dialysis bag dialysis polysaccharide

dialysis bag dialysis polysaccharide, Total:286 items.

The international standard classification for "dialysis bag dialysis polysaccharide" includes: Surgical instruments and materials , Implants for surgery, prosthetics and orthotics , Other medical equipment , Medical equipment , Physicochemical methods of analysis , Transfusion, infusion and injection equipment , Glass .

The Chinese standard classification for "dialysis bag dialysis polysaccharide" includes: Extracorporeal circulation, artificial organ and prosthesis device , Medical sanitary products , Sanitation in general , Basic standards and general methods , Quartz glass .

Group Standards of the People's Republic of China

T/CNPPA 3002―2018 Technical guidelines for peritoneal dialysis fluid packaging systems
T/GDACM 0128-2024 Technical specification for chronic disease management with Chinese Medicine — peritoneal dialysis
T/CSBME 029-2021 Quality control guidelines for peritoneal dialysis equipment in using
T/CNMIA 0002-2019 Evaluation criteria for independent hemodialysis centers
T/SSPI 001-2021 Polyvinyl chloride film for the collection of waste fluid for peritoneal dialysis(PD) bags
T/NBPIA 011-2023 Classification of peritoneal dialysis solution
T/ZZB 1290-2019 Medical dialysis base paper
T/NBPIA 002-2020 Technical Specification for quality of dialysate and online hemodialysis replacement fluid
T/CNPPA 3002-2018 Technical guildance for the container closure system of peritoneal dialysis solution
T/CAME 46-2022 Essential requirements for engineering technical personnel of hemodialysis
T/CAME 48-2022 Centre concentrate delivery system for haemodialysis
T/SHNA 0006-2023 Hemodialysis extracorporeal circulation priming operating procedures
T/NBPIA 003-2020 Technical Specification for quality of hemodialysis water
T/NBPIA 010-2023 Clinical Practice Guidelines for Home Hemodialysis
T/CAMDI 103-2023 Hemodialysis IV catheter for single use
T/NBPIA 007-2021 Classification of hemodialyzer clinical performance

Professional Standard - Medicine

YY 0598-2015(A1) Concentrates for haemodialysis and related therapies
YY 0793.2-2011 Technical requirements of water treatment equipments for haemodialysis applications and related therapies—Part 2:For single-bed haemodialysis
YY 0054-2010 Haemodialysis equipment
YY 0053-1991 Hollow fiber dialyzer
YY/T 1272-2016 Dialysis fluid filter
YY 0053-2008 Cardiovascular implants and artificial organs—Haemodialysers haemodiafilters haemofilters and haemoconcentrators
YY/T 0030-2004 Peritoneal dialysis catheters
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 1545-2017 Evaluation of connection between haemodialysis concentrate and haemodialysis equipment
YY/T 1274-2016 Pressure control peritoneal dialysis equipment
YY 0598-2015 Concentrates for haemodialysis and related therapies
YY 0054-2003 Haemodialysis、haemodiafiltration and haemofiltration equipment
YY 0572-2005 Water for haemodialysis and related therapies
YY 0572-2015 Water for haemodialysis and related therapies
YY 1274-2016 Pressure control peritoneal dialysis equipment
YY 0030-2004 Peritoneal dialysis catheters
YY/T 0598-2015 Concentrates for haemodialysis and related therapies
YY 0053-2016 Hemodialysis and relavant therapics -Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
YY 1493-2016 Gravity control peritoneal dialysis equipment
YY/T 1920-2023 Blood compatibility tests of haemodialysers
YY 0598-2006 Concentrates for haemodialysis and related therapies
YY 1272-2016 Dialysis fluid filter
YY 0793.1-2010 Technical requirements of water treatment equipments for haemodialysis applications and related therapies—Part 1:For multi-beds haemodialysis
YY/T 1493-2016 Gravity control peritoneal dialysis equipment

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
CSA Z23500-3-2020 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
DIN EN ISO 11663 E:2015-05 Quality of dialysate for hemodialysis and related treatments (draft)
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
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
DIN EN ISO 13959 E:2015-04 Water for hemodialysis and related treatments (draft)
CSA Z364.5-2017 Safety of installation and operation of hemodialysis and home peritoneal dialysis
CSA Z364.6-2017 Quality Management for Renal Dialysis Providers
ANSI/AAMI/ISO 8637-1:2017 Extracorporeal systems for blood purification— Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
DIN EN 1283:1996 Hemodialyzers, hemodiafilters, hemofilters, hemoconcentrators and associated LJ blood tubing systems
DIN EN ISO 8637 E:2013-06 Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodialysis filters, hemofilters and hemoconcentrators (draft)

