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분야 | ISO/TC 150/SC 2 : Cardiovascular implants and extracorporeal systems |
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적용범위 | This document specifies minimum requirements for concentrates used for haemodialysis and related therapies. This document is addressed to the manufacturer of such concentrates. In several instances in this document, the dialysis fluid is addressed, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer. This document includes concentrates in both liquid and powder forms. It also includes additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. This document also specifies requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility. Concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility are excluded from the scope of this document. Although references to dialysis fluid appear herein, this document does not address dialysis fluid as made by the end user. This document also excludes requirements for the surveillance frequency of water purity used for the making of dialysis fluid by the dialysis facility. This document does not address bags of sterile dialysis fluid or sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid. This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use. This document does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012. |
국제분류(ICS)코드 | 11.040.40 : 외과. 보철술. 교정술용 이식 |
페이지수 | 22 |
Edition | 1 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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1 | ISO 23500-4:2024 | Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies | 2024-04-17 | 표준 |
2 | ISO 23500-4:2019 | Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies | 2019-02-15 | 구판 |
ISO 23500-3:2024 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies 상세보기
ISO 23500-4:2024 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies 상세보기
ISO 23500-5:2024 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies 상세보기
ISO 23500-2:2024 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies 상세보기
ISO 23500-1:2024 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements 상세보기
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 23500-3:2019 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies 상세보기
ISO 23500-1:2019 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements 상세보기
ISO 13959:2014 - Water for haemodialysis and related therapies 상세보기
ISO 13958:2014 - Concentrates for haemodialysis and related therapies 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification 상세보기
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기