Compliance

List of standards for the evaluation of product compliance

Reference	Description
IEC 60601-1:2005 / A1:2012+A2:2020	Medical Electrical Equipment Part 1: General requirements for basic Safety & essential performance
IEC 60601-1-2:2014+A2:2020	Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
IEC 62366-1:2015	Medical devices – Part 1: Application of usability engineering to medical devices
IEC 62304:2006 + AMD1:2015	Medical device software – Software life cycle processes
ISO 15223-1:2021	Medical Devices- Symbols to be used with Medical device labels, labeling and information to be supplied – Part 1: General Requirements
ISO 14971:2019	Medical devices – Application of risk management to medical devices
IEC 63203-204-1:2023	Wearable electronic devices and technologies – Part 204-1: Electronic textile – Test method for assessing washing durability of e-textile products

Introduction