Jilin Provincial Standard of the People's Republic of China

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

国家药监局

YY/T 1760-2021 Disposable drainage system for peritoneal dialysis
YY/T 1773-2021 Disposable transfer line for peritoneal dialysis
YY/T 1730-2020 Hemodialysis catheter for single use
YY/T 1761-2021 Disinfectant for dialysis machine dialysate circuit
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 1734-2020 Iodine liquid protective cap for peritoneal dialysis
YY 0054-2023 Haemodialysis equipment

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

JJF 1353-2012 Calibeation Specification for Hemodialysis Equipment
JJF 1541-2015 Calibration Specification for Hemodialysis Equipment Tester

工业和信息化部

YB/T 4676-2018 Analysis of precipitates of steel-Transmission election microscope method

Professional Standard - Agriculture

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
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

Professional Standard - Education

JY/T 0581-2020 General analysis rules for transmission electron microscope

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

GB 9706.2-2003 Medical electrical equipment—Part 2-16:Particular requirements for the safety of haemodialysis,haemodiafiltration and haemofiltration equipment
GB/T 18907-2013 Microbeam analysis—Analytical electron microscopy—Selected-area electron diffraction analysis using a transmission electron microscope

Professional Standard - Building Materials

JC/T 750-2014 Test method for anti-devitrification of transparent quartz glass

SCC

AAMI RD52:2004 Dialysate for Hemodialysis (Includes A1:2007 and A2:2007)
ISO/DIS 13959:1997 Water for Haemodialysis or Haemodiafiltration - Requirements
CAN/CSA-ISO 11663-11:2011 Quality of dialysis fluid for haemodialysis and related therapies
DANSK DS/EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies
AAMI/ISO 11663:2009 Quality of dialysis fluid for hemodialysis and related therapies
AAMI 11663:2014 Quality of dialysis fluid for hemodialysis and related therapies
ISO/DIS 13958:1997 Concentrates for Haemodialysis or Haemodiafiltration
AAMI TIR43:2011 Ultrapure dialysate for hemodialysis and related therapies
AAMI TIR43:2021 Ultrapure dialysis fluid for hemodialysis and related therapies
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
AAMI RD5:2003(R2008) Hemodialysis Systems
CSA Z364.5-2022 Safety of installation and operation of hemodialysis and home peritoneal dialysis
AENOR UNE-EN ISO 11663:2016 Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
NS-EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
AAMI TIR72:2017 Dialysis fluid chemical composition
AAMI RD61:2006 Concentrates for hemodialysis
CSA Z364.5-2010(R2015) Safe installation and operation of hemodialysis and peritoneal dialysis in a home setting
DIN EN ISO 11663 E:2015 Draft Document - Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014); German and English version FprEN ISO 11663:2015
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
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
AAMI RD47:2020 Reprocessing of hemodialyzers
CAN/CSA-ISO 11663-2015 Quality of dialysis fluid for haemodialysis and related therapies (Adopted ISO 11663:2014, second edition, 2014-04-01)
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)
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
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)
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)
UNE-EN 1283:1996 HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS.
NS-EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
BS 7297-1:1990 Haemodialysers and related equipment-Specification for haemodialysers, haemofilters and haemoconcentrators
CSA Z364.6-2023 Quality Management for Renal Dialysis Providers
CSA Z364.2.1-1994(R2011) Fluid Supply and Monitoring Systems for Haemodialysis
CSA Z364.2.1-M1986-1986 Fluid Supply and Monitoring Systems for Hemodialysis
AAMI 13959:2014 Water for hemodialysis and related therapies
AAMI/ISO 13959:2009 Water for hemodialysis and related therapies
CAN/CSA-ISO 13959-11:2011 Water for haemodialysis and related therapies
CSA Z364.6-2017(R2022) Quality management for kidney dialysis providers
DANSK DS/EN ISO 13959:2015 Water for haemodialysis and related therapies
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...
AWWA MTC69659 Low Pressure Reverse Osmosis and Donnan Dialysis for Simultaneous Removal of Nitrate and Perchlorate
AS 3207:1981 Approval and test specification for haemodialysis machines
AAMI RD16:2007 Cardiovascular implants and artificial organs - Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
DANSK DS/EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems – Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
CSA Z364.2.2-1994 Water Treatment Equipment and Water Quality Requirements for Haemodialysis
13/30270471 DC BS ISO 13959. Water for haemodialysis and related therapies
AAMI RD62:2006 Water treatment equipment for hemodialysis applications
NS-EN ISO 13959:2015 Water for haemodialysis and related therapies (ISO 13959:2014)
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
08/30179598 DC BS ISO 13959. Water for haemodialysis and related therapies
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
CSA Z364.2.2-1994(R1999) Water Treatment Equipment and Water Quality Requirements for Haemodialysis
CSA Z364.2.2-2003(R2008) Water Treatment Equipment and Water Quality Requirements for Hemodialysis
AAMI/ISO 8637-1:2017 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
AAMI/ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 3: Water for haemodialysis and related therapies
AENOR UNE-EN 60601-2-16 CORR:2000 Electromedical equipment - Part 2-16: Particular requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration equipment.
BS 7297-2:1990 Haemodialysers and related equipment-Specification for extracorporeal circuits for use with haemodialysers, haemofilters and haemoconcentrators
DANSK DS/EN ISO 8637-1:2021 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
AENOR UNE-EN 60601-2-16:1999 Electromedical equipment. Part 2-16: Particular requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration equipment.

