Technical requirements for hematology analyzers

Technical requirements for hematology analyzers, Total:138 items.

The international standard classification for "Technical requirements for hematology analyzers" includes: Laboratory medicine , Implants for surgery, prosthetics and orthotics , Measurement of electrical and magnetic quantities , Transfusion, infusion and injection equipment , Particle size analysis. sieving , Measuring instruments , Protection against crime .

The Chinese standard classification for "Technical requirements for hematology analyzers" includes: Medical laboratory equipment , Extracorporeal circulation, artificial organ and prosthesis device , Water supply and draining instrument and equipment , Electronic measurement and equipment in general , Sieving, Sieve Plate and Sieve Screen , Physical property analyzer , Chemical Measurement , Guard and alarm system , Social and public safety in general , Sanitation in general .

Professional Standard - Medicine

YY 0793.1-2010 Technical requirements of water treatment equipments for haemodialysis applications and related therapies—Part 1:For multi-beds haemodialysis
YY/T 1452-2016 Dry hematology analyzer(centrifuge method)
YY 0793.2-2011 Technical requirements of water treatment equipments for haemodialysis applications and related therapies—Part 2:For single-bed haemodialysis
YY/T 0475-2004 General technical requirements for urine analyzer
YY/T 0456.3-2014 Reagents for hematology analyzer―Part 3:Diluent
YY/T 0653-2017/XG1-2022 Hematology analyzer|| inlucdes Amendment 1
YY/T 1245-2014 Automatic blood grouping analyzer
YY/T 1414-2016 Liquid line solenoid valve for haemodialysis equipment
YY/T 0456.2-2014 Reagents for hematology analyzer―Part 2:Hemolysin
YY/T 0456.3-2003 Regents for hematology analyzer use—Part 3:Diluent
YY/T 1784-2021 Blood gas analyzer
YY/T 0701-2021 Calibrator for hematology analyzer
YY/T 0653-2017 Hematology analyzer
YY/T 0456.1-2014 Reagents for hematology analyzer―Part 1:Rinse
YY/T 0456.1-2003 Regents for hematology analyzer use - Part 1: Rinse
YY/T 0659-2017 Blood coagulation analyzer
YY/T 0653-2008 Hematology analyzer

Group Standards of the People's Republic of China

T/NBPIA 002-2020 Technical Specification for quality of dialysate and online hemodialysis replacement fluid
T/CAME 46-2022 Essential requirements for engineering technical personnel of hemodialysis
T/CASME 133-2022 General technical requirements for sheet metal housing for mobile analyzers
T/NBPIA 003-2020 Technical Specification for quality of hemodialysis water

Jilin Provincial Standard of the People's Republic of China

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

Professional Standard - Environmental Protection

HJ/T 97-2003 The technical requirement for water quality automatic analyzer of electroconductivity
HJ/T 102-2003 The technical requirement for water quality automatic ananlyzer of total nitrogen
HJ/T 96-2003 The technical requirement for water quality automatic analyzer of PH
HJ/T 101-2003 The technical requirement for water quality automatic analyzer of ammonia
HJ/T 98-2003 The technical requirement for water quality automatic analyzer of turbidity
HJ/T 99-2003 The techinical requirement for water quality automatic analyzer of dissolved oxygen
HJ/T 103-2003 The technical reqirement for water quality automatic ananlyzer of total phosphorous
HJ/T 104-2003 The technical requirement for water quality automatic analyzer of total organic carbon

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

GB/T 41949-2022 Particle─Laser particle size analyser─Technical requirements
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
GB/T 44223-2024 Nanotechnologies—Technical requirements for dynamic light scattering particle size analyzers
GB/T 31493-2015 Technical requirements for digital audio video analyzer
GB 9706.2-2003 Medical electrical equipment—Part 2-16:Particular requirements for the safety of haemodialysis,haemodiafiltration and haemofiltration equipment
GB/T 13074-1991 Terms of blood purification Hemodialysis and hemofiltration

National Metrological Verification Regulations of the People's Republic of China

JJG 553-1988 Blood Gas Acid -Base Analyser

Hunan Provincial Standard of the People's Republic of China

DB43/T 2452-2022 General technical requirements for heat loss rate analyzer

Professional Standard - Public Safety Standards

GA/T 1154.4-2018 Video analysis instrument-Part 4:Technical requirements for face analysis
GA/T 1154.1-2014 Video analysis instrument—Part 1:General technical requirements
GA 1154.1-2014 Video analysis instrument-Part 1 : General technical requirements
GA/T 1154.4-2018(1) Video Image Analyzer Part 4: Technical Requirements for Face Analysis

Jiangsu Provincial Standard of the People's Republic of China

DB32/T 3545.7-2024 Blood Purification Treatment Technology Management Part 7: Water Quality Testing Standards for Hemodialysis

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

JJF 1541-2015 Calibration Specification for Hemodialysis Equipment Tester
JJF 1937-2021 Calibration Specification for Automated Blood Bacteria Culture Analyzers

Professional Standard - Hygiene

WS/T 406-2012 Analytical quality specifications for routine tests in clinical hematology

