Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential per...
ISO 80601-2-61:2017 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.
These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors,…
Healthcare organization management — Guidance for healthcare organizations’ response to the surging ...
This document provides guidance and considerations for healthcare organizations to deliver diagnostic tests timely and accurately in a pandemic by leveraging innovative approaches to overcome the limitations of laboratory capacity as follows:
– mitigating threats encountered in providing diagnostic services during a pandemic;
– consideration for quality assurance of diagnostic service provision…
Medical laboratories — Application of risk management to medical laboratories
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable to all aspects of the examinations and services of…
