blood test equipment

blood test equipment, Total:199 items.

The international standard classification for "blood test equipment" includes: Surgical instruments and materials , Implants for surgery, prosthetics and orthotics , Laboratory medicine , Transfusion, infusion and injection equipment , Protection against crime , Other medical equipment , Law. Administration , Medical Sciences and health care facilities in general .

The Chinese standard classification for "blood test equipment" includes: Extracorporeal circulation, artificial organ and prosthesis device , Medical optical instrument and endoscope , Medical laboratory equipment , Traffic safety detecting equipment , Crime judging technology , Medical sanitary products , Traffic control in general , Sanitation in general , Legal medical expert .

Professional Standard - Medicine

YY/T 1545-2017 Evaluation of connection between haemodialysis concentrate and haemodialysis equipment
YY 0054-2003 Haemodialysis、haemodiafiltration and haemofiltration equipment
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 1413-2016 Centrifugal blood components separation device
YY 0645-2008 Continuous Blood Purification Equipment
YY 0790-2010 Hemoperfusion equipment
YY 0054-2010 Haemodialysis equipment
YY/T 1414-2016 Liquid line solenoid valve for haemodialysis equipment

国家药监局

YY 0054-2023 Haemodialysis equipment
YY/T 1834-2022 X-ray blood irradiation device
YY/T 0793.1-2022 Preparation and quality management for liquid used in haemodialysis and related therapies—Part 1: Water treatment equipments for haemodialysis and related therapies

Group Standards of the People's Republic of China

T/CSBT 007-2019 Requirements for external quality assessment of blood screening laboratory
T/CSBT 004-2019 Quality monitoring indicators of blood testing laboratory in blood transfusion service
T/CAS 886-2024 Technical specifications for performance verification of transfusion compatibility testing instrument
T/CAME 38-2021 Performance validation of nucleic acid testing in blood screening

国家药品监督管理局

YY 0645-2018 Continuous blood purification equipment

Professional Standard - Public Safety Standards

GA/T 1320-2016 GC-MS examination methods for fluoride ion in urine and blood in forensic science
GA 657-2006 Detection method for ABO blood type in human body fluid stains—Hemagglutination inhibition test
GA/T 2073-2023 Forensic sciences-Examination methods for carboxyhaemoglobin in blood samples-Spectrophotometry
GA/T 1147-2014 Labortory specifications for examination of ethanol concentration in drivers blood
GA/T 1331-2016 LC-MS/MS examination methods for abamectin B1a in blood samples in forensic science
GA/T 1632-2019 Forensic sciences—Examination methods for mepiquat and chlormequat in blood and urine samples—LC-MS
GA/T 842-2009 Analysis method for ethanol concentration in blood
GA/T 842-2019 Examination methods for ethanol concentration in blood
GA 656-2006 Detection method for ABO blood type in human blood(stains)—Hemagglutination test elution test

Professional Standard - Commodity Inspection

SN/T 4352-2015 Inspection and quarantine procedure for feeding blood products
SN/T 0967-2000 Rules for the inspection of once using infusion and transfusion sets for import and export
SN/T 0323.3-2007 Rules for the inspection of medical equipment for import and export - Part 3 : Plastics collapsible containers for human blood-Blood components conventional containers
SN/T 1672.3-2005 Rules for the inspection of medical equipment for import and export--Part 3: Transcranial Doppler blood flow analyzer

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

GB 19522-2010 Blood & breath alcohol concentration and examination for vehicle drivers
GB 19522-2004 Blood-breath alcohol concentration and examination for driving
GB 19522-2024 Blood & breath alcohol concentration and examination for vehicle drivers
GB 9706.2-2003 Medical electrical equipment—Part 2-16:Particular requirements for the safety of haemodialysis,haemodiafiltration and haemofiltration equipment

National Health Commission of the People's Republic of China

WS/T 806-2022 Basic technical standard for clinical hematology and body fluid analysis

