hemodialysis membrane

hemodialysis membrane, Total:197 items.

The international standard classification for "hemodialysis membrane" includes: Surgical instruments and materials , Implants for surgery, prosthetics and orthotics , Transfusion, infusion and injection equipment , Hospital equipment , Test conditions and procedures in general .

The Chinese standard classification for "hemodialysis membrane" includes: Extracorporeal circulation, artificial organ and prosthesis device , General and microsurgical devices , Medical sanitary products , Sanitation in general , Medical laboratory equipment , Separating machinery .

Professional Standard - Medicine

YY/T 1920-2023 Blood compatibility tests of haemodialysers
YY/T 1545-2017 Evaluation of connection between haemodialysis concentrate and haemodialysis equipment
YY 0053-2008 Cardiovascular implants and artificial organs—Haemodialysers haemodiafilters haemofilters and haemoconcentrators
YY 0054-2003 Haemodialysis、haemodiafiltration and haemofiltration equipment
YY 0267-2016 Hemodialysis and related therapies―Extracorporeal blood circuit for blood purification devices
YY 0054-2010 Haemodialysis equipment
YY/T 1286.1-2015 Platelets storage container performances―Part 1:Determination of gas permeability of the film―Differential-pressure method
YY/T 0030-2004 Peritoneal dialysis catheters
YY 0053-2016 Hemodialysis and relavant therapics -Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
YY 0030-2004 Peritoneal dialysis catheters

Taiwan Provincial Standard of the People's Republic of China

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

未注明发布机构

ANSI/AAMI/ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies—Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ANSI/AAMI/ISO 8637-2:2018 Extracorporeal systems for blood purification— Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
DIN EN ISO 8637 E:2013-06 Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodialysis filters, hemofilters and hemoconcentrators (draft)
ANSI/AAMI/ISO 8638:2010(2015) Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
DIN EN 1283:1996 Hemodialyzers, hemodiafilters, hemofilters, hemoconcentrators and associated LJ blood tubing systems
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 8637-2 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:2016-05 Extracorporeal systems for blood purification Part 1: Hemodialyzers, hemodialysis filters, hemofilters and hemoconcentrators (draft)
DIN EN ISO 8638 E:2013-06 Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodiafilters and hemofilters for extracorporeal circulation (draft)
ANSI/AAMI/ISO 8637-1:2017 Extracorporeal systems for blood purification— Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
CSA ISO 8637-2:2021 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

Professional Standard - Agriculture

548药典化学药和生物制品卷-2010 Chapter 7 Drugs for the Urinary System Section 2 Blood Purification Dialysate and Replacement Fluid Peritoneal Dialysate

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

国家药监局

YY 0054-2023 Haemodialysis equipment

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

GB/T 13074-1991 Terms of blood purification Hemodialysis and hemofiltration
GB 9706.2-1991 Medical electrical equipment--Particular requirements for safety of haemodialysis equipment
GB 9706.2-2003 Medical electrical equipment—Part 2-16:Particular requirements for the safety of haemodialysis,haemodiafiltration and haemofiltration equipment

工业和信息化部

HG/T 4870-2015 One way vision

Professional Standard - Military and Civilian Products

WJ 2119-1993 Transparent Conductive Film Specifications

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

JJF 1353-2012 Calibeation Specification for Hemodialysis Equipment

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 34243-2017 Test method for pervaporation dehydration membranes