Gosstandart of Russia

GOST R ISO 8637-1999 Haemodialysers, haemofilters and haemoconcentrators. Technical requirements and test methods
GOST R ISO 8638-1999 Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators. Technical requirements and test methods
GOST ISO 8638-2012 Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemoconcentrators. Technical requirements and test methods
GOST R 55991.6-2014 In vitro diagnostics medical devices. Part 6. Automatic analyzers for hematology tests. Technical requirements for public procurement
GOST 27874-1988 Extracorporeal blood purification dialyzers. General requirements and testing methods
GOST ISO 8637-2012 Haemodialysers, haemofiltres and haemoconcentrators. Technical requirements and test methods
GOST R 55992.1-2014 In vitro diagnostic medical devices for fluorescent and immunofluorescent analysis of ?dried spot? of newborn's blood. Part 1. Instruments and accessories for fluorescent and immunofluorescent analysis of ?dried spot? of newborn's blood. Technical require
GOST R 50267.16-1993 Medical electrical equipment. Part 2. Particular requirements for safety of haemodialysis equipment
GOST R 50267.16-2003 Medical electrical equipment. Part 2. Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration 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
GOST R 55991.5-2014 In vitro diagnostics medical devices. Part 5. Automatic analyzers for blood gas, metabolite and acid-base balance assessment. Technical requirements for public procurement
GOST 29024-1991 Turbodimetric and nephelometric analysers of liquid. General technical requirements and testing methods
GOST 23787.1-2023 Solutions of antiseptic compound ХМК. Technical requirements, safety requirements and methods of analysis

International Organization for Standardization (ISO)

ISO/DIS 13959:1997 Water for Haemodialysis or Haemodiafiltration - Requirements
ISO/FDIS 8637-1:2023 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO/DIS 8637-1 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO/CD 8637-1 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Czech Standards Institute (UNMZ)

CSN 85 6210-1989 Haemodialyser. General technical requirements and testing methods
CSN 99 4178-1990 Grain testers. Technical requirements

Spanish Association for Standardization (UNE)

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.
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.
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 8637-1:2020 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
UNE-EN 60601-2-16:2015 Medical electrical equipment - Part 2-16: Basic safety requirements and important functional characteristics of hemodialysis, hemodiafiltration and hemofiltration equipment

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 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 8637-1-2023 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

British Standards Institution (BSI)

BS 5724-2-2.16:1989 Medical electrical equipment. Particular requirements for safety-Specification for haemodialysis equipment
BS EN IEC 60601-2-16:2025 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 60601-2-16:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Swedish Institute for Standards

SS-EN 60601-2-16:1998 Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

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
DANSK DS/ISO 8637-1:2024 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
DS/EN ISO 8637-1:2021 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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 ISO 8637-1:2021 Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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

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

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

Japanese Industrial Standards Committee (JISC)

JIS K 0701:1988 Glucose Analyzer
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

Canadian Standards Association (CSA)

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 Water Treatment Equipment and Water Quality Requirements for Haemodialysis
CSA Z364.2.2-2003(R2008) Water Treatment Equipment and Water Quality Requirements for Hemodialysis
CSA Z364.2.2-1994(R1999) Water Treatment Equipment and Water Quality Requirements for Haemodialysis
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
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
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
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
CSA C22.2 No.60601-2-16-2019(R2024) Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Association Francaise de Normalisation

NF S93-315:2008 Fluids for hemodialysis - Requirements and user recommendations
NF C74-322:2002 Medical electrical equipment - Part 2-16 : particular requirement for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment.
NF EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Part 1: hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
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 C74-322*NF EN IEC 60601-2-16:2025 Medical electrical equipment - Part 2-16 : particular requirements for the basic safety and essential performance 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 EN ISO 8637-2:2024 Extracorporeal systems for blood purification - Part 2 : extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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 S93-302-2*NF EN ISO 8637-2:2024 Extracorporeal systems for blood purification - Part 2 : extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

US Federal Contractor Registration (USFCR)

FCR 21 CFR PART 630-2013 GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES
FCR 21 CFR PART 630-2015 GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES

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

International Electrotechnical Commission (IEC)

IEC 60601-2-16:2025 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
IEC 60601-2-16:2025 RLV 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 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
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

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) )

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 8637-1:2017 Extracorporeal systems for blood purification— Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Indonesia Standards

SNI 16-6071-1999 Haemodialysers, haemofilters and haemoconcentrators

Association for Electrical, Electronic & Information Technologies (VDE)

VDE 0750-2-16 E*DIN IEC 60601-2-16:2016-02 Particular requirements for the basic safety and essential performance of medical electrical equipment for hemodialysis, hemodiafiltration and hemofiltration equipment
VDE 0750-2-16 E*DIN EN 60601-2-16:2006-11 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)

Comitato Elettrotecnico Italiano

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

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

The Directorate General of Specifications and Metrology (DGSM)

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

Association for the Advancement of Medical Instrumentation

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 60601-2-16:2012 Medical electrical equipment, Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment
AAMI/ISO 8637-1:2017 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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

Bureau of Indian Standards

IS/ISO 8637-1-2017 Extracorporeal Systems for Blood Purification Part 1 Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators

European Committee for Electrotechnical Standardization（CENELEC）

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)
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
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 IEC 60601-2-16:2025 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Kingdom of Bahrain Testing and Metrology Directorate

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

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