Product standard EN 60601–1‑2 Ed.4

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.

• 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.

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.