US-FCR

FCR FED H-08-9 CHAP 316-1981 DIALYSIS CENTER
FCR FED H-08-4 VOL 3 SEC I 376-1988 DETAIL - DIALYSIS BOX
FCR FED H-08-5 CHAP 316 TRANSMITTAL NO.186-1988 DIALYSIS CENTER, TRANSMITTAL NO. 186

International Organization for Standardization (ISO)

ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies
ISO/DIS 23500-5 Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ISO/FDIS 23500-5:2011 Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ISO 13959:2002 Water for haemodialysis and related therapies
ISO 13959:2009 Water for haemodialysis and related therapies
ISO 13959:2014 Water for haemodialysis and related therapies
ISO 13958:2014 Concentrates for haemodialysis and related therapies
ISO 13958:2009 Concentrates for haemodialysis and related therapies
ISO 13958:2002 Concentrates for haemodialysis and related therapies
ISO 8637:2010 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637:2004 Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO/DIS 23500-3 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water 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/DIS 8637-1 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO/FDIS 8637-1:2023 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO/CD 8637-1 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO/DIS 23500-4 Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
ISO 8638:2004 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ISO 8637-1:2024 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8638:2010 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
IEC TR 62653:2012 Guidelines for the safe use of medical products in dialysis treatment

Korean Agency for Technology and Standards (KATS)

KS P ISO 11663-2022 Quality of dialysis fluid for haemodialysis and related therapies
KS P ISO 13959-2021 Water for haemodialysis and related therapies
KS P ISO 13959:2009 Water for haemodialysis and related therapies
KS P ISO 13959-2009(2019) Water for haemodialysis and related therapies
KS C IEC 60601-2-16:2002 Haemodialysis, haemodiafiltration and haemofiltration equipment
KS P ISO 13958:2009 Concentrates for haemodialysis and related therapies
KS P ISO 13958-2009(2019) Concentrates for haemodialysis and related therapies
KS P ISO 8637-2023 Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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 8637-1-2023 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
KS P ISO 8638-2022 Cardiovascular implants and extracorporeal systems －Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 11663(Ed1):2009 Quality of dialysis fluid for haemodialysis and related therapies
ANSI/AAMI/ISO 11663:2009 Quality of dialysis fluid for haemodialysis and related therapies
ANSI/AAMI/ISO 13959:2009 Water for hemodialysis and related therapies
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 13958:2009 Concentrates for hemodialysis and related therapies
ANSI/AAMI RD47:2002/A1-2003 Reuse of Hemodialyzers Amendment 1
ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

Indonesia Standards

SNI ISO 11663:2011 Quality of dialysate solutions for hemodialysis and similar treatments
SNI ISO 13959:2010 Water for haemodialysis and related therapies
SNI ISO 8638:2012 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

US-AAMI

ANSI/AAMI 11663-2014 Quality of dialysis fluid for haemodialysis and related therapies
ANSI/AAMI 13959-2014 Water for hemodialysis and related therapies
AAMI RD62-2006 Water treatment equipment for hemodialysis application
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/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 RD17-2007 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters

British Standards Institution (BSI)

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
BS ISO 11663:2009 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 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies. Quality of dialysis fluid 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
BS ISO 13959:2009 Water for haemodialysis and related therapies
BS ISO 13959:2014 Water for haemodialysis and related therapies
BS EN ISO 13959:2015 Water 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 EN ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies. Water for haemodialysis and related therapies
BS EN ISO 13958:2015 Concentrates for haemodialysis and related therapies
BS EN 13867:2002 Concentrates for haemodialysis and related therapies
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 13867:2002+A1:2009 Concentrates for haemodialysis and related therapies
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

GSO

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
BH GSO ISO 13959:2017 Water for haemodialysis and related therapies
GSO ISO 13959:2015 Water for haemodialysis and related therapies
GSO IEC/TR 62653:2015 Guideline for safe operation of medical equipment used for haemodialysis treatments
GSO ISO 8637:2016 Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
BH GSO ISO 8637:2017 Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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
BH GSO ISO 8638:2017 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

