Tšireletso e nepahetseng ea li-ventilator lisebelisoa tsa bongaka e phetha karolo ea bohlokoa ho netefatsa polokeho ea mokuli le ho thibela ho ata ha tšoaetso.
Linaha tse fapaneng le liindasteri tsa tlhokomelo ea bophelo bo botle li thehile litlhokahalo le melaoana e ikhethileng mabapi le ho bolaea likokoana-hloko tsa li-ventilator tsa ho hema.Sengoliloeng sena se ikemiselitse ho hlahloba litataiso le litekanyetso tse behiloeng ke lichaba tse fapaneng, tse shebaneng le China le linaha tse ling tse tsoetseng pele.Ka ho utloisisa melaoana ena, litsebi tsa tlhokomelo ea bophelo bo botle li ka netefatsa ts'oaetso e sebetsang ea li-ventilator tsa phefumoloho le ho boloka maemo a holimo a tlhokomelo ea bakuli.
1. Litlhoko tsa ho thibela likokoana-hloko Chaena
Chaena, litlhoko tsa ho thibela likokoana-hloko bakeng sa li-ventilator tsa phefumoloho li laoloa ke Khomishene ea Naha ea Bophelo bo Botle (NHC) le Tsamaiso ea Naha ea Taolo ea Mmaraka (SAMR)."Litaelo tsa ho bolaea likokoana-hloko ho Litlhophiso tsa Bophelo bo Botle" tse fanoeng ke NHC li fana ka litaelo tse qaqileng bakeng sa lisebelisoa tsa bongaka tse bolaeang likokoana-hloko, ho kenyelletsa le li-ventilator tsa ho hema.Ho ea ka litataiso tsena, mokhoa oa ho bolaea likokoana-hloko o lokela ho latela melao-motheo ea ho nepahala, ho sebetsa hantle le polokeho.Litataiso li boetse li hlakisa li-disinfectants tse khothalelitsoeng, nako ea ho pepeseha, le moea o nepahetseng nakong ea ts'ebetso ea ho bolaea likokoana-hloko.
Ho feta moo, SAMR e hlokomela ts'ebetsong ea litekanyetso tse kang "Lisebelisoa tsa Bongaka - Litsamaiso tsa Tsamaiso ea Boleng - Litlhoko bakeng sa Maikemisetso a Taolo" (YY/T 0287) le "Medical Devices - Kopo ea Taolo ea Kotsi ho Lisebelisoa tsa Bongaka" (YY/T 0466.1 ).Litekanyetso tsena li netefatsa hore li-ventilator tsa ho hema li fihlela litlhoko tsa boleng 'me li na le likokoana-hloko pele li sebelisoa.
2. Litlhokahalo United States
United States, Tsamaiso ea Lijo le Lithethefatsi (FDA) e fana ka tataiso le melaoana ea ho thibela likokoana-hloko ho li-ventilator tsa ho hema.Ho latela "Tataiso bakeng sa Basebetsi le Basebeletsi ba FDA" ba FDA - Ho sebetsa Lisebelisoa tsa Bongaka ho Litlhophiso tsa Tlhokomelo ea Bophelo bo Botle: Mekhoa ea ho netefatsa le ho ngola, "li-ventilator tsa phefumoloho li lokela ho kena tšebetsong e netefalitsoeng ea ho sebetsa hape ho netefatsa polokeho le katleho ea tsona.
Ho phaella moo, Mokhatlo oa Tsoelo-pele ea Lisebelisoa tsa Bongaka (AAMI) o hatisa litekanyetso tse kang "ANSI / AAMI ST79: 2017 - Tataiso e Feletseng ea Steam Sterilization le Sterility Assurance in Health Care Facilities."Tekanyetso ena e hlalosa mekhoa e metle ea ho bolaea likokoana-hloko le ho thibela likokoana-hloko tsa lisebelisoa tsa bongaka, ho kenyeletsoa le li-ventilator tsa ho hema, ho thibela tšoaetso e amanang le bophelo bo botle.
3. Litlhoko tsa Europe
Europe, litlhoko tsa ho thibela likokoana-hloko bakeng sa li-ventilator tsa phefumoloho li laoloa ke Komiti ea Europe bakeng sa Boemo (CEN) le European Medicines Agency (EMA).CEN e thehile maemo a "EN ISO 17664: 2017 - Sterilization of Medical Devices - Tlhahisoleseding e tla fanoa ke Moetsi bakeng sa Ts'ebetso ea Lisebelisoa tsa Bongaka tse Resterilizable" ho tataisa baetsi ba ho fana ka litaelo tsa ho thibela likokoana-hloko ho lisebelisoa tsa bongaka.
Ho feta moo, EMA e fana ka litataiso le melaoana ea ho thibela likokoana-hloko lisebelisoa tsa bongaka, ho kenyeletsoa le li-ventilator tsa ho hema."Tataiso mabapi le Boleng, Tšireletseho le Katleho ea Lisebelisoa tsa Bongaka" e fanoeng ke EMA e hatisa bohlokoa ba mekhoa e nepahetseng ea ho thibela likokoana-hloko ho netefatsa tšireletso ea mokuli le katleho ea lisebelisoa.
Litlhoko le melaoana ea ho thibela likokoana-hloko bakeng sa li-ventilator tsa ho hema lia fapana ho pholletsa le linaha tse fapaneng, ho bonts'a boitlamo ba machaba ba polokeho ea bakuli le taolo ea tšoaetso.China, Khomishene ea Naha ea Bophelo bo Botle le Tsamaiso ea Naha bakeng sa Taolo ea Mmaraka li fana ka litataiso le litekanyetso tsa ho bolaea likokoana-hloko lisebelisoa tsa bongaka, ho kenyeletsoa le li-ventilator tsa ho hema.United States, Tsamaiso ea Lijo le Lithethefatsi le Mokhatlo oa Tsoelo-pele ea Lisebelisoa tsa Bongaka li phetha karolo ea bohlokoa ho theha tataiso le litekanyetso.Europe, Komiti ea European Standardization le European Medicines Agency e netefatsa polokeho le katleho ea lisebelisoa tsa bongaka ka melao ea bona.
Ka ho latela litlhokahalo le melaoana ena, litsebi tsa tlhokomelo ea bophelo bo botle li ka boloka tikoloho e bolokehileng le e senang kotsi, tsa fokotsa kotsi ea tšoaetso e amanang le bophelo bo botle, le ho netefatsa ts'ebetso e nepahetseng ea li-ventilator tsa ho hema.Ho bohlokoa hore litsi tsa tlhokomelo ea bophelo li lule li nchafalitsoe ka litataiso le litekanyetso tsa morao-rao ho fana ka tlhokomelo e molemohali ho bakuli.
Hopola, mekhoa e nepahetseng ea ho bolaea likokoana-hloko ha e sireletse bakuli feela empa hape e kenya letsoho katlehong e akaretsang ea lits'ebeletso tsa bophelo bo botle lefatšeng ka bophara.