国家市场监督管理总局、中国国家标准化管理委员会

GB 9706.216-2021 Medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Jilin Provincial Standard of the People's Republic of China

DB22/T 2915-2018 Technical requirements for blood testing of blood donor dogs

Shanxi Provincial Standard of the People's Republic of China

DB1407/T 52-2024 Safety Protection Guidelines for Medical Instrument and Equipment Inspection and Testing Personnel

Tianjin Provincial Standard of the People's Republic of China

DB12/ 402-2008 Estimation and Inspection of Blood Alcohol Content of Vehicle Personnel

Professional Standard - Agriculture

GB/T 42430-2023 Examination methods for ethanol, methanol, n-propanol, acetone, isopropanol and n-butanol in blood and urine
4 OIE陆生动物诊断试验和疫苗手册-2005 r-interferon test for bovine tuberculosis hematological examination

Professional Standard - Hygiene

WS/T 225-2002 Collection and processing of blood speciments for clinical chemistry
WS/T 406-2024 Quality Standards for Analysis of Common Items in Clinical Blood Tests
WS/T 406-2012 Analytical quality specifications for routine tests in clinical hematology
WS/T 225-2024 Collection and processing of blood specimens for clinical chemistry tests

其他未分类

BJY 201805 Supplementary test method for inspection items of cowhide-derived ingredients in Ejiao Buxue Oral Liquid

国家食品药品监督管理局

YY/T 1556-2017 Test methods for particle contamination of infusion，transfusion and injection equipments for medical use

司法部

SF/T 0115-2021 Determination of 45 toxic alkaloids in blood by liquid chromatography - tandem mass spectrometry

Professional Standard - Judicatory

SF/T 0116-2021 Determination of amphetamine-type stimulants, meperidine and ketamine in blood and urine

Indonesia Standards

SNI 16-4774-1998 Transfusion equipment for medical use - Blood taking set
SNI 16-4774.3-2002 Transfusion equipment for medical use - Part 3: Transfusion sets for single use

Japanese Industrial Standards Committee (JISC)

JIS T 0601-2-16:2008 Medical electrical equipment -- Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemodiafiltration equipment
JIS T 0601-2-16:2014 Medical electrical equipment -- Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
JIS T 0601-2-16:2022 Medical electrical equipment -- Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

British Standards Institution (BSI)

BS EN 60601-2-16:1998 Medical electrical equipment. Particular requirements for safety. Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
BS EN 60601-2-16:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
BS EN IEC 60601-2-16:2019 Medical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
BS EN ISO 3826-3:2007 Plastics collapsible containers for human blood and blood components - Blood bag systems with integrated features
BS EN ISO 3826-3:2006 Plastics collapsible containers for human blood and blood components. Blood bag systems with integrated features
BS 2463-1:1990 Transfusion equipment for medical use - Specification for collapsible containers for blood and blood components
21/30433073 DC BS EN IEC 60601-2-16. Medical electrical equipment. Part 2-16. Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
BS EN ISO 1135-4:2015(2016) Transfusion equipment for medical use Part 4 : Transfusion sets for single use, gravity feed
BS EN ISO 23500-2:2024 Preparation and quality management of fluids for haemodialysis and related therapies - Water treatment equipment for haemodialysis applications and related therapies
BS EN ISO 1135-5:2015 Transfusion equipment for medical use. Transfusion sets for single use with pressure infusion apparatus
BS EN 13927:2003(2008) Non-destructive testing - Visual testing - Equipment
BS EN 13927:2003 Non-destructive testing - Visual testing - Equipment
BS EN ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies. Water treatment equipment for haemodialysis applications and related therapies
BS EN ISO 15548-3:2008 Non-destructive testing - Equipment for eddy current examination - Part 3: System characteristics and verification
BS EN ISO 3452-4:1999 Non-destructive testing - Penetrant testing - Equipment
BS ISO 26722:2009 Water treatment equipment for haemodialysis applications and related therapies

