ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).
DO NOT USE THIS PRODUCT IN THE FOLLOWING SITUATIONS:
• Are under the legal age of purchase
• Are pregnant or breastfeeding
• Have heart disease, stomach or duodenal ulcers, liver or kidney problems, throat disease, or difficulty breathing due to bronchitis, emphysema, or asthma
• Have an overactive thyroid or pheochromocytoma a tumor of the adrenal gland that can affect blood pressure)
• Are taking certain medications, such as theophylline, ropinirole, or clozapine .