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Hoʻomaʻamaʻa ʻo Hitec Medical MDR - Hoʻohālikelike huahana ma lalo o MDR（Māhele 2）

Rula 10. ʻO nā mea hana diagnostic a me ka hoʻāʻo

Nā lako i hoʻohana ʻia no ka hoʻomālamalama ʻana (nā kukui hoʻokolokolo, microscopes surgical) Papa I；

No ke kiʻi kiʻi ʻana i nā radiopharmaceuticals i loko o ke kino (gamma camera) a i ʻole no ka ʻike pololei ʻana a i ʻole ka ʻike ʻana i nā kaʻina physiological koʻikoʻi (electrocardiogram, motor lolo, mea hana ana i ke koko uila) Class IIa；

Hoʻohana ʻia no ka nānā ʻana i nā hana physiological i nā kūlana pōʻino (nā mea loiloi koko i ka wā o ka ʻoki ʻana) a i ʻole ka hoʻokuʻu ʻana i ka radiation ionizing a hoʻohana ʻia no ka maʻi a i ʻole ka mālama ʻana (X-ray diagnostic machines,) Class IIb.

Rula 11. Hoʻohana ʻia nā lako polokalamu no ka hāʻawi ʻana i ka ʻike hoʻoholo no ka hana diagnostic a i ʻole ka lāʻau lapaʻau Papa IIa

Rula 12. Nā mea hana e hoʻomalu i ke komo ʻana a me ka puka ʻana o nā lāʻau lapaʻau a i ʻole nā ​​​​mea ʻē aʻe i loko o ke kino kanaka Class IIa (aspirators, supply pumps)

E like me ka hana ʻana ma kahi ʻano pōʻino (narcotics, ventilators, dialysis machines) Class IIb

Rula 13. No ka Papa I na laau lapaau e ae a pau

E like me: kukui nānā, noho niho, noho huila uila, moe uila

SpilikinoRules

Rula 14. Nā mea hana i loaʻa nā lāʻau kōkua a me nā unuhi koko kanaka ma ke ʻano he papa III

E like me: nā iwi lāʻau lāʻau sima, nā mea lāʻau lapaʻau aʻa i loko o ka lāʻau antibiotic, nā catheters i uhi ʻia me nā anticoagulants

Rula 15, lako hoʻolālā ʻohana

ʻO nā mea hana a pau i hoʻohana ʻia no ka hoʻopaʻa ʻana a i ʻole ke pale ʻana i ka lawe ʻia ʻana o nā maʻi i lawe ʻia i ke kāne (contraceptives) Class IIb;

Hiki ke hoʻokomo ʻia a i ʻole ka lōʻihi o ka hoʻoulu ʻana i nā mea hoʻopiʻi (mau mea hoʻohui i ka tubal) Papa III

Rula 16. Hoʻomaʻemaʻe ʻia a hoʻomaʻemaʻe ʻia paha

ʻO nā mea hana a pau i hoʻohana wale ʻia no ka disinfection a i ʻole ka disinfection ua helu ʻia ʻo Class IIa;

ʻO nā mea hana a pau i hoʻolālā ʻia no ka disinfection, hoʻomaʻemaʻe, a me ka holoi ʻana i nā lens contact hydrated ua helu ʻia ʻo Class IIb.

Rula 17. Nā lako no ka hoʻopaʻa ʻana i nā kiʻi diagnostic X-ray Class IIa

Rula 18, nā mea hana i hana ʻia mai nā ʻiʻo, nā cell a i ʻole nā ​​​​mea i loaʻa mai ke kumu kanaka a holoholona paha, Papa III

E like me nā kiwi puʻuwai ola kino i loaʻa i ka holoholona, ​​nā lole xenograft, nā mea hoʻopiha dermal collagen.

Rula 19. ʻO nā mea hana a pau e hoʻokomo a i ʻole nā ​​mea nano

me ka hiki no ke kiʻekiʻe a i ʻole ka haʻahaʻa o loko (nā nanomaterials hoʻopiha iwi hoʻohaʻahaʻa) Papa III;

Ka hōʻike ʻana i ka hiki haʻahaʻa o ka ʻike i loko (nā wili hoʻopaʻa iwi i uhi ʻia i ka nano) Papa IIb;

Hōʻike i ka hiki ʻole o ka ʻike i loko (nā lako hoʻopiha niho, nā nanopolymers hiki ʻole ke hoʻohaʻahaʻa ʻia) Papa IIa

Rula 20. ʻO nā mea hoʻomake i manaʻo ʻia e hāʻawi i nā lāʻau ma ka inhalation

ʻO nā mea hana invasive a pau e pili ana i nā puka o ke kino (nā mea hoʻomake no ka hoʻololi pani nicotine) Papa IIa;

Inā ʻaʻole he hopena koʻikoʻi ke ʻano o ka hana i ka hopena a me ka palekana o ka lāʻau lapaʻau i lawelawe ʻia a me nā mea i manaʻo ʻia no ka mālama ʻana i nā kūlana weliweli i ke ola Class II b

Rula 21. Nā mea hana i hoʻokomo ʻia ma ka puka o ke kino a i hoʻopili ʻia i ka ʻili.

Inā komo lākou, a i ʻole kā lākou metabolites, i loko o ka ʻōpū a i ʻole ka ʻāpana ʻōpū o lalo a i ʻole ka ʻōnaehana kino, ua hoʻokō ʻia ke kumu (sodium alginate, xyloglucan) Papa III;

Hoʻopili ʻia i ka ʻili, ka ihu, a me ka waha waha ma luna o ka pharynx a e hoʻokō i ko lākou manaʻo i loko o kēia mau lua (nā nasal and nasal sprays,) Class IIa;

Ma nā hihia ʻē aʻe a pau (oral activated coal, hydrated eye drops) Class IIb

Rula 22. ʻO nā lako lapaʻau ikaika me nā mana diagnostic i hoʻohui ʻia

ʻO nā mea lapaʻau ikaika (nā ʻōnaehana hāʻawi insulin i pani ʻia, nā defibrillator waho waho) me nā hana diagnostic i hoʻohui ʻia a i hui pū ʻia ʻo ia ke kumu nui o ka mālama ʻana i ka maʻi me ka hāmeʻa (automated external defibrillators) Class III