ISO Withdraws Machinery Risk Assessment Standards

This entry is part 1 of 8 in the series Risk Assessment

ISO has withdrawn three long-standing basic machinery safety standards used internationally and in the EU and replaced them with a single combined document. If you design, build or integrate machinery for sale internationally or within the EU, this new standard needs to be on your BUY list!

ISO 14121-1 Withdrawn, along with ISO 12100-1 and -2

As of 20-Oct-2010 three standards, ISO 14121-1, Safety of Machinery – Risk Assessment – Part 1: Principles, ISO 12100-1, Safety of machinery – Basic concepts, general principles for design – Part 1: Basic terminology and methodology and ISO 12100-2, Safety of machinery – Basic concepts, general principles for design – Part 2: Technical principles, have been replaced by the new ISO 12100:2010, Safety of machinery — General principles for design — Risk assessment and risk reduction blends together three fundamental Type A machinery standards into one coherent whole. This important new document means that machinery designers have the fundamental design requirements for all machinery in one standard. The only exception is now ISO/TR 14121-2:2007, Safety of machinery — Risk assessment — Part 2: Practical guidance and examples of methods. This Technical Report stands as guidance for risk assessment and provides a number of examples of the different methods used to assess machinery risk.


This abstract is taken from the ISO web catalog page for the new standard.

ISO 12100:2010 specifies basic terminology, principles and a methodology for achieving safety in the design of machinery. It specifies principles of risk assessment and risk reduction to help designers in achieving this objective. These principles are based on knowledge and experience of the design, use, incidents, accidents and risks associated with machinery. Procedures are described for identifying hazards and estimating and evaluating risks during relevant phases of the machine life cycle, and for the elimination of hazards or sufficient risk reduction. Guidance is given on the documentation and verification of the risk assessment and risk reduction process.

ISO 12100:2010 is also intended to be used as a basis for the preparation of type-B or type-C safety standards.

It does not deal with risk and/or damage to domestic animals, property or the environment.

Table of Contents

Here is the table of contents from the standard as published.



1 Scope

2 Normative references

3 Terms and definitions

4 Strategy for risk assessment and risk reduction

5 Risk assessment

5.1 General

5.2 Information for risk assessment

5.3 Determination of limits of machinery

5.3.1 General

5.3.2 Use limits

5.3.3 Space limits

5.3.4 Time limits

5.3.5 Other limits

5.4 Hazard identification

5.5 Risk estimation

5.5.1 General

5.5.2 Elements of risk

5.5.3 Aspects to be considered during risk estimation

5.6 Risk evaluation

5.6.1 General

5.6.2 Adequate risk reduction

5.6.3 Comparison of risks

6 Risk reduction

6.1 General

6.2 Inherently safe design measures

6.2.1 General

6.2.2 Consideration of geometrical factors and physical aspects

6.2.3 Taking into account general technical knowledge of machine design

6.2.4 Choice of appropriate technology

6.2.5 Applying principle of positive mechanical action

6.2.6 Provisions for stability

6.2.7 Provisions for maintainability

6.2.8 Observing ergonomic principles

6.2.9 Electrical hazards

6.2.10 Pneumatic and hydraulic hazards

6.2.11Applying inherently safe design measures to control systems

6.2.12 Minimizing probability of failure of safety functions

6.2.13 Limiting exposure to hazards through reliability of equipment

6.2.14 Limiting exposure to hazards through mechanization or automation of loading (feeding) / unloading (removal) operations

6.2.15 Limiting exposure to hazards through location of setting and maintenance points outside danger zones

6.3 Safeguarding and complementary protective measures

6.3.1 General

6.3.2 Selection and implementation of guards and protective devices

6.3.3 Requirements for design of guards and protective devices

6.3.4 Safeguarding to reduce emissions

6.3.5 Complementary protective measures

6.4 Information for use

6.4.1 General requirements

6.4.2 Location and nature of information for use

6.4.3 Signals and warning devices

6.4.4 Markings, signs (pictograms) and written warnings

6.4.5 Accompanying documents (in particular – instruction handbook)

7 Documentation of risk assessment and risk reduction

Annex A (informative) Schematic representation of a machine

Annex B (informative) Examples of hazards, hazardous situations and hazardous events

Annex C (informative) Trilingual lookup and index of specific terms and expressions used in ISO 12100


Buying Advice

This is a significant change in these three standards. Revision to the text of the standards was significant. at least from the perspective that the material has been re-organized into a single, coherent document. If you are basing a CE Mark on these standards, you should strongly consider purchasing the harmonized version when it becomes available at your favourite retailer. The ISO version is available now in English and French as a hard copy or pdf document, priced at 180 CHF (Swiss Francs), or about CA$175.

As of this writing CEN has adopted EN ISO 12100:2010, with a published “dow” (date of withdrawal) of 30-Nov-2013. The “doc” (date of cessation) will be published in a future list of harmonized standards in the Official Journal of the European Union under the Machinery Directive 2006/42/EC.

My recommendation is to BUY this standard if you are a machine builder. If you are CE marking your product you may want to wait until the harmonized edition is published, however it is worth knowing that technical changes to the normative content of the standard are very unlikely when harmonization occurs.

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Author: Doug Nix

+DougNix is Managing Director and Principal Consultant at Compliance InSight Consulting, Inc. ( in Kitchener, Ontario, and is Lead Author and Managing Editor of the Machinery Safety 101 blog.

Doug's work includes teaching machinery risk assessment techniques privately and through Conestoga College Institute of Technology and Advanced Learning in Kitchener, Ontario, as well as providing technical services and training programs to clients related to risk assessment, industrial machinery safety, safety-related control system integration and reliability, laser safety and regulatory conformity.

  • Morgan Foley

    What will happen to ISO 14121-2:2007 TR?

    • Morgan,

      This is a good question. At the moment ISO/TR 14121-2 remains a published technical report. In my experience, ISO does not like to incorporate guidance information into their standards, preferring to keep it separately as Technical Reports. My best guess is that this TR will remain until at least the end of the next revision cycle in 2012. The TC may choose to re-approve the document as it stands for another 5 years, revise it and publish a new edition or withdraw it at that time. If you know anyone who sits on ISO TC199 you may be able to get some additional insight into the future of this document through that channel. If I hear anything I will certainly post it here!

  • Thanks Roberta for your comment. I think the biggest changes are in the reorganization of the material, along with some more minor edits to make the material flow together.

    In my opinion, the blending together of these three important standards is a positive step forward, and it has the additional bonus of saving buyers money over purchasing three standards.

  • Roberta Nelson Shea

    There should be NO significant changes to the new ISO 12100. This new document’s scope was to ONLY combine ISO 12100-1, 12100-2, and 14121. The committee scope specifically did not allow any technical changes. However as we all know, sometimes even editorial changes convey a different meaning even though there are no technical changes. I am in the process of reading the new document so I have yet to compare it to the other standards to determine if there are any technical changes.