blood slicer

blood slicer, Total:421 items.

The international standard classification for "blood slicer" includes: Transfusion, infusion and injection equipment , Commercial refrigerating appliances , Health care technology (Vocabularies) , Surgical instruments and materials , Implants for surgery, prosthetics and orthotics , Laboratory medicine , Medical equipment , Other medical equipment , Medical Sciences and health care facilities in general .

The Chinese standard classification for "blood slicer" includes: Extracorporeal circulation, artificial organ and prosthesis device , Refrigeration equipment , General and microsurgical devices , Medical optical instrument and endoscope , Medical laboratory equipment , Public medical equipment , Medical radiographic equipment , Sanitation in general , Medical science .

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 13074-2024 Blood purification terminology
GB 14232.1-2004 Plastics collapsible containers for human blood and blood components?Part 1:Conventional containers
GB/T 13074-2009 Terms of blood purification
GB 14232.1-2020 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
GB/T 13074-1991 Terms of blood purification Hemodialysis and hemofiltration
GB/T 21278-2007 Refrigerators for conserved blood

Taiwan Provincial Standard of the People's Republic of China

CNS 14193-1998 Haemodialysers,hasmofilters and haemoconcentrators
CNS 15036-1-2006 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers
CNS 14194-1998 Extracorporeal blood circuit for haemodialysers hasmofilters and haemoconcentrators

Professional Standard - Medicine

YY/T 0653-2008 Hematology analyzer
YY 0054-2003 Haemodialysis、haemodiafiltration and haemofiltration equipment
YY/T 0848-2011 Blood irradiator
YY/T 1631.2-2020 Compatibility determination of the transfusion sets with blood component—Part 2:Assessment of damage to blood component
YY/T 0653-2017 Hematology analyzer
YY 0054-2023 Haemodialysis equipment
YY 0054-2010 Haemodialysis equipment
YY 0790-2024 Hemoperfusion equipment
YY 0790-2010 Hemoperfusion equipment
YY/T 1631.1-2018 Compatibility determination of the transfusion sets with blood components―Part 1:Assessment of blood component depletion
YY/T 1945-2025 Blood Thawing Device
YY/T 0700-2008 Clothing for protection against contact with blood and body fluids—Determination of the resistance of protective clothing materials to penetration by blood and body fluids—Test method using synthetic blood
YY 0168-1994 Refrigerators for conserved blood
YY 0267 Extracorporeal circulation system for blood purification, extracorporeal blood circuit/liquid circuit for hemodialysis, hemodiafiltration, hemofiltration, and hemocentration devices
YY/T 1545-2017 Evaluation of connection between haemodialysis concentrate and haemodialysis equipment
YY/T 1460-2016 Blood rheometer
YY/T 0168-2007 Blood refrigerator
YY 0267-2025 Extracorporeal circulation blood circuit/fluid circuit for blood purification extracorporeal circulation system hemodialyzer, hemodialysis filter, hemofilter and hemoconcentrator
YY 0267-2016 Hemodialysis and related therapies―Extracorporeal blood circuit for blood purification devices
YY/T 0500-2021 Cardiovascular implants and extracorporeal systems-vascular prostheses-tubular vascular grafts and vascular patches
YY 0053-2016 Hemodialysis and relavant therapics -Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
YY 0267-1995 Extracorporeal blood circuit for blood purification devices
YY 0053-2008 Cardiovascular implants and artificial organs—Haemodialysers haemodiafilters haemofilters and haemoconcentrators