Korean Agency for Technology and Standards (KATS)

KS C IEC 60601-2-16:2002 Haemodialysis, haemodiafiltration and haemofiltration equipment
KS C IEC 60601-2-16:2018 Medical electrical equipment — Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
KS P ISO 1135-3:2009 Transfusion equipment for medical use－Part 3：Blood-taking set

SCC

BS 7297-1:1990 Haemodialysers and related equipment-Specification for haemodialysers, 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.
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
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
CEI EN IEC 60601-2-16:2019 Medical electrical equipment Part 2: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
AAMI/IEC 60601-2-16:2012 Medical electrical equipment, Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment
CAN/CSA-C22.2 No.60601-2-16-2014 Medical electrical equipment — Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
AAMI/IEC 60601-2-16:2008 Medical electrical equipment, Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment
AAMI/IEC 60601-2-16:2018 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
CAN/CSA-C22.2 No.60601-2-16-2009 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
DANSK DS/EN 60601-2-16:2015 Medical electrical equipment – Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
DANSK DS/EN IEC 60601-2-16:2019 Medical electrical equipment – Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
CEI EN 60601-2-16:2018 Electrical medical equipment Part 2: Particular requirements relating to the basic safety and essential performance of hemodialysis, hemodiafiltration and haemofiltration equipment
IEC 60601-2-16:2008/COR1:2008 Corrigendum 1 - Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
DANSK DS/EN ISO 1135-4:2016 Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed
CSA Z364.2.2-1994(R1999) Water Treatment Equipment and Water Quality Requirements for Haemodialysis
AAMI RD62:2006 Water treatment equipment for hemodialysis applications
CSA Z364.2.2-1994 Water Treatment Equipment and Water Quality Requirements for Haemodialysis
CAN/CSA C22.2 No.60601-2-16-2014(R2019) Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:2012, MOD)
CSA Z364.2.2-2003(R2008) Water Treatment Equipment and Water Quality Requirements for Hemodialysis
DIN EN IEC 60601-2-16 E:2022 Draft Document - Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 62D/1912/CD:2021); Text in German and English
MIL MIL-B-37328-1975 BLOOD DETECTION TABLETS (NO S/S DOCUMENT)
DIN EN 60601-2-16 E:2006 Draft Document - Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 62D/556/CDV:2006); German version prEN 60601-2-16:2006
DIN 58903 E:2019 Draft Document - Haemostaseology - Deficient plasma - Requirements, preparation; Text in German and English
DIN IEC 60601-2-16 E:2016 Draft Document - Medical Electrical Equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 62D/1246/CD:2015)
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
DANSK DS/EN ISO 1135-5:2016 Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus
BS 5724-2-2.16:1989 Medical electrical equipment. Particular requirements for safety-Specification for haemodialysis equipment
CAN/CSA C22.2 No.60601-2-16-2009 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (Adopted IEC 60601-1-2008, third edition, 2008-04)
AAMI/ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 2: Water treatment equipment for haemodialysis applications and related therapies
CAN/CSA-C22.2 No.601.2.16-1992 Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Haemodialysis Equipment
DANSK DS/ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies – Part 2: Water treatment equipment for haemodialysis applications and related therapies

Standard Association of Australia （SAA）

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 3864:1991 Medical refrigeration equipment - For the storage of blood and blood products, and containers for the transport of blood and blood products
AS 3864.1:2012 Medical refrigeration equipment for storage of blood and blood products manufacturing requirements
AS 3864.2:2012 Care, maintenance, performance verification and calibration requirements for users of medical refrigeration equipment used to store blood and blood products

Australian/New Zealand Standard (AU-AS/NZS)

AS/NZS 3200.2.16:1999 Medical electrical equipment - Particular requirements for safety - Haemodialysis, haemodiafiltration and haemofiltration equipment
AS/NZS IEC 60601.2.16:2015 Medical electrical equipment - Special requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment

US-FCR

FCR 21 CFR PART 864-2015 HEMATOLOGY AND PATHOLOGY DEVICES
FCR 21 CFR PART 864-2014 HEMATOLOGY AND PATHOLOGY DEVICES
FCR 21 CFR PART 864-2013 HEMATOLOGY AND PATHOLOGY DEVICES
FCR 21 CFR PART 870-2015 CARDIOVASCULAR DEVICES
FCR 21 CFR PART 870-2013 CARDIOVASCULAR DEVICES

Danish Standards Foundation

DS/EN 60601-2-16/Corr.:2000 Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
DS/EN 60601-2-16:1999 Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
DS/ISO 1135-3:1993 Transfusion equipment for medical use. Part 3 : Blood-taking sets

Spanish Association for Standardization (UNE)

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 IEC 60601-2-16:2019 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (Endorsed by Asociación Española de Normalización in July of 2019.)
UNE-EN ISO 1135-4:2016 Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
UNE-EN ISO 1135-5:2016 Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)
UNE-EN ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2019)
ISO/FDIS 23500-2:2023 Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies

VN-TCVN

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

German Institute for Standardization

DIN EN 60601-2-16:1999 Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:1998); German version EN 60601-2-16:1998
DIN EN ISO 8362-5:2014 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
DIN 58903:2020-04 Haemostaseology - Deficient plasma - Requirements, preparation; Text in German and English
DIN 58903:2020 Haemostaseology - Deficient plasma - Requirements, preparation; Text in German and English
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 EN 60601-2-16:2016 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:2012); German version EN 60601-2-16:2015
DIN EN ISO 1135-4:2016-06 Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015); German version EN ISO 1135-4:2015
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 EN ISO 1135-5:2016-06 Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015); German version EN ISO 1135-5:2015
DIN ISO 1135-3:1987 Transfusion equipment for medical use; blood-taking set; identical with ISO 1135/3, edition 1986
DIN 58939-1:2000-03 Haemostaseology - Reference plasma - Part 1: Requirements, preparation
DIN 58930:2002-08 Haemostaseology - INR calibration plasmas - Requirements, preparation and use
DIN EN ISO 23500-2:2019-11 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2019); German version EN ISO 23500-2:2019 / Note: To be replaced ...
DIN EN ISO 23500-2:2022-12 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO/DIS 23500-2:2022); German and English version prEN ISO 23500-2:2022 / Not...

North Atlantic Treaty Organization Standards Agency

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

International Electrotechnical Commission (IEC)

IEC 60601-2-16:1998 Medical electrical equipment - Part 2-16: Particular requirements for safety of haemodialysis, haemodiafiltration and haemofiltration equipment
IEC 60601-2-16:2018 RLV Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
IEC 60601-2-16/COR1:2008 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
IEC 60601-2-16:2012 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
IEC 60601-2-16:2018 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Association Francaise de Normalisation

NF C74-322:2002 Medical electrical equipment - Part 2-16 : particular requirement for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment.
NF C74-322*NF EN 60601-2-16:2015 Medical electrical equipment - Part 2-16 : particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
NF C74-322*NF EN IEC 60601-2-16:2019 Medical electrical equipment - Part 2-16 : particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
NF 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 S93-308:1992 EXTRACORPORAL CIRCUITS. IDENTIFICATION OF CONCENTRATE SOLUTIONS FOR HEMODIALYSIS.
NF EN ISO 1135-3:2017 Transfusion equipment for medical use - Part 3: non-reusable blood sampling devices
NF EN 14334:2015 Équipements pour GPL et leurs accessoires - Inspection et essais des véhicules citernes routiers pour GPL
NF EN IEC 60601-2-16:2019 Medical electrical equipment - Part 2-16: particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration devices
NF S93-305-2*NF EN ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2 : water treatment equipment for haemodialysis applications and related therapies

