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ISO Withdraws Machinery Risk Assessment Standards

2010 November 19
by Doug Nix
This entry is part 1 of 7 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ISO 14121–1 Withdrawn, along with ISO 12100–1 and –2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Safety of machin­ery – Basic con­cepts, gen­eral prin­ci­ples for design – Part 2: Technical prin­ci­ples, have been replaced by the new ISO 12100:2010, Safety of machin­ery — General prin­ci­ples for design — Risk assess­ment and risk reduc­tion blends together three fun­da­men­tal Type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.

Post By Doug Nix (95 Posts)

+DougNix is Managing Director and Principal Consultant at Compliance InSight Consulting, Inc. (http://​www​.com​pli​an​cein​sight​.ca) 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.

Website: → Compliance inSight Consulting Inc.


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  • Morgan Foley

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

    • Doug Nix


      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!

  • Doug Nix

    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.

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