He kaihanga a TRIANGEL, ehara i te takawaenga
1. Hekaihanga ngaio o ngā taputapu laser hauora, kua whiwhi tā mātou endolaser me te roangaru rua 980nm 1470nm i te US Food and Drug Administration (FDAte tiwhikete hua taputapu hauora a).
✅Ko te Whakahaere Kai me te Rongoā (FDA) te tinana o Amerika e kawenga ana mō te tiaki i te hauora o te marea, me te whakarite i te haumaru o ngā momo hua rerekē pēnei i ngā rongoā, ngā hua kai, ngā taputapu hauora, ngā mea whakapaipai, me ngā hua e tuku ana i te hihi, (...). Ka whakatūpato hoki te FDA i ngā tohunga hauora me te marea (mēnā e tika ana) ina puta he raruraru ki ngā taputapu hei whakarite i tō rātou whakamahinga tika me te hauora me te haumaru o ngā tūroro.
Kua whakamanahia e te FDA tā mātou taputapu taiaho me ngā roangaru rua 980nm 1470nm, e whakamana ana i te kounga me te pono o ngā hua TRIANGEL puta noa i te ao.
2. Ko tā mātou mahi whakaputa me te hanga he tino rite ki te pūnaha whakahaere kounga taputapu hauora o Haina meISO13485(ehara i te ISO9001, ehara te 9001 i te pūnaha whakahaere ā-ture) pūnaha kounga taputapu hauora, ā, kua whakapau kaha mātou ki te whakarato i ngā hua ture, tutuki i ngā whakaritenga, haumaru me te whai hua ki ngā kaiwhakamahi.
✅He taputapu nui ngā tiwhikete ISO hei whakaatu i te tutuki o ngā pūnaha whakahaere tukanga pakihi ki ngā paerewa kua tautuhia e ngā paerewa hangarau.
��️ Engari, ko te ISO 13485 he tiwhikete kounga e pā ana ki ngā taputapu hauora anake, e ai ki ngā whakaritenga me ngā ture o te Kotahitanga o Ūropi. E whakamana ana i te kaha o tētahi kamupene ki te whakarato taputapu hauora me ngā ratonga e pā ana e tutuki ana i ngā whakaritenga a te kiritaki me ngā ture whakahau.
3. He mea nui te haumaru mō tātou. I ia rā, ka hikoi mātou i te huarahi ki te haumaru o ā mātou taputapu, me te whakaute i ngā tiwhikete e hiahiatia ana e ngā ture mō ngā taputapu hiko-hauora. Ko te whakarāpopototanga CE e tohu ana i te "European Conformity" ā, e tohu ana i te tutuki i te ture haumaru a te EU. Mā tēnei ka whakarite kua paahitia e te hua ngā whakamātautau motuhake, ā, nō reira, ka taea te tohatoha ki ngā wāhi katoa i roto i te Kotahitanga o Europi me te Rohe Ōhanga o Europi.
He aha tāu e tumanako ai mai i Triangel?
1. Nō te USA ngā wāhanga matua o tā mātou mīhini, he mārama rawa ngā paerewa me ngā whakaritenga mō ngā wāhanga me ngā rauemi katoa o ngā taputapu hauora. Me tutuki ngā wāhanga matua pēnei i ngā pūhiko whakawhiti hiko, ngā pana aukati ohorere, ngā pana matua, ngā reera, me ētahi atu ki ngā paerewa hauora. Kāore e hiahiatia kia tutuki i ngā taputapu reera whānui ēnei paerewa uaua, nō reira he iti ake te utu.
2. Te whakangungu haumanu me te tautoko
He nui ā mātou kaituku, tākuta me ngā ahorangi haumanu huri noa i teao, mā tēnei ka whakarite kia nui ake āu hua ina hoko koe i ngā hua TRIANGELngā otinga haumanu, ngā tukanga me te tautoko hangarau, kia maeneene ake ai tō pokanga, kiawhai hua ake.
3. Pūtāhui me te Whai muri i te hoko
E ai ki te whakaritenga o te taputapu hauora, kāore e iti iho i te 5-8 tau te roa o te ora o te hua.I roto i te wā whakamana 18 marama, ki te kore e pakaruhia e ngā āhuatanga tangata, ka whakaratohia e tā mātou kamupene he ratonga muri-hoko kore utu.
Wā tuku: Maehe-12-2025