Amahugurwa yubushyuhe bwibiryo

1. Intego zamahugurwa

Binyuze mu mahugurwa, kunoza uburyo bwo kuboneza urubyaro hamwe n’urwego rufatika rw’abahugurwa, gukemura ibibazo bitoroshye byagaragaye mu gihe cyo gukoresha ibikoresho no gufata neza ibikoresho, guteza imbere ibikorwa bisanzwe, no guteza imbere ubumenyi n’umutekano by’ibiryo byangiza.

Aya mahugurwa yihatira gufasha abahugurwa kumenya byimazeyo ubumenyi bwibanze bwibanze bwibiryo byangiza ibiryo, kumenya amahame, uburyo nintambwe zo gushyiraho uburyo bwo kuboneza urubyaro, kandi bamenyereye kandi batezimbere imikorere myiza mubikorwa byo guhagarika ibiryo byumuriro, no kunoza ibishoboka yo guhura mubikorwa byo kurya ibiryo bya sterisizasiyo.Ubushobozi bwo gukemura ibibazo byagezweho.

2. Ibikubiye mu mahugurwa

(1) Ihame ryibanze ryo guhagarika ubushyuhe bwibiryo byafunzwe
1. Amahame yo kubungabunga ibiryo
2. Microbiologiya y'ibiryo byafunzwe
3. Amahame yibanze ya sterilisation yumuriro (D agaciro, Z agaciro, F agaciro, F umutekano, LR nibindi bitekerezo nibikorwa bifatika)
4. Ibisobanuro byintambwe nuburyo bwo gushyiraho amabwiriza yo guhagarika ibiryo

(2) Ibipimo nogukoresha muburyo bwiza bwo kurya ibiryo byumuriro
1. Ibisabwa muri Amerika FDA kubikoresho byo gutwika amashyuza no kuboneza
2. Uburyo busanzwe bwo kuboneza urubyaro busobanurwa intambwe ku ntambwe yo kunanirwa, ubushyuhe burigihe, gukonjesha, uburyo bwo kwinjiza amazi, kugenzura umuvuduko, nibindi.
3. Ibibazo bisanzwe no gutandukana mubikorwa byo guhagarika amashyuza
4. Guhindura inyandiko
5. Ibibazo bikunze kugaragara muburyo bwo gutangiza uburyo bwo kuboneza urubyaro

(3) Gukwirakwiza ubushyuhe bwa retort, ihame ryibizamini byo kwinjiza ubushyuhe no gusuzuma ibisubizo
1. Intego yo gupima thermodynamic
2. Uburyo bwo gupima thermodynamic
3. Ibisobanuro birambuye kumpamvu zigira ingaruka kubisubizo byo gukwirakwiza ubushyuhe bwa sterilizer
4. Gukoresha ikizamini cyo kwinjiza amashyuza mugutegura uburyo bwo guhagarika ibicuruzwa

(4) Ingingo z'ingenzi zo kugenzura mbere yo kuvura
1. Ubushyuhe (ubushyuhe bwibicuruzwa hagati, ubushyuhe bwo gupakira, ubushyuhe bwo kubika, ubushyuhe bwibicuruzwa mbere yo kuboneza)
2. Igihe (igihe cyo kugurisha igihe kibisi kandi gitetse, igihe cyo gukonjesha, igihe cyo kubika mbere yo kuboneza urubyaro)
3. Kugenzura mikorobe (ibikoresho fatizo, gukura, kwanduza ibikoresho nibikoresho byinjira, hamwe na bagiteri mbere yo kuboneza urubyaro)

(5) Kubungabunga no gufata neza ibikoresho byo kuboneza urubyaro

(6) Gukemura ibibazo bisanzwe no gukumira ibikoresho byo kuboneza urubyaro

3. Igihe cyo guhugura
Ku ya 13 Gicurasi 2020


Igihe cyo kohereza: Kanama-08-2020