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The Association for the Advancement of Medical Instrumentation (AAMI) create Standards for use in the medical device industry, as well as information to support and guide healthcare technology and sterilization practices. Their Standards are developed to help ensure the safe use and effectiveness of health technology.
AAMI Standards include all areas within the healthcare and medical device industries including manufacturing, testing, distribution, healthcare institutions, and more.
PRODUCT ADOPTION AND PROCESS EQUIVALENCE FOR ETHYLENE OXIDE STERILIZATION
A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
Human factors engineering—Design of medical devices
Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing
EVALUATION OF PARTICULATES ASSOCIATED WITH VASCULAR MEDICAL DEVICES
Clinical investigation of medical devices for human subjects—Good clinical practice
Medical electrical equipment—Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
Medical electrical equipment—Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
ECG trunk cables and patient leadwires
Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
Risk management guidance for combination products
It can be a challenge to know which Standards are right for your business. Here's an easy way for you to stay informed.
Keep on top of Standard news.
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