KR-KS

KS P ISO 11663-2017 Quality of dialysis fluid for haemodialysis and related therapies
KS P ISO 23500-5-2022 Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
KS P ISO 23500-3-2021 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies

Canadian Standards Association (CSA)

CAN/CSA-ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies (Second Edition)
CSA Z364.5-2010 Safe installation and operation of hemodialysis and peritoneal dialysis in a home setting (First Edition)
CSA Z364.2.1-2013 Monitoring systems for hemodialysis equipment (Third Edition)
CSA Z8637-08-CAN/CSA-2008 Cardiovascular implants and artificial organs ?Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
CAN/CSA-ISO 13959:2011 Eau pour hémodialyse et thérapies apparentées (Première Édition)
CAN/CSA-ISO 13959:2015 Water for haemodialysis and related therapies (Second Edition)

CZ-CSN

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

Aerospace Industries Association/ANSI Aerospace Standards

AIA/NAS NAS3403-2013 BAG, TRANSPARENT, MULTIPLE ITEM (Rev 3)
AIA/NAS NAS3402-2013 BAG, TRANSPARENT, SINGLE ITEM (Rev 3)

Aerospace Industries Association

AIA NAS 3403-1983 Bag, Transparent, Multiple Item (Rev. 2)
AIA NAS 3402-1983 Bag, Transparent, Single Item (Rev. 2)
AIA NAS 3435-1983 (Inactive)Box, with Multiple Individual Transparent Bags (Rev. 2)
AIA NAS 3418-1983 Bag, Opaque, Single Item (Rev. 2)
AIA NAS 3405-1983 Bag, Transparent, Single Item, with Accessories (Rev. 2)

Standard Association of Australia （SAA）

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

US-GSA

GSA A-A-2748 A-1992 ENVELOPE, TRANSLUCENT

RU-GOST R

GOST R 52556-2006 Water for hemodialysis. Specifications
GOST R ISO 13958-2015 Concentrates for haemodialysis and related therapies
GOST 21472-1981 Sheel materials. Gravimetric method for determining steam permeability

Japanese Industrial Standards Committee (JISC)

JIS T 3250:2022 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

European Committee for Standardization (CEN)

EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies
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)
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)
EN ISO 13959:2015 Water for haemodialysis and related therapies

German Institute for Standardization

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 11663:2016 Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014); German version EN ISO 11663:2015
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 23500-5:2017 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 13959:2016 Water for haemodialysis and related therapies (ISO 13959:2014)
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 23500-3:2019-11 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...

CEN - European Committee for Standardization

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 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies

Association Francaise de Normalisation

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 S93-301:2009 Concentrates for haemodialysis and related therapies.
NF S93-301/IN1:2009 Concentrates for haemodialysis and related therapies.
NF S93-302*NF EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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 S93-315:2008 Fluids for hemodialysis - Requirements and user recommendations
NF EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
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 S93-303:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

ES-UNE

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

AENOR

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.

HU-MSZT

MNOSZ 24141-1955 Transparent crystal calcium. Analysis purpose

AIA/NAS - Aerospace Industries Association of America Inc.

NAS3435-1983 Box@ with Multiple Individual Transparent Bags (Rev 2)
NAS3435-2012 BOX@ WITH MULTIPLE INDIVIDUAL TRANSPARENT BAGS (Rev 3)
NAS3436-2012 BOX@ WITH TRANSPARENT BAG@ CYLINDRICAL CORE (Rev 3)
NAS3418-1983 Bag@ Opaque@ Single Item (Rev 2)

PT-IPQ

E 239-1970 Soil, moisture penetrating particle analysis

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

AT-ON

ONORM EN 1283-1996 Haemodialysers,haemodiafilters,haemofilters,haemoconcentrators and their extracorporeal circuits
ONORM L 1070-1988 Physical analysis of soils; determination of air permeability of soils

American Society for Testing and Materials (ASTM)

ASTM D4195-88(2003) Standard Guide for Water Analysis for Reverse Osmosis Application
ASTM D4195-88(1998)e1 Standard Guide for Water Analysis for Reverse Osmosis Application

BR-ABNT

ABNT MB-123R-1953 sugar analysis

RO-ASRO

SR 110-1-1944 Sugar. Methods of analysis. Sensorial analysis

American Society of Mechanical Engineers (ASME)

ASME SEC XI D3 NMA APP A-2001 Appendix A Analysis of Flaw Indications In The Course of Preparation

VN-TCVN

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

BSI

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

Others: