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분야 | ISO/TC 150/SC 2 : Cardiovascular implants and extracorporeal systems |
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적용범위 | 1.1 General This document is the base standard for a number of other standards dealing with water treatment equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, this document functions as a recommended practice. This document does not address clinical issues that might be associated with inappropriate usage of the water, dialysis water, concentrates, or dialysis fluid. Healthcare professionals involved in the provision of treatment for kidney failure should make the final decision regarding the applications with which these fluids are used, for example, haemodialysis, haemodiafiltration, high-flux haemodialysis, and the reprocessing of dialysers, and need to be aware of the issues that the use of inappropriate fluid quality raises in each of the therapies. The concepts incorporated in this document should not be considered inflexible or static. The recommendations presented here should be reviewed periodically in order to assimilate increased understanding of the role of dialysis fluid purity in patient outcomes and technological developments. 1.2 InclusionsThis document addresses the user's responsibility for dialysis fluid once the equipment used in its preparation has been delivered and installed. For the purposes of this document, dialysis fluid includes: a) dialysis water (see 3.17 for definition) used for the preparation of dialysis fluid and substitution fluid, b) dialysis water used for the preparation of concentrates at the user's facility, c) concentrates, d) the final dialysis fluid and substitution fluid. The scope of this document includes a) the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused, b) equipment used to prepare concentrate from powder or other highly concentrated media at a dialysis facility, and c) preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates. NOTE Because water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document. 1.3 ExclusionsThis document does not apply to sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis. |
국제분류(ICS)코드 | 11.040.40 : 외과. 보철술. 교정술용 이식 |
페이지수 | 87 |
Edition | 1 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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1 | ISO 23500-1:2024 | Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements | 2024-08-16 | 표준 |
2 | ISO 23500-1:2019 | Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements | 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 23500-4:2019 - 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
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