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

JJF 2266-2025 Calibration Specification for Blood Melting Machines

Professional Standard - Agriculture

660药典中药成方制剂卷-2010 Each chapter on Internal Medicine XV. Blood Regulating Agents (1) Activating Blood and Removing Blood Stasis Xuesaitong Granules (tablets)
药品检验补充检验方法和检验项目批准件编号2013006 Dried Blood Herbs (Pieces)
219药典一部-2020 Medicinal materials and decoction pieces
8药典三部-2010 General headings Human plasma for the production of blood products
1123药典中药成方制剂卷-2010 Monographs on Dermatology IV, Cooling Blood, Promoting Blood and Xiaoyin Granules (Tablets)
药品检验补充检验方法和检验项目批准件编号2011013 Huoxue Zhitong Powder (capsule, tablet)
681药典中药成方制剂卷-2010 Sections on Internal Medicine XV. Blood Regulating Agents (2) Xingqi Huoxue Yuanhu Zhitong Tablets (Soft Capsules, Granules, Oral Liquids, Dropping Pills)
784药典中药成方制剂卷-2010 Various Discussions on Internal Medicine 15. Blood Regulating Agents (6) Activating Blood, Resolving Phlegm, Xifeng, and Naoxuekang Capsules (Tablets)
794药典中药成方制剂卷-2010 Various Discussions on Internal Medicine 15. Blood Regulating Agents (7) Hemostasis Radix Notoginseng Tablets
546药典化学药和生物制品卷-2010 Chapter 7 Drugs for the Urinary System Section 2 Dialysate for Blood Purification and Replacement Fluid Hemodialysate
547药典化学药和生物制品卷-2010 Chapter 7 Drugs for the Urinary System Section 2 Dialysate and Replacement Fluid for Blood Purification Hemofiltration Replacement Fluid
789药典中药成方制剂卷-2010 Sections on Internal Medicine 15. Blood Regulating Agents (7) Zhixuekang Oral Liquid
219药典一部-2015 Medicinal materials and decoction pieces
793药典中药成方制剂卷-2010 Sections on Internal Medicine 15. Blood Regulating Agents (7) Hemostasis, Hemostasis and Pain Relief Tablets
799药典中药成方制剂卷-2010 Various Discussions on Internal Medicine 15. Blood Regulating Agents (7) Hemostatic Nudehua Zizhu Tablets
705药典中药成方制剂卷-2010 Various Discussions on Internal Medicine 15. Blood Regulating Agents (2) Promoting Qi and Activating Blood Blood Di'ao Xinxuekang Capsules (tablets)
653药典中药成方制剂卷-2010 Sections on Internal Medicine 15. Blood Regulating Agents (1) Ginkgo Leaf Capsules for Promoting Blood and Removing Blood Stasis (Oral Liquid, Tablets)
671药典中药成方制剂卷-2010 Sections on Internal Medicine 15. Blood Regulating Agents (1) Activating Blood and Dispelling Blood Stasis Dachuanxiong Granules (Oral Liquid, Pills, Tablets)
798药典中药成方制剂卷-2010 Sections on Internal Medicine 15. Blood Regulating Agents (7) Hemostatic Purple Beads to Stop Hemorrhage
药品检验补充检验方法和检验项目批准件编号2009017 Compound Reserpine Tablets
220药典一部-2010 Medicinal materials and decoction pieces

Jilin Provincial Standard of the People's Republic of China

DB22/T 2196-2014 Specifications for quality control of water for hemodialysis and hemodialysis fluid
DB22/T 2915-2018 Technical requirements for blood testing of blood donor dogs
DB22/T 2031-2014 Specifications for Quality Control of Hemodialysis Machines

Anhui Provincial Standard of the People's Republic of China

DB34/T 4240-2022 Service Specifications for Third-Party Blood Testing Institutions

Jiangsu Provincial Standard of the People's Republic of China

DB32/T 3545.4-2021 Technical Management of Blood Purification Therapy Part 4: Medical Quality Management Standards for Blood Purification Medical Institutions
DB32/T 3545.3-2021 Technical management of blood purification therapy part 3: training norms for medical staff in blood purification medical institutions
DB32/T 3545.5-2023 Standards for blood purification therapy―Part 5:Code of practice of emergency procedure for blood purification center
DB32/T 3545.1-2019 Technical management of blood purification therapy part 1 Infection management norms in blood purification therapy institutions

Group Standards of the People's Republic of China

T/CITS 162-2024 Specifications for remote intelligent blood management in medical institutions
T/CSBME 057-2022 Adsorption resin for hemoperfusion or plasma perfusion devices
T/CSBT 002-2019 Guideline for reentry of reactive blood donors in blood screening test

未注明发布机构

CLSI GP42-2020 Collection of Capillary Blood Specimens

Professional Standard - Hygiene

WS/T 400-2012 Requirements for blood transportation
WS/T 399-2023 blood storage standards
WS 399-2012 Standards for blood storage
WS/T 400-2023 blood transport standards

Military Standards (MIL-STD)

