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ISO 14121 – 1 Withdrawn, along with ISO 12100 – 1 and -2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– 2, Safety of machinery – Basic con­cepts, gen­er­al prin­ciples for design – Part 2: Technical prin­ciples, have been replaced by the new ISO 12100:2010, Safety of machinery – General prin­ciples for design – Risk assess­ment and risk reduc­tion blends togeth­er three fun­da­ment­al Type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.

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  • 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.