Pro­duct stan­dard EN 60601-1-2 Ed.4

Produktnorm EMV 60601-1-1 Edition 4


It is par­ti­cu­lar­ly important in medi­cal are­as, such as doc­tors’ prac­tices and cli­nics, that medi­cal tech­no­lo­gy pro­duc­ts are pro­tec­ted against mal­func­tions and fail­u­res cau­sed by elec­tri­cal emis­si­ons. Con­ver­se­ly, elec­tri­cal devices must not be allo­wed to nega­tively influ­ence their envi­ron­ment by emit­ting elec­tro­ma­gne­tic vibra­ti­ons. The European pro­duct stan­dard EN 60601-1-2 the­re­fo­re requi­res the “elec­tro­ma­gne­tic immu­ni­ty” of medi­cal devices. This not only pro­tec­ts the devices but can also save lives in an emer­gen­cy.

Which pro­duc­ts need to be cer­ti­fied accord­ing to this stan­dard?

Any pro­duc­ts, which are defi­ned as a “medi­cal pro­duct” or “medi­cal sys­tem” accord­ing to Sec­tion 3 of the Ger­man Medi­cal
Pro­duc­ts Act, need to be tested and cer­ti­fied accord­ing to EN 60601 or one of its par­ti­al stan­dards. Manu­fac­tu­rers can also cer­ti­fy their pro­duc­ts accord­ing to this stan­dard or one of its par­ti­al stan­dards on a vol­un­ta­ry basis, even if their items are not defi­ned as a medi­cal pro­duct.

What requi­re­ments does the stan­dard place on medi­cal pro­duc­ts?

• The types of elec­tro­ma­gne­tic inter­fe­rence that medi­cal pro­duc­ts have to cope with wit­hout any pro­blems;
• How much elec­tro­ma­gne­tic radia­ti­on medi­cal pro­duc­ts may emit;
• How the requi­re­ments in this respect may depend on the spe­ci­fic envi­ron­ment whe­re the unit is used and the risk emana­ting from the pro­duct;
• How it is necessa­ry to mea­su­re, test and docu­ment the­se mea­su­rements; and
• How the manu­fac­tu­rer must mark the pro­duct and which infor­ma­ti­on must be found in the ope­ra­ting inst­ruc­tions.

Why is the­re a new Edi­ti­on (4) of EN 60601-1-2?

The envi­ron­ments, whe­re medi­cal equip­ment is being used, are more com­plex now than ever befo­re. Tech­no­lo­gies are con­ti­nuing to deve­lop at a rapid pace and this makes it necessa­ry to per­man­ent­ly adapt the requi­re­ments that are sti­pu­la­ted in stan­dards. One of the most important new fea­tures in EN 60601-1-2 Edi­ti­on 4 is the stron­ger focus on “inten­ded usa­ge envi­ron­ments”, for which risk manage­ment is necessa­ry in each case, accord­ing to EN 4971 3. This descri­bes the increa­ses in requi­re­ments for pro­fes­sio­nal health care, for health care at home and for “spe­cial” envi­ron­ments. The tougher EMC test spe­ci­fi­ca­ti­ons in Edi­ti­on 4 are also desi­gned to ensu­re resis­tan­ce to inter­fe­rence in the rele­vant con­di­ti­ons.

Fur­ther infor­ma­ti­on


The EMV stan­dard does not yet come into force for key­boards and com­pu­ter mice. Howe­ver, the­se elec­tri­cal devices have beco­me an indis­pensable part of ever­y­day medi­cal life. We have the­re­fo­re deci­ded to test our input devices for the medi­cal sec­tor accord­ing to EMC cri­te­ria. The fol­lo­wing GETT pro­duc­ts meet the requi­re­ments of EN 60601-1-2-2:


Indu­Mou­se® Pro: Sili­­co­­ne-hygie­­­ne-mou­­se working on glass sur­faces

Water­pro­of and dust­pro­of sili­co­ne mou­se for use in hygie­ne-sen­si­ti­ve envi­ron­ments

Pro­duct details

Capa­ci­ti­ve Key­board Clean­keys® CK4W Wire­less

The easy-to-clean key­board

Pro­duct details

Capa­ci­ti­ve Key­board Clean­keys® CK4

Clean­keys® CK4 - Touch key­board with glass sur­face

Pro­duct details

Indu­pro­of® Smart Pro Illu­mi­na­ted

Indu­pro­of® Smart Pro - All-in-one key­board with illu­mi­na­ti­on, magne­tic moun­ting and IP68 pro­tec­tion

Pro­duct details

Indu­Pro­of Smart Clas­sic

Indu­Pro­of® Smart Clas­sic - Clean­ab­le sili­co­ne key­board
for medi­cal envi­ron­ment

Pro­duct details

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