MIL MIL-B-37328-1975 BLOOD DETECTION TABLETS (NO S/S DOCUMENT)
DOD A-A-54473-1991 CENTRIFUGE, LABORATORY (HEMATOLOGY)
DOD A-A-51342-1986 SHAKING MACHINE, LABORATORY, (BLOOD COLLECTING TUBE)
DOD A-A-53971-1989 CUFF, BLOOD WARMER
DOD A-A-54872-1993 BLOOD EXCHANGE-TRANSFUSION KIT, DISPOSABLE
DOD A-A-54126-1990 PIPET-DILUENT, BLOOD, LABORATORY
DOD A-A-54504-1991 ANALYZER, BLOOD GAS

International Organization for Standardization (ISO)

ISO 8637-1:2024 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8638:1989 Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators
ISO 8637:1989 Haemodialysers, 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/CD 8637-1 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO/FDIS 8637-1:2023 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637:2010 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637-2:2024 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ISO 8637-1:2017 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637:2004 Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, 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/DIS 13959:1997 Water for Haemodialysis or Haemodiafiltration - Requirements
ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features
ISO 7199:1996 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
ISO 3826:1993 Plastics collapsible containers for human blood and blood components
ISO/DIS 13958:1997 Concentrates for Haemodialysis or Haemodiafiltration
ISO 7198:2016 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
ISO/CD 3826-4:2024 Plastics collapsible containers for human blood and blood components
ISO/CD 3826-3:2024 Plastics collapsible containers for human blood and blood components
ISO/CD 3826-2:2024 Plastics collapsible containers for human blood and blood components
ISO 16603:2004 Clothing for protection against contact with blood and body fluids - Determination of the resistance of protective clothing materials to penetration by blood and body fluids - Test method using synthetic blood
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

Canadian Standards Association (CSA)

CAN/CSA Z364.1.1/Z364.1.2-1994(R2006) Haemodialysers, Haemofilters and Haemoconcentrators/ Extracorporeal Blood Circuit for Haemodialysers, Haemofilters and Haemoconcentrators
CAN/CSA-Z902-2010 Blood and blood components
CAN/CSA Z902-2004 Blood and Blood Components
CAN/CSA-Z902-2004(R2009) Blood and Blood Components
CAN/CSA Z902-2020 Blood and blood components
CAN/CSA Z902-2025 Blood and blood components
CAN/CSA-Z364.1.1-1994(C2006) Hemodialyzers, hemofilters and hemoconcentrators
CAN/CSA-ISO 8637-2012(R2017) Cardiovascular implants and extracorporeal systems Hemodialyzers, hemofilters, blood filters and concentrators
CAN/CSA-Z364.1.1-1994(R2006) Haemodialysers, Haemofilters and Haemoconcentrators
CAN/CSA-Z364.1.2-1994(R2006) Extracorporeal Blood Circuit for Haemodialysers, Haemofilters and Haemoconcentrators
CAN/CSA-Z364.1.2-1994(C2006) Extracorporeal blood circuit for hemodialyzers, hemofilters and hemoconcentrators
CSA ISO 8637-2:2021 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
CAN/CSA-Z8637-2008 Cardiovascular Implants and Artificial Organs - Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators
CSA Z8637-08-CAN/CSA-2008 Cardiovascular implants and artificial organs ?Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
CSA Z902-15:2015 Blood and labile blood products
CAN/CSA-ISO 8637-2-2021 Extracorporeal systems for blood purification – Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018, IDT)
CAN/CSA-ISO 8637-1-2021 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017, IDT)
CAN/CSA-Z8638-2008 Cardiovascular Implants and Artificial Organs - Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters
CAN/CSA-ISO 8638:2013 Implants cardiovasculaires et systèmes extracorporels - Circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres (première édition)
CAN/CSA-ISO 8638:2012 Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (First Edition)
CAN/CSA-ISO 8637:2012 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (First Edition)
CSA Z902-04-CAN/CSA-2004 Sang et produits sanguins labiles Premiere 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 Z364.1.1/Z364.1.2-94-1994 Hemodialyseurs, Hemofiltres Et Hemoconcentrateurs Deuxieme Edition; Fiche No 1
CSA Z902-2009 Blood and Blood Components *** TEMPORARILY REMOVED FROM DISTRIBUTION PER CSA
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]
CAN/CSA Z8637-2008 Cardiovascular Implants and Artificial Organs - Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators (Adopted ISO 8637:2004, second edition, 2004-10-01, with Canadian deviations)
CSA Z902-2004 Blood and Blood Components First Edition; Update 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)
CAN/CSA Z8638-2008 Cardiovascular Implants and Artificial Organs - Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters (Adopted ISO 8638:2004, second edition, 2004-10-01, with Canadian deviations)
CSA Z364.2.1-1994(R2011) Fluid Supply and Monitoring Systems for Haemodialysis

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
JIS T 3217:2011 Plastic collapsible containers for human blood and blood components
JIS T 3232:2005 Blood filters for cardiopulmonary bypass systems
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 8060:2007 Clothing for protection against contact with blood and body fluids -- Determination of the resistance of protective clothing materials to penetration by blood and body fluids -- Test method using synthetic blood
JIS T 3248:2022 Extracorporeal blood circuit
JIS T 3248:2012 Extracorporeal blood circuit
JIS T 3248:2011 Extracorporeal blood circuit
JIS T 3217:2023 Plastic collapsible containers for human blood and blood components
JIS T 3248:2005 Extracorporeal blood circuit
JIS T 8060:2015 Clothing for protection against contact with blood and body fluids -- Determination of the resistance of protective clothing materials to penetration by blood and body fluids -- Test method using synthetic blood
JIS T 3232:2016 Blood filters for cardiopulmonary bypass systems
JIS T 3232:2011 Blood filters for cardiopulmonary bypass systems

Spanish Association for Standardization (UNE)

UNE 111-325-1989 Hemodialysis, blood filters and blood hubs
UNE-EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
UNE-EN 1283:1996 HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS.
UNE-EN ISO 8637-2:2019 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
UNE 111-350-1989 Hemodialysis, extracorporeal circulation with blood filters and blood hubs
AENOR UNE 23051:1971 BLOOD TRANSFUSION. LIQUID HUMAN BLOOD PLASMA
UNE-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
AENOR UNE-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
AENOR UNE 23049:1971 BLOOD TRANSFUSION. PRESERVED HUMAN BLOOD
UNE-EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
AENOR UNE-EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
UNE-EN 60601-2-16:1999 MEDICAL ELECTRICAL EQUIPMENT. PART 2-16: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT.
AENOR UNE-EN 60601-2-16:1999 Electromedical equipment. Part 2-16: Particular requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration equipment.

Korean Agency for Technology and Standards (KATS)

KS P ISO 8637:2012 Cardiovascular implants and extracorporeal systems－Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P 4907-2013 Haemodialysers, haemofilters and haemoconcentrators
KS P ISO 8638:2012 Cardiovascular implants and extracorporeal systems －Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
KS P ISO 8637-1-2023 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P 4907-2011 Haemodialysers, haemofilters and haemoconcentrators
KS P ISO 8637-2-2022 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
KS P ISO 8638-2012(2017) Cardiovascular implants and extracorporeal systems －Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
KS P ISO 8637-2023 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P ISO 8638-2022 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 P ISO 8637:2018 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P ISO 7199:2012 Cardiovascular implants and artificial organs－Blood-gas exchangers(oxygenators)
KS K ISO 16603-2012(2022) Clothing for protection against contact with blood and body fluids－Determination of the resistance of protective clothing materials to penetration by blood and body fluids－Test method using synthetic
KS C IEC 60601-2-16:2002 Haemodialysis, haemodiafiltration and haemofiltration equipment
KS P ISO 7198:2018 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
KS P ISO 7198-2018 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
KS K ISO 16603:2012 Clothing for protection against contact with blood and body fluids-Determination of the resistance of protective clothing materials to penetration by blood and body fluids-Test method using synthetic blood
KS P ISO 7198-2018(2023) Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
KS K ISO 16603-2023 Clothing for protection against contact with blood and body fluids — Determination of the resistance of protective clothing materials to penetration by blood and body fluids — Test method using synthetic blood
KS P ISO 3826-4-2019(2024) Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features

