Classification System of International Standards

The International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) serve as primary bodies establishing international standards, supporting the foundation of global industrial activities and technological development.

These international standards can be classified through multiple approaches depending on their purpose and scope. Three widely recognized traditional classifications include:

• Process Standards
• Safety Standards
• Management System Standards

Process Standards

Process standards define methodologies for manufacturing processes, work procedures, measurement methods, and other operational aspects of products and services.

Examples include IEC 62304, which establishes software lifecycle processes for medical device software, and IEC 62366-1, which defines processes for usability engineering. These standards provide systematic approaches to ensure consistent quality and performance throughout the development and maintenance lifecycle.

Safety Standards

Safety standards establish requirements related to the protection of human life, health, and the environment.

Safety standards follow a hierarchical structure consisting of:

• Type A Standards (Basic Safety Standards): Define fundamental concepts, principles, and basic safety requirements applicable across broad industrial sectors
• Type B Standards (Group Safety Standards): Specify safety aspects applicable to a wide range of machinery and equipment, subdivided into:
  • Type B1: Standards addressing specific safety aspects (e.g., safety distances, surface temperatures)
  • Type B2: Standards addressing safety devices (e.g., two-hand control devices, interlocking devices, pressure-sensitive devices)
• Type C Standards (Product Safety Standards): Provide detailed safety requirements for specific types of machinery or equipment

Representative examples include ISO 12100 for machinery safety and the IEC 60601 series for electrical safety of medical electrical equipment.

ISO 14971: Dual Classification

ISO 14971 serves as an important example demonstrating that standards can embody characteristics of multiple categories. While primarily classified as a safety standard, it also incorporates substantial process standard elements.

As a Safety Standard: ISO 14971 functions as the principal product safety standard for risk management of medical devices. Its primary objective is to ensure the safety and performance of medical devices through systematic risk management.

As a Process Standard: Simultaneously, ISO 14971 specifies comprehensive risk management processes, providing a systematic approach for managing risks throughout the entire lifecycle of medical devices. This includes risk analysis, risk evaluation, risk control, and post-production information monitoring.

This dual nature reflects the modern approach to safety management, where both the outcome (safety) and the methodology (process) are equally essential.

Management System Standards

Management system standards systematize organizational operations and management methodologies.

Key examples include the Quality Management System (ISO 9001), Environmental Management System (ISO 14001), and Information Security Management System (ISO/IEC 27001). Additionally, ISO 45001 for occupational health and safety management and ISO 22000 for food safety management represent important management system standards.

Within the medical device industry, ISO 13485 plays a particularly crucial role. While based on ISO 9001, ISO 13485 incorporates specific considerations for medical devices’ unique characteristics. This standard specifies requirements for quality management systems throughout all phases including design and development, manufacturing, installation, and service provision of medical devices. Many countries have adopted it as a regulatory requirement for medical devices.

Interconnections and Integrated Applications

These standards do not exist in isolation but maintain complex interrelationships. For instance, in information security, ISO/IEC 27001 (management system requirements) and ISO/IEC 27002 (security controls) work closely together to form a comprehensive management framework. In manufacturing industries, combining process standards, safety standards, and management system standards enables comprehensive quality assurance and safety management.

The relationship between standards can be illustrated as follows:

Standard Type	Primary Focus	Representative Examples	Relationship to Other Types
Process Standards	Methods and procedures	IEC 62304, IEC 62366-1	Implements management system requirements; supports safety objectives
Safety Standards	Protection requirements	ISO 14971, IEC 60601 series, ISO 12100	Achieved through processes; managed by management systems
Management System Standards	Organizational framework	ISO 13485, ISO 9001, ISO/IEC 27001	Provides structure for processes; ensures safety compliance

Continuous Evolution and Global Impact

International standards undergo periodic reviews in response to technological advances and changing societal needs, with revisions implemented as necessary. This continuous update process maintains the effectiveness and contemporary relevance of standards.

Furthermore, these international standards play a vital role in removing technical barriers to international trade and promoting fair competition in global markets. When identical standards are adopted across different countries and regions, product and service compatibility is ensured, contributing to the facilitation of international transactions and harmonization of regulatory requirements.

The convergence of international standards has become increasingly important in the context of globalization, where manufacturers must navigate multiple regulatory jurisdictions. By adhering to internationally recognized standards, organizations can streamline their compliance processes and more efficiently access global markets while maintaining consistent levels of quality and safety.