Product standard EN 60601–1‑2 Ed.4

Produktnorm EMV 60601-1-1 Edition 4

ELECTROMAGNETIC INTERFERENCE RESISTANCE

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

UNCONDITIONAL SAFETY WITH CONTROL SOLUTIONS FROM GETT

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:

Siegel

Cleantype® Prime Touch+

A desk­top sil­i­cone key­board with a touch pad and suit­able for med­ical use NEW!

Prod­uct details

Cleantype® Prime Pro+

A desk­top sil­i­cone key­board with a full lay­out and suit­able for med­ical use NEW!

Prod­uct details

CK5 Cleankeys® keyboard with a touch surface

Smart Design. Top Hygiene. NEW!

Prod­uct details

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 Classic

InduProof® Smart Clas­sic — Clean­able sil­i­cone key­board
for med­ical envi­ron­ment

Prod­uct details

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