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ISO Withdraws Machinery Risk Assessment Standards

This entry is part 1 of 9 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ISO 14121 – 1 Withdrawn, along with ISO 12100 – 1 and -2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– 2, Safety of machinery – Basic con­cepts, gen­er­al prin­ciples for design – Part 2: Tech­nic­al prin­ciples, have been replaced by the new ISO 12100:2010, Safety of machinery – Gen­er­al prin­ciples for design – Risk assess­ment and risk reduc­tion blends togeth­er three fun­da­ment­al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 cata­logue 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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