ISO 12100

ISO 12100
Title	ISO 12100
Status	Published
Started	2003
Year	2010
Organization	International Organization for Standardization
Domain	Machinery safety

ISO 12100 ISO 12100 is an international standard establishing general principles for design and risk assessment of machinery to ensure safety. It synthesizes guidance from leading technical bodies and industrial stakeholders to provide a harmonized methodology for identifying hazards, estimating risks, and specifying risk reduction measures. The standard interfaces with sector-specific standards and is used by designers, manufacturers, certification bodies, and regulators worldwide.

Overview

ISO 12100 was developed under the auspices of the International Organization for Standardization technical committee for machinery, drawing expertise from national bodies such as the British Standards Institution, Deutsches Institut für Normung, Association Française de Normalisation, American National Standards Institute, Standards Australia, Japan Industrial Standards Committee, and Instituto Argentino de Normalización y Certificación. The standard consolidates concepts that appear in sector standards from organizations like European Committee for Standardization, International Electrotechnical Commission, Underwriters Laboratories, German Social Accident Insurance, Occupational Safety and Health Administration, and industry consortia including CEN/TC 114 and ISO/TC 199. Its adoption has been influenced by landmark industrial incidents, regulatory reforms such as the Machinery Directive 2006/42/EC, and international safety campaigns associated with institutions like the World Health Organization and International Labour Organization.

Scope and Objectives

ISO 12100 sets out general principles for the design of safe machinery, addressing hazard identification, risk estimation, risk evaluation, and risk reduction. The standard aims to harmonize practices used by manufacturers such as Siemens, General Electric, Toyota, Bosch, Mitsubishi Heavy Industries, Caterpillar Inc., ABB Group, and Schneider Electric and by certification bodies like TÜV Rheinland, SGS S.A., and Bureau Veritas. Objectives include facilitating compliance with legal frameworks exemplified by the European Commission, national ministries such as the United States Department of Labor, and regulatory authorities like Health and Safety Executive and Federal Institute for Occupational Safety and Health (BAuA). It supports international trade by aligning with conformity assessment schemes administered by entities including the World Trade Organization and United Nations Economic Commission for Europe.

Key Concepts and Terminology

The standard defines terms and concepts that interface with technical domains referenced by bodies such as ISO/IEC JTC 1, ISO 13849, IEC 62061, IEC 61508, ISO 45001, and ISO 9001. Core terminology connects to machine life cycles addressed in standards and guides produced by European Agency for Safety and Health at Work, National Institute for Occupational Safety and Health, International Labour Organization, Occupational Safety and Health Administration, and research institutions like Fraunhofer Society and TNO. Key concepts include hazard, hazardous situation, harm, risk, risk assessment, risk reduction, safeguard, protective device, and residual risk—terms used by manufacturers and regulators such as Ford Motor Company, Honda, Nissan, John Deere, Komatsu, Hitachi Construction Machinery, and testing laboratories such as Intertek. Vocabulary aligns with international instruments like the Aarhus Convention in relation to information disclosure and participatory processes in safety.

Risk Assessment and Risk Reduction Principles

ISO 12100 prescribes a structured risk assessment methodology combining identification, estimation, and evaluation stages used by engineering teams at companies such as Rolls-Royce Holdings, Airbus, Boeing, Lockheed Martin, Raytheon Technologies, ThyssenKrupp, ArcelorMittal, and Dow Chemical Company. It emphasizes inherently safe design measures, safeguarding, and complementary protective measures, mirroring approaches adopted in standards from IEC, ANSI, DIN, and BSI. Techniques referenced in application include failure mode and effects analysis practiced at firms like Procter & Gamble, Unilever, 3M, Honeywell International, and Emerson Electric, and hazard analysis tools used by NASA, European Space Agency, United States Nuclear Regulatory Commission, and International Atomic Energy Agency. The hierarchy of risk reduction promotes elimination, substitution, engineering controls, administrative controls, and personal protective equipment as seen in programs by Siemens Healthineers, GE Healthcare, and Philips.

Implementation and Application in Machinery Safety

Implementation of ISO 12100 occurs across sectors including automotive, aerospace, construction, pharmaceuticals, food and beverage, and energy, involving companies such as Volkswagen Group, BMW, Airbus, Siemens Gamesa, TotalEnergies, ExxonMobil, and Shell plc. Practical application is integrated into product development life cycles used by design houses like IDEO, Frog Design, and engineering consultancies including Arup, Jacobs Engineering Group, AECOM, and WSP Global. Compliance informs conformity assessment and CE marking activities coordinated with notified bodies including TÜV SÜD and DNV GL, and is incorporated into procurement specifications used by public agencies like the United Nations and multinational corporations such as Amazon (company), Walmart, and IKEA. Training and competency frameworks invoking ISO 12100 are delivered by professional institutions such as Institution of Mechanical Engineers, American Society of Mechanical Engineers, IEEE, Royal Society of Medicine, and Chartered Institute of Ergonomics and Human Factors.

Revision History and Related Standards

ISO 12100 has evolved through editions influenced by developments in functional safety, risk management, and machine design, interacting with normative documents like ISO 13849-1, ISO 13849-2, IEC 62061, IEC 61508, ISO 14121, ISO 20607, and EN ISO 12100. Revisions reflect inputs from national committees and stakeholder organizations including European Commission Directorate-General for Enterprise and Industry, Council of the European Union, European Parliament, OECD, World Health Organization, and standardization alliances such as ISO/TMB. The standard is referenced in guidance produced by academic institutions like Massachusetts Institute of Technology, Stanford University, University of Cambridge, ETH Zurich, Delft University of Technology, and professional societies including ASME, IEEE, and CIE to align engineering curricula and research with contemporary safety practice.

Category:International standards