Medical device standards/ What are the Most Important Medical device standards

00:00 Introduction
00:25 ISO 13485- This is the International standard for Quality management systems Requirements for regulatory purposes. It contains a comprehensive quality management system for the design and manufacturing of medical devices
00:41 IEC-60601, This standard stands for Medical electrical equipment safety standards. I E C 60601 is a series of international standards, published by the International Electrotechnical Commission (IEC), that specify safety and performance requirements for medical electrical equipment and is widely recognised as the benchmark for medical device safety.
01:05 ISO14971, This is the I S O standard for Risk management for medical devices. This standard outlines a process to identify the hazards associated with medical devices. It helps ensure the safety of a medical device during the product's life cycle
01:25 I S O 10993: This is the standard for Biological evaluation of medical devices. I S O 10993 comprises a series of international standards for the evaluation of biomedical devices and associated biological risk. This includes specific standards for certain material classes, such as ceramics or metals, as well as evaluation and testing within a risk-managed process.
01:53 FDA 21 CFR Part 820:This is the standard for Quality System Regulation- in USA. This ensures that all medical devices created and developed within the US market are safe and follow satisfactory quality processes at all stages of development.
02:11 I E C 62304: This is an international standard published by the International Electrotechnical Commission. The standard specifies life cycle requirements for the development of medical software and software within medical devices.
02:29 I S O 11607: I S O 11607 is the principal guidance document for validating terminally sterilized medical device packaging systems. Packaging must comply with I S O 11607 in order to satisfy European regulations and obtain a CE Mark. I S O 11607 is also an FDA Recognized Consensus Standard.
02:54 I S O 14155: This is the standard for Clinical investigation of medical devices for human subjects.This international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes.
03:17 I S O 15223: This is the standard Symbols for medical device labelling.This document specifies symbols used to express information supplied for a medical device. This document is applicable yto symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements.
04:10 I S O 15189: This standard specifies requirements for quality and competence in medical laboratories. I S O 15189 can be used by medical laboratories in developing their quality management systems and assessing their own competence.