SCC

CSA Z364.5-2022 Safety of installation and operation of hemodialysis and home peritoneal dialysis
CSA Z364.5-2010(R2015) Safe installation and operation of hemodialysis and peritoneal dialysis in a home setting
ISO/DIS 13959:1997 Water for Haemodialysis or Haemodiafiltration - Requirements
UNE-EN 1283:1996 HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS.
NS-EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
ISO/DIS 13958:1997 Concentrates for Haemodialysis or Haemodiafiltration
AAMI RD16:2007 Cardiovascular implants and artificial organs - Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
CAN/CSA Z364.1.1/Z364.1.2-1994(R2006) Haemodialysers, Haemofilters and Haemoconcentrators/ Extracorporeal Blood Circuit for Haemodialysers, Haemofilters and Haemoconcentrators
BS 7297-1:1990 Haemodialysers and related equipment-Specification for haemodialysers, haemofilters and haemoconcentrators
DANSK DS/EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems – Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
DANSK DS/EN ISO 8637-1:2021 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
AAMI RD5:2003(R2008) Hemodialysis Systems
CAN/CSA-Z364.1.1-1994(C2006) Hemodialyzers, hemofilters and hemoconcentrators
CAN 3-Z364.1.1-M84-1984 Hemodialyzers, hemofilters and hemoconcentrators
CAN/CSA-Z364.1.1-1994(R2006) Haemodialysers, Haemofilters and Haemoconcentrators
AAMI/ISO 8637-1:2017 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
AAMI RD61:2006 Concentrates for hemodialysis
AAMI/ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
AAMI/ISO RD17:2007 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
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)
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
BS 7297-2:1990 Haemodialysers and related equipment-Specification for extracorporeal circuits for use with haemodialysers, haemofilters and haemoconcentrators
DANSK DS/EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems – Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
CAN/CSA-Z364.1.2-1994(R2006) Extracorporeal Blood Circuit for Haemodialysers, Haemofilters and Haemoconcentrators
AENOR UNE-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
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)
NS-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
NS-EN ISO 8637-2:2018 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)
AAMI RD52:2004 Dialysate for Hemodialysis (Includes A1:2007 and A2:2007)
AAMI RD47:2020 Reprocessing of hemodialyzers
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 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 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
CAN/CSA-Z364.1.2-1994(C2006) Extracorporeal blood circuit for hemodialyzers, hemofilters and hemoconcentrators
CAN/CSA-ISO 11663-11:2011 Quality of dialysis fluid for haemodialysis and related therapies
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)
AAMI 11663:2014 Quality of dialysis fluid for hemodialysis and related therapies
AAMI/ISO 11663:2009 Quality of dialysis fluid for hemodialysis and related therapies
DANSK DS/EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies
AWWA MTC57570 Fouling Resistant Reverse Osmosis Membranes
CAN/CSA-C22.2 No.60601-2-16-2001(R2005) Medical Electrical Equipment - Part 2-16: Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment
NS-EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
CAN 3-Z364.1.2-M84-1984 Extracorporeal circuits for hemodialyzers, hemofilters and hemoconcentrators
AWWA MTC95005 Ultra-Low Pressure Reverse Osmosis Membranes
CAN/CSA-Z364.1.3-1998(C2014) Reuse of hemodialyzers
CAN/CSA-Z364.1.3-1998(R2014) Reuse of Haemodialysers
CAN/CSA Z364.1.3-1998(R2014) Reuse of Haemodialysers
AENOR UNE-EN 60601-2-16:1999 Electromedical equipment. Part 2-16: Particular requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration equipment.
AENOR UNE-EN 60601-2-16 CORR:2000 Electromedical equipment - Part 2-16: Particular requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration equipment.

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

CZ-CSN

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

Canadian Standards Association (CSA)

CSA Z364.5-2010 Safe installation and operation of hemodialysis and peritoneal dialysis in a home setting (First Edition)
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)
CAN/CSA-ISO 8637A:2015 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators AMENDMENT 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports (First Edition)
CSA Z8638-08-CAN/CSA-2008 Cardiovascular implants and artificial organs ?Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters First Edition [Replaced: CSA Z364.1.1/Z364.1.2-94, CSA Z364.1.1/Z364.1.2-94]
CSA 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)

Standard Association of Australia （SAA）

AS/NZS 3200.2.16:1999 Medical electrical equipment - Particular requirements for safety - Haemodialysis, haemodiafiltration and haemofiltration equipment

ES-AENOR

UNE 111-325-1989 Hemodialysis, blood filters and blood hubs
UNE 111-301-1990 Characteristics of hemodialysis water
UNE 111-350-1989 Hemodialysis, extracorporeal circulation with blood filters and blood hubs

Lithuanian Standards Office

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

Danish Standards Foundation

DS/EN 1283:1997 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
DS/EN ISO 8637-1:2021 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
DS/EN 60601-2-16/Corr.:2000 Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
DS/EN 60601-2-16:1999 Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

US-AAMI

ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ANSI/AAMI RD16-2007 Cardiovascular implants and artificial organs-Hemodialyzers,hemodiafilters,hemofilters,and hemoconcentrators
ANSI/AAMI RD17-2007 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
ANSI/AAMI/ISO 8637:2010/A1:2013 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators - Amendment 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports
ANSI/AAMI 11663-2014 Quality of dialysis fluid for haemodialysis and related therapies

British Standards Institution (BSI)

BS EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
BS EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
23/30470631 DC BS ISO 8637-1. Extracorporeal systems for blood purification - Part 1. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
BS EN ISO 8637-2:2018 Extracorporeal systems for blood purification. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
BS EN ISO 8637-2:2024 Extracorporeal systems for blood purification - Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
16/30331650 DC BS EN ISO 8637-1. Extracorporeal systems for blood purification. Part 1. 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 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies
BS ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies

