Preoperative Pregnancy Testing, As Addressed by Standard Practices
Various medical operations or procedures can be considered high-risk for patients under specific conditions. For pregnant patients, both the patient and the fetus can be […]
Medical Industry
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, […]
Integrating Human Factors into Design Controls of 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 […]
Detecting Bacteria in the Food Chain: ISO 21528-2:2017
International standard ISO 21528-2: 2017: Microbiology of the food chain – Horizontal method for the detection and enumeration of Enterobacteriaceae specifies a method by which users […]
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/IES RP-29-20: 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: Guidelines for Manufacturers and Health Care Providers in Reprocessing
Guidelines for Manufacturers For medical devices, sterilization is, unsurprisingly, crucial to patient health. For the best results, sterilization needs to begin with the manufacturers, who […]
Good Manufacturing Practices (GMP) for Pharmaceutical Excipients
Pharmaceutical excipients are essential to the safety, quality, and efficacy of drug products, as they impact a variety of factors influencing how a drug enters […]