ISO 13485 Cov cuab yeej siv kho mob zoo tswj qhov system ntawv pov thawj

Cov khoom lag luam muaj feem cuam tshuam rau ISO13485 ntawv pov thawj:

Cov khoom lag luam muaj feem cuam tshuam los ntawm ISO13485 daim ntawv pov thawj tau muab faib ua 7 kev ua haujlwm

1. Cov khoom siv kho mob tsis ua haujlwm
2. Cov khoom siv kho mob ua haujlwm (tsis yog cog tau).
3. Active (implantable) cov cuab yeej kho mob
4. Cov khoom siv kho mob hauv vitro diagnostic
5. Txoj kev ua kom tsis muaj menyuam ntawm cov khoom siv kho mob
6. Cov khoom siv kho mob uas muaj / siv cov tshuaj tshwj xeeb / thev naus laus zis
7. Cov kev pab cuam txog kev kho mob

Cov xwm txheej rau kev thov rau ISO13485 ntawv pov thawj:

Cov neeg thov yuav tsum muaj kev cai lij choj meej

Cov neeg thov yuav tsum muaj cov ntawv tso cai sib xws

1. Rau cov tuam txhab tsim khoom, cov khoom siv hauv chav kawm I yuav tsum tau muab cov khoom siv kho mob cov ntawv pov thawj thiab cov ntawv pov thawj kev tsim khoom; Cov khoom siv hauv chav kawm II thiab III yuav tsum muab daim ntawv pov thawj ntawm cov khoom siv kho mob thiab cov ntawv tso cai tsim khoom siv kho mob;

2. Rau cov lag luam khiav lag luam, cov khoom lag luam hauv Chav II yuav tsum tau muab cov cuab yeej siv kho mob ua haujlwm daim ntawv pov thawj rau npe lag luam; cov khoom lag luam hauv Chav Kawm III yuav tsum tau muab daim ntawv tso cai kho mob ua haujlwm ua lag luam;

3. Rau cov lag luam uas tsuas yog xa tawm, raws li cov ntaub ntawv tshaj tawm los ntawm Ministry of Commerce, Customs thiab Food and Drug Administration thaum Lub Peb Hlis 31, kev xa tawm cov khoom kho mob thiab kev tiv thaiv kab mob sib kis yuav tsum tau txais cov khoom siv kho mob hauv tsev cov khoom lag luam sau npe / ntawv pov thawj ntawm cov khoom siv kho mob. premise ntawm ua tau raws li qhov yuav tsum tau ntawm lub teb chaws importing. Thiab cov cuab yeej kho mob tsim khoom lag luam daim ntawv tso cai / ntawv pov thawj;

Tus neeg thov kev pabcuam tau tsim kom muaj kev tswj xyuas cov ntaub ntawv raws li cov qauv (xws li phau ntawv zoo, cov ntaub ntawv txheej txheem, cov ntaub ntawv tshawb xyuas sab hauv, cov ntaub ntawv tshuaj xyuas kev tswj xyuas thiab lwm yam ntaub ntawv uas xav tau los ntawm cov ntaub ntawv txheej txheem)

Ua ntej thov daim ntawv pov thawj, hauv paus ntsiab lus, cov neeg soj ntsuam kev tswj hwm tau ua haujlwm tau zoo tsawg kawg yog peb lub hlis thiab tau ua tiav kev tshuaj xyuas sab hauv thiab kev tswj xyuas (rau kev tsim cov khoom siv kho mob cog qoob loo, lub kaw lus tau ua haujlwm tsawg kawg 6. lub hlis, thiab rau lwm yam khoom Cov kev tswj hwm tau ua haujlwm tsawg kawg 3 lub hlis)

Qhov tseem ceeb ntawm ISO13485 ntawv pov thawj:

1. Xav txog lub koom haum txoj kev cog lus kom ua tiav cov cai thiab cov cai uas cuam tshuam
2. Pab cov koom haum txhim kho lawv qib kev tswj hwm thiab kev ua haujlwm ntawm kev ua haujlwm, thiab qhia kev ntseeg siab rau pej xeem thiab cov koom haum tswj hwm
3. Tus qauv hais txog qhov yuav tsum tau muaj ntawm kev tswj hwm kev pheej hmoo los pab cov koom haum txo cov kev pheej hmoo ntawm kev raug xwm txheej zoo lossis cov xwm txheej tsis zoo los ntawm kev tswj hwm kev pheej hmoo.