ГОСТ Р МЭК 60601-2-16-2022 Изделия медицинские электрические. Часть 2-16. Частные требования безопасности с учетом основных функциональных характеристик к аппаратам для гемодиализа, гемодиафильтрации и гемофильтрации

[1]

AAMI TIR Sorbent-Based Regenerative Hemodialysis Systems

[2]

ASTM E1153, ASTM E1153-14 Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate, Hard, Nonporous Non-Food Contact Surfaces

[3]

AOAC 964, Association of analytical communities - Method 964.02 - Pseudomonas aeruginosa

[4]

CSN EN 14885, Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics

[5]

Guyton, AC. Circulatory Shock and Physiology of Its Treatment. Guyton AC, editor, Textbook of Medical Physiology Eighth Edition. W.B. Saunders Company, 1991, p.263-71

[6]

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

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Второе издание отменено.

[7]

IEC 60601-2-24, Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers

[8]

IEC 60601-2-39, Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

[9]

IEC 80001 -1:2010, Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

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Заменен на IEC 80001-1:2021 "Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software".

[10]

IEC PAS 63023, Medical electrical system - Input interface for haemodialysis equipment for use of external alarming device

[11]

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

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ISO 8637-1:2017 заменяет ISO 8637:2010 и ISO 8637:2010/AMD1:2013.

[12]

ISO 8637-2, Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

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ISO 8637-2:2018 заменяет ISO 8638:2010.

[13]

ISO 11197, Medical supply units

[14]

ISO 15883 (all parts), Washer-disinfectors

[15]

ISO 23500-1, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements

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ISO 23500-1 заменяет ISO 23500:2014.

[16]

ISO 23500-2, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies

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ISO 23500-2 заменяет ISO 26722:2014.

[17]

ISO 23500-3, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies

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ISO 23500-3 заменяет ISO 13959:2014.

[18]

ISO 23500-4, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies

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      ISO 23500-4 заменяет ISO 13958:2014.

[19]

ISO 23500-5, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies

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ISO 23500-5 заменяет ISO 11663:2014.

[20]

JIS Z 2801, Antibacterial products - Test for antibacterial activity and efficacy

[21]

Jonsson P, Stegmayr B, Polaschegg HD. Central dialysis catheter LEAKAGE CURRENT distribution. Nephrol Dial Transplant 2007; 22:vi519

[22]

Jonsson P, Stegmayr BG. Current leakage in hemodialysis machines may be a safety risk for patients. Artif Organs 2000; 24:977-81

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Polaschegg HD., Levin N. Hemodialysis machines and monitors. WINCHESTER, J., KOCH, R., LINDSAY, R., RONCO, C., HORL, W., Editors. Replacement of Renal Function by Dialysis, 5th Edition. Kluwer Academic Publishers, 2004, p.323-447

[24]

Polaschegg HD, Stegmayr BG, et.al. Microbubbles of air during hemodialysis - Negligible for the patient? (Internat J Artif Organs, Vol 34 (8):654, 2011)

[25]

Polaschegg HD, Presence of micro bubbles in hemodialysis. Physical basis, technical considerations and regulations (Internat J Artif Organs, Vol 34 (8):635, 2011)

[26]

Starmer CF, Mcintosh HD, Whalen RE, Electrical hazards and cardiovascular function (N Engl J Med Vol 284: 181-6, 1971)

[27]

Stegmayr B, Air contamination during hemodialysis should be minimized (Hemodialysis International, Vol 21 (2): 168-172, 2017)

[28]

Zafren K, Mechem CC, Accidental hypothermia in adults, Danzl DF, ed. UpToDate. Waltham, MA: UpToDate Inc. [viewed 2018-01-04]. Available at: http://www.uptodate.com

[29]

National Kidney Foundation guidelines (KDOKI guidelines), Guideline 3: Measurement of Dialysis - Urea Kinetics [viewed 2018-01-04]. Available at: https://www.kidney.org/professio nals/guidelines/hemodialysis2015

[30]

European best practice guidelines for haemodialysis, 3. Dialysis dose methodology and 4. Minimum adequate dialysis [viewed 2018-01-04]. Available at: http://www.european-renal-best-practice.org/content/ebpg-european-best-practice-guidelines-documents

[31]

ISO 14971:2007, Medical devices - Application of risk management to medical devices

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Заменен на ISO 14971:2019 "Medical devices - Application of risk management to medical devices".