An end stage renal disease (ESRD) facility must comply with all applicable technical standards, including those listed below.
- (1) American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI)/International Organization for Standardization (ISO) 23500-1:2019, Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements.
- (2) ANSI/AAMI/ISO 23500-2:2019, Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies.
- (3) ANSI/AAMI/ISO 23500-3:2019, Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies.
- (4) ANSI/AAMI/ISO 23500-4:2019, Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies.
- (5) ANSI/AAMI/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.
- (6) ANSI/AAMI/ISO 8637-1:2017, Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators.
- (7) ANSI/AAMI/ISO 8637-2:2018, Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters.
- (8) ANSI/AAMI/ International Electrotechnical Commission (IEC) 8637-3:2018, Extracorporeal systems for blood purification - Part 3: Plasmafilters.
- (9) ANSI/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.
- (10) ANSI/AAMI/IEC 60601-2-39:2018, Medical electrical equipment - Part 2 - 39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment.
- (11) AAMI Technical Information Report (TIR)72:2017, Dialysis fluid chemical composition.
- (12) AAMI TIR58:2021/(R)2025, Water testing methodologies.
- (13) AAMI TIR43:2021/(R)2025, Ultrapure dialysis fluid for hemodialysis and related therapies.
- (14) AAMI TIR77:2018, Sorbent-based regenerative hemodialysis systems.
- (15) ANSI/AAMI Renal Disease (RD)47:2020, Reprocessing of hemodialyzers.
- (16) Acute Dialysis: Survey Readiness Handbook, 2nd edition, 2021.
Source Note:The provisions of this §507.30 adopted to be effective December 23, 2025, 50 TexReg 8289.