Association Francaise de Normalisation

NF S93-302-2*NF EN ISO 8637-2:2024 Extracorporeal systems for blood purification - Part 2 : extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
NF EN ISO 8637-2:2024 Extracorporeal systems for blood purification - Part 2 : extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
NF EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
NF EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
NF S93-302*NF EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - 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 S93-302-1*NF EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1 : haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
NF S93-303:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
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 S94-204*NF EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems - Vascular Prostheses - Tubular vascular grafts and vascular patches
NF EN ISO 3826-1:2019 Poches en plastique souple pour le sang et les composants du sang - Partie 1 : poches conventionnelles

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 607-2014 ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
FCR 21 CFR PART 607-2013 ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
FCR 21 CFR PART 607-2015 ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
FCR 21 CFR PART 640-2013 ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
FCR 21 CFR PART 640-2015 ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
FCR 21 CFR PART 640-2014 ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
FCR 21 CFR PART 606-2015 CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
FCR 21 CFR PART 606-2013 CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
FCR 21 CFR PART 606-2014 CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS

SCC

CAN 3-Z364.1.1-M84-1984 Hemodialyzers, hemofilters and hemoconcentrators
AAMI/ISO 8637:2010(R2015) Cardiovascular implants and extracorporeal systems - Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
AAMI/ISO 8637-1:2017 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
AAMI/ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
AAMI/ISO 8638:2010(R2015) Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
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
AAMI/ISO 7198:2016 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches

Gosstandart of Russia

GOST 33674-2015 Blood and processed products. Specifications
GOST R 52938-2008 Blood and blood components. Containers with blood or blood components. Labeling
GOST R 53470-2009 Blood and blood components. Management on application of components of donor blood
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
GOST R ISO 8637-1999 Haemodialysers, haemofilters and haemoconcentrators. Technical requirements and test methods
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 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

Ente Nazionale Italiano di Unificazione

UNI EN ISO 8637-2:2024 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
UNI EN 1283:1998 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
UNI EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
UNI EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
UNI EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
UNI EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
UNI EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features
UNI EN ISO 3826-3:2008 Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features
UNI EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
UNI EN ISO 3826-1:2004 Plastics collapsible containers for human blood and blood components - Conventional containers

British Standards Institution (BSI)

BS EN ISO 8637-1:2020 Extracorporeal systems for blood purification. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
BS 7297-1:1990 Haemodialysers and related equipment-Specification for haemodialysers, haemofilters and haemoconcentrators
BS EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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
BS EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
25/30513023 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
BS EN ISO 8637-2:2024 Extracorporeal systems for blood purification - Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
25/30515248 DC BS EN ISO 8637-2 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
22/30456450 DC BS EN ISO 8637-2. Extracorporeal systems for blood purification - Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
BS EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components. Aphaeresis blood bag systems with integrated features
16/30331650 DC BS EN ISO 8637-1. Extracorporeal systems for blood purification. Part 1. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
BS 7297-2:1990 Haemodialysers and related equipment-Specification for extracorporeal circuits for use with haemodialysers, haemofilters and haemoconcentrators
BS EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
BS EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches
BS EN ISO 3826-3:2007 Plastics collapsible containers for human blood and blood components - Blood bag systems with integrated features
BS ISO 8637-1:2024 Extracorporeal systems for blood purification - Plasmafilters
BS ISO 3826-3:2006 Plastics collapsible containers for human blood and blood components - Blood bag systems with integrated features
BS ISO 8637-3:2024 Extracorporeal systems for blood purification - Plasmafilters
BS ISO 16603:2004 Clothing for protection against contact with blood and body fluids - Determination of the resistance of protective clothing materials to penetration by blood and body fluids - Test method using synthetic blood
BS EN ISO 3826-3:2006 Plastics collapsible containers for human blood and blood components. Blood bag systems with integrated features
BS EN ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components. Conventional containers
BS EN 12022:1999 Blood-gas exchangers
BS EN ISO 3826-1:2003 Plastics collapsible containers for human blood and blood components-Conventional containers