GSO

GSO ISO 1135-3:2013 Transfusion equipment for medical use - Part 3: Blood-taking set
BH GSO IEC 60601-2-16:2016 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
OS GSO IEC 60601-2-16:2014 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
GSO ISO 1135-5:2021 Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus
BH GSO ISO 1135-5:2022 Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus
ISO 23500-2:2024 Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies

US-AAMI

AAMI RD62-2006 Water treatment equipment for hemodialysis application

KR-KS

KS C IEC 60601-2-16-2018 Medical electrical equipment — Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
KS C IEC 60601-2-16-2022 Medical electrical equipment — Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
KS P ISO 8536-14-2018(2023) Infusion equipment for medical use ─ Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact

Lithuanian Standards Office

LST EN 60601-2-16+AC-2000 Medical electrical equipment -- Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:1998) )

NATO - North Atlantic Treaty Organization

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

CENELEC - European Committee for Electrotechnical Standardization

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

Canadian Standards Association (CSA)

CSA C22.2 No.60601-2-16-2019 Medical electrical equipment — Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
CSA C22.2 No.60601-2-16-01-2001 Medical Electrical Equipment - Part 2-16: Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment Second Edition; IEC 60601-2-16:1998
CSA Z364.2.1-2013 Monitoring systems for hemodialysis equipment (Third Edition)
CSA Z23500-2-2020 Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies

European Committee for Electrotechnical Standardization（CENELEC）

EN IEC 60601-2-16:2019 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

RO-ASRO

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 11327/3-1983 RUBBER STOPPERS FOR BLOOD,PLASMA AND SOLUTION BOTTLES FOR INJECTIONS AND PERFUSIONS pH aqueous extract checking out
STAS 11326/2-1985 RUBBER STOPPERS FOR BLOOD, PLASMA AND AQUEOUS SOLUTION BOTTLES FOR INJECTIONS AND PERFUSIONS Pyrogenic impurities checking up
STAS 11326/4-1984 RUBBER STOPPERS FOR RECIPIENTS OF BLOOD, PLASMA AND AQUEOUS SOLUTIONS FOR INJECTIONS AND PERFUSIONS Hcmolityc impurities checking up
STAS 11327/2-1983 RUBBER STOPPERS FOR BLOOD, PLASMA AND SOLUTION BOTTLES FOR INJECTIONS AND PERFUSIONS Apparence, smell and taste checking out

IEC - International Electrotechnical Commission

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

RU-GOST R

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 ISO 8637-2012 Haemodialysers, haemofiltres and haemoconcentrators. Technical requirements and test methods
GOST ISO 8638-2012 Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemoconcentrators. Technical requirements and test methods
GOST 30324.16-1995 Medical electrical equipment. Part 2. Particular requirements for the safety of haemodialysis equipment
GOST R IEC 60601-2-16-2016 Medical electrical equipment. Part 2-16. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration

American National Standards Institute （ANSI)

ANSI/AAMI/IEC 60601-2-16,Ed. 4:2012 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
ANSI/AAMI/ISO 26722:2009 Water treatment equipment for hemodialysis applications and related therapies
ANSI/AAMI/ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies—Part 2: Water treatment equipment for haemodialysis applications and related therapies

VDE - VDE Verlag GmbH@ Berlin@ Germany

VDE 0750-2-16-2016 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis@ haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:2012); German version EN 60601-2-16:2015

SE-SIS

SIS SS-IEC 601-2-16:1991 Medical electrical equipment - Part 2: Particular requirements for the safety ofhaemodiafysis equipment

International Organization for Standardization (ISO)

ISO/DIS 23500-2 Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies
ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies

PL-PKN

PN Z55201-1991 Medical equipment.Blood taking sets for single use.Requirements and test methods

Military Standards (MIL-STD)

DOD A-A-54126-1990 PIPET-DILUENT, BLOOD, LABORATORY

CZ-CSN

CSN IEC 601-2-16:1994 Medical electrical equipment.Part 2:Particular requirements for safety of haemodialysis equipment

CEN - European Committee for Standardization

EN ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies