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분야 | ISO/TC 150/SC 2 : Cardiovascular implants and extracorporeal systems |
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적용범위 | ISO 13958:2014 specifies minimum requirements for concentrates used for haemodialysis and related therapies. For the purpose of ISO 13958:2014, "concentrates" are a mixture of chemicals and water, or chemicals in the form of dry powder or other highly concentrated media, that are delivered to the end user to make dialysis fluid used to perform haemodialysis and related therapies. ISO 13958:2014 is addressed to the manufacturer of such concentrates. ISO 13958:2014 includes concentrates in both liquid and powder forms. Also included are additives, also called spikes, which are chemicals that may be added to the concentrate to increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. ISO 13958:2014 also gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility. |
국제분류(ICS)코드 | 11.040.40 : 외과. 보철술. 교정술용 이식 |
페이지수 | 26 |
Edition | 3 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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1 | ISO 13958:2014 | Concentrates for haemodialysis and related therapies | 2014-03-17 | 폐지 |
2 | ISO 13958:2009 | Concentrates for haemodialysis and related therapies | 2009-04-15 | 구판 |
3 | ISO 13958:2002 | Concentrates for haemodialysis and related therapies | 2002-09-19 | 구판 |
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ISO 23500-5:2019 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies 상세보기
ISO 23500-4:2019 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies 상세보기
ISO 23500-3:2019 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies 상세보기
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