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whole blood film

whole blood film, Total:360 items.

In the international standard classification, whole blood film involves: Medical equipment, Vocabularies, Medical sciences and health care facilities in general, Laboratory medicine, Veterinary medicine, Characteristics and design of machines, apparatus, equipment, Construction materials, Spices and condiments. Food additives, General methods of tests and analysis for food products, Pharmaceutics, Safety of machinery.


国家药监局, whole blood film

  • YY/T 0500-2021 Cardiovascular Implants Vascular Prostheses Tubular Vascular Grafts and Vascular Patches

卫生健康委员会, whole blood film

Professional Standard - Agriculture, whole blood film

International Organization for Standardization (ISO), whole blood film

  • ISO 7198:2016 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
  • IEC TR 62653:2012 Guidelines for the safe use of medical products in dialysis treatment

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, whole blood film

  • GB 18469-2001 Standards for whole blood and blood components quality
  • GB 18469-2012 Quality requirements for whole blood and blood components
  • GB 9706.2-2003 Medical electrical equipment--Part 2-16: Particular requirements for the safety of haemodialysis,haemodiafiltration and haemofiltration equipment
  • GB/T 27777-2011 Standards for safety application of rodenticides.Anticoagulant
  • GB/T 43279.3-2023 Specification for pre-examination procedures on venous whole blood for molecular in vitro diagnostic testing Part 3: Isolation of plasma circulating cell-free DNA
  • GB 14754-2010 National Food Safety Standard Food Additive Vitamin C (Ascorbic Acid)
  • GB 1903.55-2022 National Food Safety Standard Food Nutrition Fortifier L Potassium Ascorbate
  • GB 25581-2010 National Food Safety Standard Food Additive Potassium Ferrocyanide (Potassium Ferrocyanide)
  • GB 1903.52-2021 National Food Safety Standard Food Nutritional Fortifier Hemin Chloride

中华人民共和国国家卫生和计划生育委员会, whole blood film

  • WS/T 122-1999 Quantitative determination of hemoglobin in whole blood
  • WS/T 66-1996 Blood.Determination of cholinesterase activity.Spectrophotometric method--Hydroxylamine-ferric chloride method

Association Francaise de Normalisation, whole blood film

  • NF S94-204*NF EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems - Vascular Prostheses - Tubular vascular grafts and vascular patches
  • NF C74-322:2002 Medical electrical equipment - Part 2-16 : particular requirement for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment.
  • NF U47-101:2007 Animal health analytical methods - Isolation and identification of any specified Salmonella serovar(s) in birds
  • 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 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 S92-075-3*NF EN ISO 20186-3:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3 : isolated circulating cell free DNA from plasma
  • NF EN ISO 20186-3:2019 In vitro molecular diagnostic assays - Specifications for preanalytical processes for venous whole blood - Part 3: Circulating free DNA extracted from plasma
  • NF C74-322:1986 Medical electrical equipment. Part 2 : particular requirement for safety of haemodialysis equipment.
  • NF C74-382:1995 Medical electrical equipment. Part 2 : particular requirements for the safety of direct blood-pressure monitoring equipment.

Korean Agency for Technology and Standards (KATS), whole blood film

  • KS P ISO 7198:2018 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
  • 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 1929-3-2022 U-healthcare ─ glucose meter ─ Particular requirements for the basic safety and performance
  • KS P ISO 20186-3-2023 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma
  • KS C 1929-3-2017 U-healthcare ─ glucose meter ─ Particular requirements for the basic safety and performance

KR-KS, whole blood film

  • KS P ISO 7198-2018 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
  • KS P ISO 7198-2018(2023) Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
  • 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 C 1929-3-2017(2022) U-healthcare ─ glucose meter ─ Particular requirements for the basic safety and performance

British Standards Institution (BSI), whole blood film

  • BS EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches
  • 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 20186-3:2019 Molecular in-vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free DNA from plasma
  • PD CEN/TS 17742:2022 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free RNA from plasma
  • 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
  • PD IEC TR 62653:2020 Guideline for safe operation of medical equipment used for haemodialysis treatments
  • BS EN ISO 20186-1:2019 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated cellular RNA
  • BS EN ISO 20186-2:2019 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated genomic DNA

未注明发布机构, whole blood film

  • ANSI/AAMI/ISO 7198:2016 Cardiovascular implants and extracorporeal systems— Vascular prostheses—Tubular vascular grafts and vascular patches
  • DIN EN ISO 7198 E:2014-10 Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches (Draft)
  • DIN 58903 E:2019-04 Haemostaseology - Deficient plasma - Requirements, preparation
  • 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
  • DIN EN ISO 20186-3 E:2018-02 Procedure Specification for Preliminary Examination of Venous Whole Blood for Molecular In Vitro Diagnostic Examination Part 3: Isolation of Circulating Cell-Free DNA from Plasma (Draft)
  • CSA Z364.5-2017 Sécurité de l’installation et du fonctionnement de l’hémodialyse et de la dialyse péritonéale à domicile

SCC, whole blood film

  • AAMI/ISO 7198:2016 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
  • NS-EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches (ISO 7198:2016)
  • AENOR UNE-EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
  • DANSK DS/EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems – Vascular prostheses – Tubular vascular grafts and vascular patches (ISO 7198:2016)
  • DIN EN ISO 7198 E:2014 Draft Document - Cardiovascular implants and extracorporeal systems - Vascular Prostheses - Tubular vascular grafts and vascular patches (ISO/DIS 7198:2014); German version prEN ISO 7198:2014
  • ASTM STP 898-86 Vascular Graft Update - Safety Performance
  • 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
  • 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 60601-2-16:2018 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • BS PD CEN/TS 16835-3:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood-Isolated circulating cell free DNA from plasma
  • 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
  • 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)
  • 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)
  • BS PD IEC TR 62653:2020 Guideline for safe operation of medical equipment used for haemodialysis treatments
  • DANSK DS/IEC TR 62653:2020 Guideline for safe operation of medical equipment used for haemodialysis treatments
  • DANSK DS/IEC/TR 62653:2012 Guideline for safe operation of medical equipment used for haemodialysis treatments
  • DANSK DS/ISO 20186-3:2019 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for venous whole blood – Part 3: Isolated circulating cell free DNA from plasma
  • CSA ISO 20186-3:2022 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma
  • SN-CEN/TS 16835-3:2015 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma
  • DANSK DS/CEN/TS 16835-3:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma
  • 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)
  • DIN EN IEC 60601-2-16:2020 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:2018); German version EN IEC 60601-2-16:2019
  • CSA Z364.5-2022 Safety of installation and operation of hemodialysis and home peritoneal dialysis
  • DANSK DS/EN ISO 20186-3:2019 Molecular in-vitro diagnostic examinations – Specifications for pre-examination processes for venous whole blood – Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)
  • CSA Z364.5-2010(R2015) Safe installation and operation of hemodialysis and peritoneal dialysis in a home setting
  • CSA Z316.4-1994(R2002) Performance Specifications for Portable Whole Blood Glucose Monitor Systems for Use in Diabetes Management
  • CAN/CSA-C22.2 No.601.2.16-1992 Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Haemodialysis Equipment
  • BS PD CEN/TS 16835-1:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood-Isolated cellular RNA
  • DIN EN ISO 20186-3 E:2018 Draft Document - Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Cellular RNA - Part 3: Isolated circulating cell free DNA from plasma (ISO/DIS 20186-3:2018); German and English version...
  • BS PD CEN/TS 16835-2:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood-Isolated genomic DNA
  • CAN/CSA-C22.2 No.601.2.34-1998 Electrical medical devices - Part 2: Particular safety requirements for devices for monitoring direct blood pressure

AENOR, whole blood film

  • UNE-EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
  • UNE-EN 60601-2-16:1999 MEDICAL ELECTRICAL EQUIPMENT. PART 2-16: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT.

German Institute for Standardization, whole blood film

  • DIN EN ISO 7198:2017-07 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016); German version EN ISO 7198:2017 / Note: DIN EN 12006-2 (2009-08) remains valid alongside this standard until 2020-0...
  • DIN 58903:2000 Haemostaseology - Deficient plasma - Requirements, preparation
  • DIN EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016); German version EN ISO 7198:2017
  • 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 CEN/TS 17742:2022-07 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma; German version CEN/TS 17742:2022
  • 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 20186-3:2020-04 Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019); German version EN ISO 20186-3:2019
  • DIN EN ISO 20186-3:2020 Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)
  • DIN 58974-1:1982 Special laboratory medicine; determination of substrate concentration, D-glucose in whole blood, plasma, cerebrospinal fluid as well as urine; hexokinase-G6P-DH-method

国家卫生计生委, whole blood film

  • WS/T 550-2017 Guidelines for quality monitoring of whole blood and blood components
  • WS/T 569-2017 Plasmodium detection blood smear microscopy

Professional Standard - Education, whole blood film

  • JY 265-1987 Technical conditions for schistosomiasis eggs
  • JY 95-1982 Technical conditions for human blood smear (trial)
  • JY 244-1987 Pulmonary Vascular Injection Slicing Technical Conditions
  • JY 245-1987 Technical conditions for renal blood vessel injection sectioning
  • JY 263-1987 Technical conditions for schistosome male worm loading
  • JY 264-1987 Technical conditions for schistosome female worm loading
  • JY 266-1987 Technical conditions for schistosome miracidia
  • JY 267-1987 Technical conditions for cercariae of Schistosoma japonicum
  • JY 261-1987 Schistosoma japonicum technical specification

Group Standards of the People's Republic of China, whole blood film

  • T/CVMA 69-2021 Technical specification for animal blood smear preparation
  • T/CSBT 001-2019 Guideline for Haemovigilance
  • T/CAGR 011-2023 Guideline for whole blood viscosity testing by cone plate method
  • T/ZPP 065-2023 Health evaluation thresholds of 10 elements in human whole blood
  • T/QGCML 3239-2024 D-Safety protection device for sodium erythorbate production
  • T/GDWJ 005-2021 Health evaluation thresholds of 38 trace elements in human whole blood
  • T/STEI 0003-2024 Determination of multiple elements in whole blood — Inductively coupled plasma mass spectrometry
  • T/CHAS 10-2-20-2019 Quality and safety management of Chinese hospital—Part 2-20: Patient service——Blood purification
  • T/CHAS 10-2-13-2018 Quality and safety management of Chinese hospital——Part 2-13：Patient service——Clinical blood transfusion

Professional Standard - Medicine, whole blood film

  • YY/T 0659-2008 Automated coagulation analyzer
  • YY/T 0754-2009 Particular requirements of the safety and essential performance for blood pressure transmission tubes for use with invasive blood pressure monitoring equipment
  • YY/T 1856-2023 General safety requirements for blood, intravenous solution, and lavage fluid warmers
  • YY/T 0878.1-2013 Test for complement activation of medical devices.Part 1:Serum whole complement activation

Standard Association of Australia （SAA）, whole blood film

  • 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
  • AS 3503:1987 Whole blood - Determination of cadmium - Furnace atomic absorption spectrometric method
  • AS 4090:1993 Whole blood - Determination of lead content - Graphite furnace atomic absorption spectrometric method

RU-GOST R, whole blood film

  • GOST R 50267.16-2003 Medical electrical equipment. Part 2. Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
  • GOST R 50267.16-1993 Medical electrical equipment. Part 2. Particular requirements for safety of haemodialysis equipment
  • GOST R 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 50855-1996 Containers for blood and its components. Requirements for chemical and biological safety and methods of testing
  • GOST 30324.16-1995 Medical electrical equipment. Part 2. Particular requirements for the safety of haemodialysis equipment

Japanese Industrial Standards Committee (JISC), whole blood film

  • 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

Shanghai Provincial Standard of the People's Republic of China, whole blood film

  • DB31/ 486-2010 Requirements for Fixed Collection Sites
  • DB31/ 448-2009 Quality and safety requirements for edible livestock and poultry blood products

VN-TCVN, whole blood film

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

Danish Standards Foundation, whole blood film

  • 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/IEC/TR 62653:2012 Guideline for safe operation of medical equipment used for haemodialysis treatments

Guizhou Provincial Food Standard of the People's Republic of China, whole blood film

  • DBS52/ 059-2022 Food Safety Local Standard Blood Tofu
  • DBS52/ 067-2022 Food Safety Local Standards Hygienic Code for Processing of Edible Livestock and Poultry Blood Products

HU-MSZT, whole blood film

International Electrotechnical Commission (IEC), whole blood film

  • 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
  • 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/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 RLV Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
  • IEC TR 62653:2020 RLV Guideline for safe operation of medical equipment used for haemodialysis treatments
  • IEC TR 62653:2020 Guideline for safe operation of medical equipment used for haemodialysis treatments
  • IEC 60601-2-34:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of direct blood pressure monitoring equipment
  • IEC 60601-2-34:2000 Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment

Hunan Provincial Food Standard of the People's Republic of China, whole blood film

Lithuanian Standards Office , whole blood film

  • 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) )

Professional Standard - Commodity Inspection, whole blood film

  • SN/T 2497.9-2010 Test method of import and export dangerous chemicals-Part 9: Determination of serum hemolysin
  • SN/T 1222-2003 Detection of antibodies against(pullorum disease)-Protocol of whole blood plate agglutination test

Tianjin Provincial Standard of the People's Republic of China, whole blood film

  • DB12/T 750-2017 Blood donation house (vehicle) configuration and safety and health requirements

Canadian Standards Association (CSA), whole blood film

  • 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 Z364.5-2010 Safe installation and operation of hemodialysis and peritoneal dialysis in a home setting (First Edition)

CENELEC - European Committee for Electrotechnical Standardization, whole blood film

  • 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)

European Committee for Electrotechnical Standardization（CENELEC）, whole blood film

  • 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
  • HD 395.2.16 S1-1989 Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Heamodialysis Equipment

国家市场监督管理总局、中国国家标准化管理委员会, whole blood film

  • 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

ES-UNE, whole blood film

  • 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-CEN/TS 17742:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma (Endorsed by Asociación Española de Normalización in May of 2022.)
  • UNE-EN ISO 20186-3:2020 Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)

GSO, whole blood film

  • 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
  • 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

IEC - International Electrotechnical Commission, whole blood film

  • 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)

American National Standards Institute （ANSI), whole blood film

  • 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
  • IEC/TR 62653:2020 RLV Guideline for safe operation of medical equipment used for haemodialysis treatments

GOST, whole blood film

  • GOST R 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

European Committee for Standardization (CEN), whole blood film

  • FprCEN/TS 17742-2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma
  • prEN ISO 18703 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma
  • CEN/TS 17742:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma
  • PD CEN/TS 16835-3:2015 Molecular in vitro diagnostic e xaminations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma
  • prCEN ISO/TS 7552-2 Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood -- Part 2: Isolated DNA
  • prCEN ISO/TS 7552-1 Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood -- Part 1: Isolated RNA

Henan Provincial Food Standard of the People's Republic of China, whole blood film

  • DBS41/ 011-2016 Food Safety Local Standard Edible Livestock and Poultry Blood Products

National Metrological Technical Specifications of the People's Republic of China, whole blood film

  • JJF 1937-2021 Calibration specifications for fully automated blood bacterial culture analyzers

National Health Commission of the People's Republic of China, whole blood film

  • GB 1886.43-2015 National Food Safety Standard Food Additive Calcium Ascorbate
  • GB 1886.44-2016 National Food Safety Standard Food Additive Sodium Ascorbate
  • GB 5009.86-2016 Determination of Ascorbic Acid in National Food Safety Standard Food
  • GB 1886.49-2016 National food safety standard food additive D-isoascorbic acid
  • GB 1886.28-2016 National Food Safety Standard Food Additive Sodium Erythorbate
  • GB 1886.230-2016 National Food Safety Standard Food Additive Ascorbyl Palmitate

SE-SIS, whole blood film

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

American Society for Testing and Materials (ASTM), whole blood film

  • ASTM F1984-99(2018) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
  • ASTM F1984-99(2013) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
  • ASTM F2394-07(2022) Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System

国家食品药品监督管理局, whole blood film

  • YY/T 1500-2016 Medical device pyrogen test Monocyte activation test Human whole blood ELISA method

Sichuan Provincial Standard of the People's Republic of China, whole blood film

  • DB51/T 1420-2012 Technical specifications for the quarantine of Echinococcus granulosus in animals - whole blood gold standard immunofiltration method

CZ-CSN, whole blood film

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

BE-NBN, whole blood film

  • NBN-HD 395.2.16-1994 Medical electrical equipment. Part 2: Particular requirements for the safety of haemodialysis equipment

Jiangsu Provincial Standard of the People's Republic of China, whole blood film

  • DB32/T 4155.8-2021 National Health Information Platform Shared Dataset Specification Part 8: Therapeutic Blood Transfusion

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