCR

FCR 21 CFR PART 630-2013 GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES
FCR 21 CFR PART 630-2015 GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES
FCR 21 CFR PART 640-2015 ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
FCR 21 CFR PART 640-2013 ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
FCR 21 CFR PART 640-2014 ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS

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 13867+A1:2009 Concentrates for haemodialysis and related therapies

CZ-CSN

CSN ISO 8638:1994 Extracorporeal blood circuit for haemodialysers,haemofilters and haemoconcentrators
CSN ISO 8637:1994 Haemodialysers, haemofilters and haemoconcentrators
CSN 70 3351-1979 Bottles for blood and transfusion and infusion preparations

IN-BIS

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

Lithuanian Standards Office

LST EN 1283-2001 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
LST EN 13867-2004+A1-2009 Concentrates for haemodialysis and related therapies

Indonesia Standards

SNI ISO 8638:2012 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

AT-ON

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

DIN

DIN EN 13867:2003 Concentrates for haemodialysis and related therapies

SE-SIS

SIS SS 87 511 06-1989 Infusion sets for blood

AENOR

UNE-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)

American Society for Testing and Materials (ASTM)

ASTM F1830-97(2017) Standard Practice for Selection of Blood for in vitro Evaluation of Blood Pumps

YU-JUS

JUS B.E4.095-1981 Bottles for conservated human blood, derivate of blood, parenteral solution and water for injections

HU-MSZT

MSZ KGST 729-1977 Bottles of blood, blood transfusions and infusion items

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