Danish Standards Foundation

DANSK DS/ISO 8637-2:2024 Extracorporeal systems for blood purification – Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
DANSK DS/ISO 8637-1:2024 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
DANSK DS/EN ISO 8637-1:2021 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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
DANSK DS/EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems – Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
DANSK DS/EN ISO 8637-2:2018 Extracorporeal systems for blood purification – Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
DANSK DS/EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems – Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
DS/ISO 16603:2005 Clothing for protection against contact with blood and body fluids - Determination of the resistance of protective clothing materials to penetration by blood and body fluids - Test method using synthetic blood
DS/EN 60601-2-16/Corr.:2000 Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
DANSK DS/ISO 16603:2005 Clothing for protection against contact with blood and body fluids - Determination of the resistance of protective clothing materials to penetration by blood and body fluids - Test method using synthetic blood

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
CSN 70 5225-1965 Blood sedimentation pipette, straight
CSN 70 5223-1965 Pipette for red blood corpuscles
CSN 70 5224-1965 Pipette for white blood corpuscles

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)
EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers@ haemodiafilters and haemofilters
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 8637-2 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/DIS 8637-2:2022)
EN ISO 8637-2:2024 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)
EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
EN ISO 3826-1:2003 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers ISO 3826-1:2003
EN 12022:1999 Blood Gas Exchangers

German Institute for Standardization

DIN EN ISO 8637-2:2024-09 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)
DIN EN ISO 8637-1:2020-10 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017); German version EN ISO 8637-1:2020
DIN EN 1283:1996 Hemodialyzers, hemodiafilters, hemofilters, hemoconcentrators and associated LJ blood tubing systems
DIN EN ISO 8637-2:2024 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)
DIN EN ISO 8637-2:2023-01 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/DIS 8637-2:2022); German and English version prEN ISO 8637-2:2022 / Note: Date...
DIN EN ISO 8637-2:2018-12 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 1283:1996-06 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
DIN EN ISO 8637-1 E:2016-05 Extracorporeal systems for blood purification Part 1: Hemodialyzers, hemodialysis filters, hemofilters and hemoconcentrators (draft)
DIN EN ISO 8637 E:2013-06 Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodialysis filters, hemofilters and hemoconcentrators (draft)
DIN 12750:1969 Blood dilution pipettes for blood corpuscles counting
DIN 58934-1:1997 Haematology - Control material for the CBC - Part 1: Control bloods
DIN EN ISO 8637-2 E:2016-05 Extracorporeal systems for blood purification Part 2: Extracorporeal blood circuits for hemodialyzers, hemodiafilters and hemofilters (draft)
DIN EN ISO 8637-1 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 58931:1995-02 Haematology - Determination of haemoglobin concentration in blood - Reference method
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 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
DIN 58931:2021 Haematology - Determination of haemoglobin concentration in blood - Reference method; Text in German and English
DIN 58931:2021-09 Haematology - Determination of haemoglobin concentration in blood - Reference method; Text in German and English
DIN 58931:1995 Haematology - Determination of haemoglobin concentration in blood - Reference method
DIN 58931 E:2009-03 Haematology - Determination of haemoglobin concentration in blood - Reference method
DIN 58931 E:2021-02 Haematology - Determination of haemoglobin concentration in blood - Reference method
DIN EN ISO 8637-2 E:2023-01 Extracorporeal systems for blood purification Part 2: Extracorporeal blood circuits for hemodialyzers, hemodiafilters and hemofilters (draft)
DIN EN ISO 8637 E:2013 Draft Document - Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010); German version FprEN ISO 8637:2013
DIN EN ISO 8638:2014-03 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
DIN EN ISO 8638 E:2013 Draft Document - Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010); German version FprEN ISO 8638:2013
DIN EN ISO 8638 E:2013-06 Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodiafilters and hemofilters for extracorporeal circulation (draft)
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 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 12750:1969-02 Blood dilution pipettes for blood corpuscles counting
DIN 58932-3 E:2016-01 Haematology - Determination of the concentration of blood corpuscles in blood - Part 3: Reference method for the determination of the concentration of erythrozytes
DIN 58931:2021-02 Draft Document - Haematology - Determination of haemoglobin concentration in blood - Reference method; Text in German and English
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
DIN 58934-1:1997-12 Haematology - Control material for the CBC - Part 1: Control bloods
DIN 58932-3:1994 Haematology; determination of the concentration of blood corpuscles in blood; determination of the concentration of erythrocytes; reference method
DIN 58903:2020-04 Haemostaseology - Deficient plasma - Requirements, preparation; Text in German and English
DIN EN ISO 8637:2014-03 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1:2013-04-01)
DIN EN ISO 7199 E:2015-06 Cardiovascular Implants and Artificial Organs Blood Oxygen Exchangers (Oxygenators) (Draft)
DIN 58903:2020 Haemostaseology - Deficient plasma - Requirements, preparation; Text in German and English
DIN EN ISO 7199 E:2014-02 Cardiovascular Implants and Artificial Organs Blood Oxygen Exchangers (Oxygenators) (Draft)
DIN 58932-1:1996-12 Haematology - Determination of the concentration of blood corpuscles in blood - Part 1: Blood collection, sample preparation, biological influence factors, interference factors
DIN 58932-1 E:2010 Draft Document - Haematology - Determination of the concentration of blood corpuscles in blood - Part 1: Blood collection, sample preparation, biological influence factors, interference factors
DIN 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 58932-5:2007-10 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 EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018); German version EN ISO 8637-2:2018
DIN 58932-3:1994-04 Haematology; determination of the concentration of blood corpuscles in blood; determination of the concentration of erythrocytes; reference method
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 58931:2010 Haematology - Determination of haemoglobin concentration in blood - Reference method; Text in German and English
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 58932-1 E:2010-01 Haematology - Determination of the concentration of blood corpuscles in blood - Part 1: Blood collection, sample preparation, biological influence factors, interference factors
DIN 58932-1:2023 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 58931:2010-08 Haematology - Determination of haemoglobin concentration in blood - Reference method; Text in German and English
DIN 58903 E:2019 Draft Document - Haemostaseology - Deficient plasma - Requirements, preparation; Text in German and English
DIN 58932-3:2017 Haematology - Determination of the concentration of blood corpuscles in blood - Part 3: Reference method for the determination of the concentration of erythrozytes; Text in German and English
DIN EN ISO 8637:2014 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 58987:2023-04 Haemostaseology - Reference method for the Von Willebrand Factor antigen; Text in German and English / Note: Date of issue 2023-03-03*Intended as replacement for DIN 58987 (2010-03).
DIN 58987:2024-04 Haemostaseology - Reference method for the Von Willebrand Factor antigen; Text in German and English
DIN EN ISO 7198 E:2014-10 Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches (Draft)
DIN 58988:2024-04 Haemostaseology - Reference method for the Von Willebrand Factor multimers; 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 58905-1:2000-03 Haemostaseology - Blood collection - Part 1: Preparation of plasma from citrated venous blood for coagulation testing

