ISO Withdraws Machinery Risk Assessment Standards

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ISO 14121–1 Withdrawn, along with ISO 12100–1 and -2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Safe­ty of machin­ery – Basic con­cepts, gen­er­al prin­ci­ples for design – Part 2: Tech­ni­cal prin­ci­ples, have been replaced by the new ISO 12100:2010, Safe­ty of machin­ery — Gen­er­al prin­ci­ples for design — Risk assess­ment and risk reduc­tion blends togeth­er three fun­da­men­tal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

Series Nav­i­ga­tionHow Risk Assess­ment Fails

Author: Doug Nix

Doug Nix is Managing Director and Principal Consultant at Compliance InSight Consulting, Inc. ( in Kitchener, Ontario, and is Lead Author and Senior 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. For more see Doug's LinkedIn profile.