What is an AAMI standard?
Quick facts about AAMI standards Standards are performance-based documents that serve to assist health care industry with performance, use, acceptance, and advancement of health technology by outlining performance and safety requirements for a device.
Which ANSI AAMI document is about quality?
The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements.
What is the AAMI standard for dialysate PH?
ANSI/AAMI RD52 – Dialysate for Hemodialysis.
What are AAMI standards for water quality in hemodialysis?
ANSI/AAMI/ISO 11663:2009 Quality of dialysis fluid for hemodialysis and related therapies (revision of RD52)…AAMI – Association for the Advancement of Medical Instrumentation.
| Microbiological Level | Water Standard | Water Action Level |
|---|---|---|
| Colony Forming Units | < 100 CFU/mL | ≥ 50 CFU/mL |
| Endotoxin Units | < 0.25 EU/mL | ≥0.125 EU/mL |
What is AAMI TIR?
A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI) Standards Board that addresses a particular aspect of medical technology.
What is the AAMI standard for dialysate pH?
What is a safety assurance case?
A safety assurance case is a methodology that uses a set of disciplines to structurally demonstrate that a safety claim is fulfilled, and that risk management is a systematic life cycle process to identify, control, and evaluate safety risks (as defined by your quality management system)iii.
What is the ANSI standard for eye protection?
ANSI Z87. 1 classifies eye protection as impact- or non-impact-rated. Impact-rated eye protection must pass certain high-mass and high-velocity tests, and provide eye protection from the side.
Why safety assurance is important?
Safety assurance encloses all planned and systematic actions necessary to provide the confidence level required, that the system is delivering as planned and achieves the acceptable level of safety consistently. It mirrors quality assurance but with focus solely on risk management and hazard identification.