IN-BIS

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

Bureau of Indian Standards

IS/ISO 8637-1-2017 Extracorporeal Systems for Blood Purification Part 1 Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators
IS/ISO 8637-2-2018 Extracorporeal Systems for Blood Purification Part 2 Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters
IS/ISO 8637-2010 Cardiovascular Implants and Extracorporeal Systems - Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators ( First Revision )
IS/ISO 8638-2010 Cardiovascular Implants and Extracorporeal Systems - Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters ( First Revision )
IS 15102-2002 Plastics Collapsible Containers for Human Blood and Blood Components
IS/ISO 3826-4-2015 Plastics Collapsible Containers for Human Blood and Blood Components Part 4 Aphaeresis Blood Bag Systems with Integrated Features
IS/ISO 7198-2016 Cardiovascular Implants and Extracorporeal Systems —— Vascular Prostheses —— Tubular Vascular Grafts and Vascular Patches

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 8637-1:2017 Extracorporeal systems for blood purification— Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ANSI/AAMI/ISO 8637-2:2018 Extracorporeal systems for blood purification— Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ANSI/AAMI RD52-2004(2010) Dialysate for hemodialysis
ANSI/AAMI/ISO 8638:2010(2015) Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ANSI/AAMI/ISO 8637AMD 1:2012 Hemodialyzers, haemodiafilters, haemofilters and haemoconcentrators - Amendment 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports
ANSI/AAMI/ISO 7198:2016 Cardiovascular implants and extracorporeal systems— Vascular prostheses—Tubular vascular grafts and vascular patches
ANSI/AAMI RD5-2003(2008) Hemodialysis systems

