IEC 62443-4-1:2018

IEC 62443-4-1 defines the requirements for a secure product development lifecycle for industrial automation and control systems (IACS) components. It specifies security practices that product suppliers must implement during the design, development, and maintenance of their products to reduce the likelihood of vulnerabilities and ensure defense-in-depth security capabilities.

Overview

Background

Published by the International Electrotechnical Commission (IEC) as part of the ISA/IEC 62443 series, this standard was developed to address the growing cybersecurity threats to industrial control systems and connected devices. It is increasingly applied to medical devices, especially those with network connectivity, as regulatory bodies recognize the need for secure development practices in healthcare technology.

Applicability

This standard applies to product development organizations that create components, systems, or software for industrial automation and control environments. In the medical device context, it is relevant to manufacturers of connected medical devices, health IT infrastructure, and IoT-enabled healthcare products. It is referenced by the EU MDR, FDA premarket cybersecurity guidance, and other regulatory frameworks as a recognized cybersecurity standard.

Core Principles

Security management and governance

Security requirements specification

Secure by design architecture

Secure implementation practices

Security verification and validation testing

Defect and vulnerability management

Patch management and security updates

Security documentation and guidance