Guideline for Medication Safety
The Guideline for Medication Safety, AORN MAN-879D-2020, is a document published by the Association of periOperative Registered Nurses (AORN), which serves as the largest professional…
Changes to ISO/IEC 17025:2017, Calibration Laboratories Standard
ISO/IEC 17025:2017 – General requirements for the competence of testing and calibration laboratories has been released. This standard specifies the general guidelines for the competence, impartiality,…
AAMI TIR59: Integrating Human Factors into Medical Devices
Human factors, or ergonomics, strives to understand the interactions among humans and the other elements of a system. Integrating human factors engineering, otherwise known as…
Evaluating Functional Stress Due to Dental Implants
With the trust patients have in their doctor, whether ophthalmologist, gynecologist, pediatrician, or dentist, it is expected that the doctor has completed thorough risk analysis…
ANSI | Health Care | Lighting
ANSI/IES RP-29-22: Lighting Hospitals & Healthcare Facilities
Workplace lighting is a very nuanced subject, especially when the psychological and physiological effects that poor lighting can have on people are taken into account….
Amendment to ANSI/AAMI/IEC 62304:2006 – Medical Device Software – Software Life Cycle Processes
ANSI/AAMI/IEC 62304:2006/A1:2016 – Medical device software – Software life cycle processes – Amendment has been released. This document is an amendment to the existing ANSI/AAMI/IEC…
Sterilization of Medical Devices: Guidance for Manufacturers and Health Care Providers in Reprocessing
Guidance for Manufacturers For medical devices, sterilization is, unsurprisingly, crucial to patient health. For the best results, sterilization needs to begin with the manufacturers, who…
AAMI TIR14:2016 – Contract Sterilization Using Ethylene Oxide
Contract sterilization is rapidly growing within the medical device industry, as contracting the sterilization of manufactured health care products to an external organization simplifies the…
ISO 9626:2016 – Stainless Steel Needle Tubing for Medical Devices
In our last post, we discussed the changes made to ISO 7864:2016, the standard for sterile hypodermic needles for single use. However, ISO 7864 was…