Hematology equipment

Hematology equipment, Total:55 items.

The international standard classification for "Hematology equipment" includes: Surgical instruments and materials , Implants for surgery, prosthetics and orthotics , Transfusion, infusion and injection equipment .

The Chinese standard classification for "Hematology equipment" includes: Extracorporeal circulation, artificial organ and prosthesis device .

Professional Standard - Medicine

YY 0054-2010 Haemodialysis equipment
YY/T 1834-2022 X-ray blood irradiation device
YY 0790-2010 Hemoperfusion equipment
YY/T 1945-2025 Blood Thawing Device
YY 0645-2008 Continuous Blood Purification Equipment
YY 0054-2003 Haemodialysis、haemodiafiltration and haemofiltration equipment
YY 0645-2018 Continuous blood purification equipment
YY 0790-2024 Hemoperfusion equipment
YY 0054-2023 Haemodialysis equipment

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

US Federal Contractor Registration (USFCR)

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

German Institute for Standardization

DIN 58903:2020 Haemostaseology - Deficient plasma - Requirements, preparation; Text in German and English
DIN 58903:2020-04 Haemostaseology - Deficient plasma - Requirements, preparation; Text in German and English
DIN 58903 E:2019 Draft Document - Haemostaseology - Deficient plasma - Requirements, preparation; Text in German and English
DIN 58930:2002-08 Haemostaseology - INR calibration plasmas - Requirements, preparation and use
DIN 58939-1:2000-03 Haemostaseology - Reference plasma - Part 1: Requirements, preparation
DIN 58932-1 E:2010 Draft Document - Haematology - Determination of the concentration of blood corpuscles in blood - Part 1: Blood collection, sample preparation, biological influence factors, interference factors
DIN 58932-1 E:2010-01 Haematology - Determination of the concentration of blood corpuscles in blood - Part 1: Blood collection, sample preparation, biological influence factors, interference factors
DIN 58905-1:2016-12 Haemostaseology - Blood collection - Part 1: Preparation of plasma from citrated venous blood for coagulation testing; Text in German and English
DIN 58932-1:2023 Haematology - Determination of the concentration of blood corpuscles in blood - Part 1: Blood collection, sample preparation, biological influence factors, interference factors; Text in German and English
DIN 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 58905-1 E:2015 Draft Document - Haemostaseology - Blood collection - Part 1: Preparation of plasma from citrated venous blood for coagulation testing; Text in German and English
DIN 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 58932-1:1996-12 Haematology - Determination of the concentration of blood corpuscles in blood - Part 1: Blood collection, sample preparation, biological influence factors, interference factors
DIN 58934-1:1997 Haematology - Control material for the CBC - Part 1: Control bloods

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

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

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 7297-1:1990 Haemodialysers and related equipment-Specification for haemodialysers, haemofilters and haemoconcentrators
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 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 60601-2-16:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
BS 7297-2:1990 Haemodialysers and related equipment-Specification for extracorporeal circuits for use with haemodialysers, haemofilters and haemoconcentrators

Korean Agency for Technology and Standards (KATS)

KS C IEC 60601-2-16:2002 Haemodialysis, haemodiafiltration and haemofiltration equipment

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

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

Spanish Association for Standardization (UNE)

AENOR UNE-EN 60601-2-16:1999 Electromedical equipment. Part 2-16: Particular requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration equipment.
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 CORR:2000 Electromedical equipment - Part 2-16: Particular requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration equipment.

Danish Standards Foundation

DS/EN 60601-2-16:1999 Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
DS/EN 60601-2-16/Corr.:2000 Medical electrical equipment - Part 2-16: Particular requirements for the safety 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

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

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

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.

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

Code of Federal Regulations (CFR)

CFR 21-864.1-2013 Food and Drugs. Part864:Hematology and pathology devices. Section864.1:Scope.

North Atlantic Treaty Organization Standards Agency

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