Ibipimo by'ibimuga by'amashanyarazi bigomba kubahiriza mubucuruzi mpuzamahanga

Ibipimo by'ibimuga by'amashanyarazi bigomba kubahiriza mubucuruzi mpuzamahanga
Nkigikoresho cyingenzi gifasha gusubiza mu buzima busanzwe, amagare y’ibimuga afite uruhare runini mu bucuruzi mpuzamahanga. Mu rwego rwo kurinda umutekano, gukora neza no kubahiriza intebe z’ibimuga by’amashanyarazi, ibihugu n’uturere byashyizeho urutonde rw’ibipimo ngenderwaho. Ibikurikira nibyo bipimo nyamukuru ibyoibimuga by'amashanyarazibakeneye kubahiriza ubucuruzi mpuzamahanga:

1. Ibipimo by’isoko ry’ibihugu by’Uburayi
Amabwiriza y’ibikoresho by’ubuvuzi bya EU (MDR)
Intebe y’ibimuga y’amashanyarazi ishyirwa mu bikoresho by’ubuvuzi byo mu cyiciro cya mbere ku isoko ry’Uburayi. Dukurikije amabwiriza y’ubumwe bw’ibihugu by’Uburayi (EU) 2017/745, amagare y’ibimuga yoherezwa mu bihugu bigize Umuryango w’ubumwe bw’ibihugu by’Uburayi agomba kuba yujuje ibi bikurikira:

Uhagarariye Umuryango w’ubumwe bw’ibihugu by’Uburayi: Hitamo uhagarariye Umuryango w’ubumwe bw’ibihugu by’Uburayi wemewe kugira ngo ufashe ababikora mu buryo bwihuse kandi neza gukemura ibibazo bitandukanye.
Kwiyandikisha ku bicuruzwa: Tanga icyifuzo cyo kwandikisha ibicuruzwa mu bihugu bigize uyu muryango uhagarariye Umuryango w’ubumwe bw’ibihugu by’Uburayi kandi wuzuze ibaruwa yo kwiyandikisha.
Inyandiko ya tekiniki ya MDR: Tegura inyandiko tekinike ya CE yujuje ibisabwa n'amabwiriza ya MDR. Muri icyo gihe, inyandiko za tekiniki nazo zigomba kubikwa nuhagarariye Umuryango w’ubumwe bw’ibihugu by’Uburayi kugira ngo zigenzurwe neza.
Itangazo ryuzuzanya (DOC): Intebe z’ibimuga ni ibikoresho byo mu cyiciro cya mbere, kandi birasabwa kandi kwerekana ko bihuye.
Ibipimo by'ibizamini
EN 12183: Irakoreshwa ku ntebe y’ibimuga ifite umutwaro utarenze 250 kg hamwe n’intebe y’ibimuga ifite ibikoresho bifasha amashanyarazi
EN 12184: Bikoreshwa ku ntebe y’ibimuga ifite umuvuduko ntarengwa utarenze 15 km / h no gutwara imwe n'umutwaro utarenze kg 300

2. Ibipimo byo kugera ku isoko muri Amerika
Icyemezo cya FDA 510 (k)
Intebe z’ibimuga by’amashanyarazi zashyizwe mu byiciro by’ubuvuzi byo mu cyiciro cya kabiri muri Amerika. Kugira ngo winjire ku isoko ry’Amerika, ugomba kohereza FDA 510K inyandiko hanyuma ukemera isuzuma rya tekiniki rya FDA. Ihame rya 510K ya FDA ni ukugaragaza ko ibikoresho byubuvuzi byatangajwe bihwanye cyane nigikoresho cyagurishijwe byemewe n'amategeko muri Amerika.

Ibindi bisabwa
Icyemezo cyo kwiyandikisha: Intebe z’ibimuga zoherejwe muri Amerika nazo zigomba gutanga icyemezo cyo kwiyandikisha.
Igitabo cy'umusaruro: Tanga igitabo kirambuye.
Uruhushya rwo gukora: Uruhushya rwo gukora rugaragaza ko inzira yumusaruro yubahiriza amabwiriza.
Kugenzura ubuziranenge bwanditse: Erekana inyandiko zigenzura ubuziranenge bwibicuruzwa.
Raporo yo kugenzura ibicuruzwa: Tanga raporo yo kugenzura ibicuruzwa kugirango ugaragaze ubuziranenge bwibicuruzwa

3. Ibipimo by’isoko ry’Ubwongereza
Icyemezo cya UKCA
Intebe z’ibimuga zoherejwe mu Bwongereza n’ibikoresho by’ubuvuzi byo mu cyiciro cya mbere ukurikije ibisabwa n’amabwiriza y’ubuvuzi UKMDR2002 kandi bakeneye gusaba icyemezo cya UKCA. Nyuma yitariki ya 30 Kamena 2023, ibikoresho byubuvuzi byo mu cyiciro cya mbere bigomba gushyirwaho ikimenyetso cya UKCA mbere yuko byoherezwa mu Bwongereza.

Ibisabwa
Kugaragaza UKRP idasanzwe: Ababikora bakeneye kwerekana umuntu udasanzwe w’Ubwongereza Ushinzwe (UKRP).
Kwandikisha ibicuruzwa: UKRP yarangije kwandikisha ibicuruzwa hamwe na MHRA.
Inyandiko za tekiniki: Hano hari inyandiko tekinike ya CE cyangwa inyandiko ya tekiniki ya UKCA yujuje ibisabwa.

4. Amahame mpuzamahanga
ISO 13485
ISO 13485 ni amahame mpuzamahanga ya sisitemu yo gucunga neza ibikoresho byubuvuzi. Nubwo atari ibisabwa mu buryo butaziguye kugira ngo umuntu agere ku isoko, itanga ubwishingizi bufite ireme bwo gushushanya no gukora ibikoresho by’ubuvuzi.

Umwanzuro
Intebe z’ibimuga zikoresha amashanyarazi zigomba kubahiriza amahame n’amabwiriza akomeye mu bucuruzi mpuzamahanga kugira ngo umutekano w’ibicuruzwa bikorwe neza. Ababikora bagomba gusobanukirwa nibisabwa kugirango isoko ryerekanwe kandi barebe ko ibicuruzwa byabo byujuje ubuziranenge bwibizamini hamwe nibisobanuro bya tekiniki. Mugukurikiza aya mahame, amagare y’ibimuga arashobora kwinjira neza ku isoko mpuzamahanga kandi agatanga ibikoresho byifashishwa mu gusubiza mu buzima busanzwe abakoresha isi yose.