I te mea kei te piki haere tonu te hiahia o te ao mō ngā taputapu hauora kore utu kounga teitei, kei te whakapakari ake ngā whakahaere ture i Ūropi me te Hononga o Amerika i ngā whakaritenga ture—ina koa mō ngā ngira me ngā taputapu kohikohi toto. Kei te tirotirohia haeretia ēnei taputapu hauora nui nā te mea he whānui te whakamahinga i roto i ngā tātaritanga, ngā werohanga, me te tiaki tūroro.
Mō ngā kaihanga, ngā kaikawemai, me ngā kaituku, ko te mārama ki ēnei paerewa e whanake haere ana ehara i te mea ko te whakatutuki i ngā whakaritenga ture anake—he mea nui ia hei whakarite i te haumaru o ngā hua, hei whakapai ake i te urunga atu ki te mākete, me te hanga i te mana pumau mō te wā roa.
Arotahi Kaha ki te Haumaru me te Whai Aroturuki
I roto i te Kotahitanga o Ūropi me te Hononga o Amerika, ko te haumaru o te tūroro te kaupapa matua mō ngā huringa ture hou. Hei tauira, ko te Ture Pūrere Hauora (MDR) a te EU, i whakakapi katoa i te MDD o mua i te tau 2021, e aro nui ana ki ngā aromatawai haumanu whānui, ngā aromatawai mōrearea, me te tirotiro i muri i te mākete.
I te US, ko te Wāhanga 820 (Whakahaere Pūnaha Kounga) 21 CFR a te FDA kei te noho tonu hei tūāpapa mō ngā paerewa hanga. Heoi anō, ko ngā whakahoutanga e haere ake nei e hangai ana ki te ISO 13485 ka aro nui ki te whai i ngā hua me te tuhi tuhinga—ina koa mō ngā taputapu Akomanga II pērā i ngā weronga me ngā ngongo kohi toto.
He aha te tikanga o tēnei mō ngā kaiwhakarato? Me taea te whai me te manatoko i ia wāhanga o te mekameka tuku—mai i te kōwhiringa rauemi mata ki te takai.
Te Arotahi ki te Hototahitanga Koiora me te Whakapūmautanga o te Paiherekore
I te mea kei te piki haere ngā āwangawanga mō ngā tauhohenga a ngā tūroro me ngā mōrearea poke, kāore e taea te whakamātau i te hototahitanga koiora. Me whakamātau hōhonu ngā kaiwhakahaere o Ūropi me Amerika i raro i ngā paerewa ISO 10993 hei whakaū i te haumaru o ngā rauemi e whakamahia ana i roto i ngā ngira, ngā rakete, me ngā ngongo mō te pa atu ki te tangata.
Hei tāpiritanga, me tutuki i ngā tukanga whakahoromata (pēnei i te ethylene oxide, te gamma irradiation rānei) ngā whakaritenga whakamana kua whakarārangihia i roto i te ISO 11135, ISO 11137 rānei. He mea tino nui te whakapūmau i te whakahoromata mō ngā hua kua whakakīia i mua, kua whakamahia rānei hei kohi toto tika.
Ki ngā kaihoko hauora me ngā kawemai, ko te tikanga he mea nui ake i mua te whiriwhiri i ngā kaiwhakarato ka taea te whakarato i ngā pūrongo mō te kore tamariki kua tuhia me ngā tikanga kua whakamanahia.
Ngā Rauemi e Mōhio Ana ki te Taiao me ngā Whakaritenga Takai Tauwhiro
I ngā tau tata nei, kua neke te oranga tonutanga mai i te karere hokohoko ki te tumanako ture. Kei te kaha te EU ki te whakatenatena i te whakaiti i ngā kirihou kotahi te whakamahinga me ngā matū kino ki te taiao. Ahakoa he maha ngā wā ka whakakorehia ngā hua hauora i te aukati, kei te piki haere te pēhanga ki te whakamahi i ngā rauemi hangarua, ngā rauemi koiora rānei i ngā wāhi katoa e taea ai.
Waihoki, ko te mākete o Amerika—ina koa i roto i ngā whatunga hokohoko hauora nui—kei te piki haere te arotakenga o ngā hua i runga i ō rātou tapuwae taiao. Ko ngā takai e whakaiti ana i te para, ngā taputapu rānei i hangaia mai i ngā rauemi kore-BPA me te kore-DEHP, kei te piki haere te rongonui.
Mō ngā kaihanga o ngā taputapu kohikohi toto me ngā ngira, mā te urutau ki ēnei tumanakohanga ehara i te mea ka tutuki noa i ngā whakaritenga—engari ka whakarei ake hoki i te whakataetae.
Te Hiranga o te Tapanga Tika me te Whakatutukitanga UDI
Kei te kaha te aukati a ngā whakahaere ture i te tika o ngā tapanga. E hiahiatia ana e te EU MDR me te US FDA kia mārama te tānga o ngā Tautuhi Pūrere Ahurei (UDI), ngā rā paunga, ngā tau puranga, me te reo e whakamahia ana mō ngā mākete e hokona ana.
Ki te kore e tutuki i ēnei paerewa, ka hua ake he whakaroa i ngā tikanga tuku iho, he whakahokinga mai i ngā taonga, he ngaronga rānei o te urunga atu ki te mākete. He mea nui te whiriwhiri i tētahi tukanga tākai me te tapanga e tautoko ana i ngā whakaritenga tapanga ture hei whakarite i te maeneene o ngā mahi kawemai/kaweake.
Te Whakatere i ngā Ture me te Māia
Ko te whakatere i roto i te taiao ture matatini o Ūropi me te US e hiahia ana kia nui atu i te hanganga ture taketake anake—e hiahia ana kia whakarite wawe, kia whakamana tonu i te hua, me te aro nui ki ngā au hou.
Ki ngā kaihoko, ki ngā kaihokohoko mai, me ngā kaiwhakarato hauora, he mea nui te noho mōhio ki ngā ture hou mō ngā ngira me ngā taputapu kohikohi toto hei whakatau whakaaro nui ki te hoko mai.
Kei te hiahia koe ki te whakarite kia tutuki i ō hua hauora whakakorekore ngā paerewa ture o te ao? Whakapā atu ki a Sinomed i tēnei rā, tirohia me pēhea te tautoko a ā mātou otinga i ō whāinga tutuki ture me te kounga.
Wā tuku: Pipiri-23-2025