International Organization for Standardization (ISO)

ISO 8637:2010 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO/DIS 8637-1 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO/CD 8637-1 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO/FDIS 8637-1:2023 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637:1989 Haemodialysers, haemofilters and haemoconcentrators
ISO 8637:2004 Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 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 8637-1:2017 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637-1:2024 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ISO 8638:1989 Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators
ISO/FDIS 8637-2:2023 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637-2:2024 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies
ISO/DIS 8637-2 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Association Francaise de Normalisation

NF S93-302*NF EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
NF EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
NF S93-303:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
NF EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
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

GSO

OS GSO ISO 8637:2016 Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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
BH GSO ISO 8637:2017 Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
GSO ISO 8638:2016 Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
BH GSO ISO 8638:2017 Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
BH GSO ISO 11663:2022 Quality of dialysis fluid for haemodialysis and related therapies
GSO ISO 11663:2021 Quality of dialysis fluid for haemodialysis and related therapies

German Institute for Standardization

DIN EN ISO 8637-1:2020-10 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017); German version EN ISO 8637-1:2020
DIN EN ISO 8637-2:2018-12 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018); German version EN ISO 8637-2:2018 / Note: To be replaced by DIN EN ISO 8637-2 (2023-01).
DIN EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
DIN EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010); German version EN ISO 8638:2014
DIN EN ISO 8637-2:2023-01 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...

AT-ON

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

ES-UNE

UNE-EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
UNE-EN ISO 8637-2:2019 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)

Korean Agency for Technology and Standards (KATS)

KS P 4907-2013 Haemodialysers, haemofilters and haemoconcentrators
KS P 4907-2011 Haemodialysers, haemofilters and haemoconcentrators
KS P ISO 8637-2023 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P ISO 8637-1-2023 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P ISO 8637:2012 Cardiovascular implants and extracorporeal systems－Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P ISO 8638-2022 Cardiovascular implants and extracorporeal systems －Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
KS C IEC 60601-2-16:2002 Haemodialysis, haemodiafiltration and haemofiltration equipment
KS P ISO 8638:2012 Cardiovascular implants and extracorporeal systems －Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
KS P ISO 8637:2018 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P ISO 11663-2022 Quality of dialysis fluid for haemodialysis and related therapies

Indonesia Standards

SNI ISO 8638:2012 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
SNI ISO 11663:2011 Quality of dialysate solutions for hemodialysis and similar treatments

American National Standards Institute （ANSI)

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 11663:2009 Quality of dialysis fluid for haemodialysis and related therapies
ANSI/AAMI/ISO 11663(Ed1):2009 Quality of dialysis fluid for haemodialysis and related therapies

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 8638:2014 Cardiovascular implants and extracorporeal systems - 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)

BSI

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

IN-BIS

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

CEN - European Committee for Standardization

EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers@ haemodiafilters and haemofilters

KR-KS

KS P ISO 8637-2-2022 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
KS P ISO 8637-2018 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P ISO 11663-2017 Quality of dialysis fluid for haemodialysis and related therapies

AENOR

UNE-EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
UNE 111301:1990 REQUIREMENTS OF WATER USED IN HEMODIALYSIS
UNE-EN 60601-2-16:1999 MEDICAL ELECTRICAL EQUIPMENT. PART 2-16: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT.
UNE-EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)

Military Standards (MIL-STD)

DOD A-A-53391-1988 CUVETTE, BLOOD COAGULATION (POLYSTYRENE, DISPOSABLE)

RU-GOST R

GOST R 52556-2006 Water for hemodialysis. Specifications
GOST R 50267.16-2003 Medical electrical equipment. Part 2. Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
GOST R 50267.16-1993 Medical electrical equipment. Part 2. Particular requirements for safety of haemodialysis equipment
GOST R ISO 8637-1999 Haemodialysers, haemofilters and haemoconcentrators. Technical requirements and test methods

GM North America

GM 9984168-2002 Transit Coating (Film) Revision A [Replaced: HOLDEN HN 1684, HOLDEN HN 1685]

VN-TCVN

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

Others: Portable hemodialysis,semipermeable membrane,hemodialysis,flow permeable membrane,Oxygen permeable membrane,Oxygen permeable membrane,Portable Hemodialysis Apparatus,flow + membrane penetrating agent,Portable hemodialysis