Inaliti yokuqoqa igazi yokuphepha yohlobo lwepeni

Incazelo emfushane:

I-CE, i-ISO13485, ukuvunyelwa kwe-FDA

Osayizi abahlukene bayatholakala

I-OEM ne-ODM ziyatholakala

Sithumelele i-imeyili

Imininingwane Yomkhiqizo

Amathegi Omkhiqizo

Ukusetshenziswa Kwezinaliti Zokuqoqa Igazi

Inaliti yokuqoqwa kwegazi isetshenziswa ochwepheshe bezempilo ukubhoboza umthambo ngokuphephile nokukhipha igazi esigulini ukuze kuhlolwe ukuxilonga. Le nqubo ibalulekile ekutholeni amasampula egazi ukusiza ekuxilongeni nasekuqapheni izimo zezokwelapha. Inaliti ifakwa emthanjeni, bese igazi liqoqwa emapayipini akhethekile ukuze lihlaziywe. Indlela efanele ibalulekile ukuqinisekisa ukuphepha kwesiguli kanye nemiphumela yokuhlolwa enembile.

THOLA ISIKHOPHO MANJE

Incazelo yomkhiqizo weIzinaliti Zokuqoqa Igazi

Iphakethe elilodwa le-EO Sterile.
Indlela yokusebenzisa indlela yokuphepha ngesandla esisodwa. Ukungqongqoza noma ukusunduza ukuze kusebenze indlela yokuphepha. Isembozo sokuphepha sinciphisa izinti zokufaka inaliti ngengozi. Iyahambisana nesibambi se-luer esijwayelekile. Igeyiji 18G-27G.
CE, ISO13485 kanye ne-FDA 510K.

Umthethonqubo:

I-ISO13485

Okujwayelekile:

I-EN ISO 13485: 2016/AC: 2016 Uhlelo lokuphatha ikhwalithi yemishini yezokwelapha lwezidingo zomthetho
I-EN ISO 14971: Amadivayisi ezokwelapha ka-2012 - Ukusetshenziswa kokuphathwa kwezingozi kumadivayisi ezokwelapha
I-ISO 11135:2014 Idivayisi yezokwelapha Ukuhlanza i-ethylene oxide Ukuqinisekiswa nokulawulwa okujwayelekile
I-ISO 6009:2016 Izinaliti zomjovo ezilahlwayo ezingenamagciwane Khomba ikhodi yombala
I-ISO 7864:2016 Izinaliti zomjovo ezilahlwayo ezingenamagciwane
ISO 9626:2016 Amashubhu enaliti yensimbi engagqwali yokwenziwa kwamadivayisi ezokwelapha

Iphrofayela Yenkampani Ye-Teamstand

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