RO-ASRO

STAS 11327/9-1983 RUBBER STOPPERS FOR BLOOD, PLASMA AND SOLUTION BOTTLES FOR INJECTIONS AND PERFUSIONS Organic substances determination
STAS 11326/6-1985 RUBBER STOPPERS FOR BLOOD, PLASMA AND A QUEOUS SOLUTION BOTTLES FOR INJECTIONS AND PERFUSIONS Inocuity checking up
STAS 11326/3-1984 RUBBER STOPPERS FOR INJECTABLE AND PERFUSABLE BLOOD, PLASMA AND AQUEOUS SOLUTION BOTTLES Toxicity checking up
STAS 5442-1987 RUBBER STOPPERS FOR BLOOD, PLASMA AND AQUEOUS PERFUSABLE SOLUTION VIALS
STAS 11327/3-1983 RUBBER STOPPERS FOR BLOOD,PLASMA AND SOLUTION BOTTLES FOR INJECTIONS AND PERFUSIONS pH aqueous extract checking out

Association for the Advancement of Medical Instrumentation

AAMI RD16:2007 Cardiovascular implants and artificial organs - Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ANSI/AAMI RD16-2007 Cardiovascular implants and artificial organs-Hemodialyzers,hemodiafilters,hemofilters,and hemoconcentrators
ANSI/AAMI RD17-2007 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
AAMI 8637-2010-A1-2013- Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
AAMI RD61:2006 Concentrates for hemodialysis
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
AAMI RD5:2003(R2008) Hemodialysis Systems

GCC Standardization Organization

GSO ISO 8637:2016 Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
GSO ISO 8638:2016 Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
GSO ISO 16603:2013 Clothing for protection against contact with blood and body fluids -- Determination of the resistance of protective clothing materials to penetration by blood and body fluids -- Test method using synthetic blood

Standards Norway

NS-EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
NS-EN ISO 8637-1:2020 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
NS-EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
NS-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
NS-EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)

The Directorate General of Specifications and Metrology (DGSM)

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

Lithuanian Standards Office

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

Swedish Institute for Standards

SS-EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
SS-EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
SS-EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
SS-EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)

Kingdom of Bahrain Testing and Metrology Directorate

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

Indonesia Standards

SNI ISO 8638:2012 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
SNI 16-4774-1998 Transfusion equipment for medical use - Blood taking set

Defense Logistics Agency

DLA NNN-B-300 A-1977 BLOOD COLLECTING-CULTURE UNIT, LABORATORY

Austrian Standards

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

Standard Association of Australia （SAA）

AS 3864:1991 Medical refrigeration equipment - For the storage of blood and blood products, and containers for the transport of blood and blood products
AS 3207:1981 Approval and test specification for haemodialysis machines
AS 3864:1997 Medical refrigeration equipment - For the storage of blood and blood products
AS 3864:1997/Amdt 1:1998 Medical refrigeration equipment - for storing blood and blood products
AS 3864.1:2012 Medical refrigeration equipment for storage of blood and blood products manufacturing requirements

SE-SIS

SIS SS 87 511 06-1989 Infusion sets for blood

American Society for Testing and Materials (ASTM)

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

South African Bureau of Standard

TR 51-03 Standards of Practice for Blood Services in South Africa - Blood Donor Selection & Blood Collection
TR 39-02 Standards of Practice for Blood Services in South Africa - Compatibility Testing and Transfusion of Blood Products
TR 40-02 Standards of Practice for Blood Services in South Africa - Blood Product Specifications
TR 37-01 Standards of Practice for Blood Services in South Africa - Testing and Disposition of Blood Products
TR 38-02 Standards of Practice for Blood Services in South Africa - Processing of Blood Products

YU-JUS

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

Magyar Szabványügyi Testület

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

Thai Industrial Standards Institute (TISI)

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

COMMISSION FOR THE STANDARDS, METROLOGY AND QUALITY OF VIETNAM (STAMEQ)

TCVN 7611-2007 Plastics collapsible containers for human blood and blood components
TCVN 7303-2-16-2007 Medical electrical equipment.Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

Association for Electrical, Electronic & Information Technologies (VDE)

VDE 0750-206 DIN VDE 0750-206-1984*DIN 57750-206:1984 Medical electrical equipment - Haemodialysis equipment - Particular requirements for safety

North Atlantic Treaty Organization Standards Agency

AMEDP-12-1998 NATO BLOOD BROCHURE
AMEDP-12(A)-2003 NATO BLOOD BROCHURE