Good Refurbishment Practices for Medical Imaging Equipment
The medical industry follows a pattern of continuous advancement to meet patient needs, with innovations in medical technology plentiful at almost any point in time….
FDA Accreditation Scheme for Conformity Assessment (ASCA)
The U.S. Food & Drug Administration (FDA) has announced recognized accreditation bodies (ABs), including ANAB, for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot program….
ANSI/AAMI PB70 – Protective Apparel Liquid Barrier Requirements in Health Care
Patient care is a hands-on process, but this contact places unique stresses on healthcare professionals. Infection control practices, such as protective apparel, help protect patients…
ISO 10993 Biocompatibility and Risk Management
Burgeoning alongside advancements in the medical industry itself, innovations in medical devices have blossomed over the past few centuries. Even before a rolled up notebook…
ISO 14117:2019, EMC Tests for Implantable Medical Devices
An international standard, ISO 14117:2019, outlines electromagnetic compatibility (EMC) test protocols for various active implantable medical devices. The heart typically pumps at 60-100 beats per…
ISO 14644-3:2019, Cleanrooms & Controlled Environments, Test Methods
Excellence is expected in any industrial activity. Sometimes, this careful assuredness is an excessive welcome; a means to go beyond the bare minimum to instill…
ISO 11607 2019 Revisions, Sterilized Medical Device Packaging
Both standards in the international series for the packaging for terminally sterilized medical devices have been revised: ISO 11607-1:2019, which addresses materials, sterile barrier systems,…
ANSI/AAMI/ISO 11737-1:2018 – Determination of a Population of Microrganisms on Products for Sterilization
ANSI/AAMI/ISO 11737-1:2018 – Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microrganisms on products has been released….
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…