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ISO 12100:2010 Safety Of Machinery-Design Risk Assessment & Reduction

According to the WTO/TBT Agreement of 1995, member nations are required to create standards, such as compulsory standards, voluntary standards and conformance assessment processes, by integrating said standards with international standards—like the ISO and IEC standards. Facilities and machines conform to ISO/IEC standards. This makes it possible to, in general instances, make these facilities and machines conform to the technical criteria of various countries in order to increase unity around the world. Thus, allowing for fewer restrictions to worldwide trade.

Key Requirements:
SO 12100:2010 (ISO 12100) specifies basic terminology, codes and a methodology for achieving safety in the design of machinery. It stipulates principles of risk assessment and risk reduction to aid designers in reaching this objective. These principles are grounded on information and experience of the design, use, incidents, accidents and risks related to machinery.

Within the standard, procedures are defined for identifying hazards; approximating and evaluating risks throughout relevant stages of the machine life cycle; and for the elimination of hazards or sufficient risk reduction. Direction is provided on the documentation and verification of the risk assessment and risk-reduction process. ISO 12100:2010 is additionally intended to be utilized as a base for the preparation of type-B or type-C safety standards. It doesn’t contract with risk and/or damage to domestic animals, property or the environment.

Why the Standard is Important:
he ISO 12100 standard substitutes ISO 12100-1:2003, ISO 12100-2:2003 and ISO 141211:2007. The new standard will benefit designers who identify risks during the design stage of machine production, decreasing the potential for accidents.

The risk assessment procedures provided in ISO 12100 are offered as a series of logical steps, helping designers to methodically define the limits of the machinery; identify risks of hazards such as crushing, cutting, electric shock or fatigue; and  estimate potential dangers, fluctuating from machine failure to human error.

By providing a best practices framework at the international level, ISO 12100 will help eradicate technical barriers to trade, while at the same time upholding the safety and health of users of machinery, in line with necessities of national legislations of countries around the world. This is an especially important standard for machine builders.

Differences Between ISO and ANSI Standard:
Before a manufacturer can reap the benefits of safety practices, they need to understand which machine standards to follow. In terms of performing a risk assessment, the international standard ISO 12100:2010, and the North American standard ANSI B11.0-2010 are similar in many ways, but they also differ.

ANSI B11.0 is a significant document for machinery safety and for the safety of end-users. The scope of the standard focuses on new, modified or rebuilt power-driven machines, not portable-by-hand, used-to-shape and/or form metal, or other materials by cutting, impact, pressure, electrical or other processing techniques, or a combination of these processes. The ISO 12100 standard is geared more toward original equipment manufacturers (OEMs), while ANSI B11.0 covers not only machine builders, but also end-users.

This means there may be some subtle terminology in ANSI B11.0 geared for end-users that may not have a direct correlation with the ISO standards. Other than that, the risk assessment principals and requirements documentation are almost the same for both standards.

The ANSI B11.0 standard references the similarities between the two:

“This standard has been harmonized with international (ISO) and European (EN) standards by the introduction of hazard identification and risk assessment as the principal method for analyzing hazards to personnel to achieve a level of acceptable risk. This standard integrates the requirements of ANSI/ISO 12100 parts 1 and 2, and ISO 14121 (now combined into a single standard–ISO 12100), as well as selected U.S. standards. Suppliers meeting the requirements of this ANSI B11.0  standard may simultaneously meet the requirements of these ISO standards.”

There is an equivalency between the two standards. If a builder designs a machine to ANSI B11.0 and ships it to Europe or any non-North American country, it would, for all practical purposes, have met ISO 12100 or EN ISO 12100 requirements because of the harmonization. The same is true for machines built offshore that meet ISO 12100 specifications before being shipped to North America. Both standards are globally recognized.

Compliance Assistance:
Designers who are interested in purchasing the full guide for ISO 12100:2010 Safety Of Machinery – General Principles for Design – Risk Assessment And Risk Reduction Standard can visit:

SPONSORED BY: American National Standards Institute
“Moving parts, extreme temperatures, constant noise and sharp edges comprise only a few of the hazards innate to machinery. Accidents involving machinery incur high costs, both in human terms and also economic and societal ones. Helping to assure the safety and health of consumers is a key component of ANSI’s goal. Vast reduction of injury can be accomplished by considering safety hazards from the initial concept and design of machinery. ISO 12100 Safety of Machinery-General Principals for Design-Risk Assessment and Risk Reduction, available through ANSI, establishes basic terminology, and is used to aid in decision-making through the design process.” – Julie Wallace, Sr. Product Manager, American National Standards Institute (ANSI) American National Standards Institute, 212-642-4900,

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