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Eur. čl. 2.6.12, čl. 2.6.13; ČSN EN ISO 14698-1; ČSN EN ISO 14698-2; ČSN EN 17141","search_text":"Pomieszczenia czyste Oznaczanie zanieczyszczenia mikrobiologicznego (monitoring) metoda hodowlana aeroskop (próbnik powietrza)  sedymentacja (płytki osadowe)  wymazy  odciski powierzchni  odciski palców  Čisté prostory Stanovení mikrobiologické kontaminace (monitoring) kultivačně aeroskop  spady  stěry  otisky povrchů  otisky prstů  SOP-K.8.01, kap. 4.1.1.1; SOP-K.8.01, kap. 4.1.2.1; SOP-K.8.01, kap. 4.2.1; SOP-K.8.01, kap. 4.3.1.1; SOP-K.8.01, kap. 4.3.2.1 Pomieszczenia czyste Oznaczanie zanieczyszczenia mikrobiologicznego (monitoring) metoda hodowlana aeroskop (probnik powietrza)  sedymentacja (plytki osadowe)  wymazy  odciski powierzchni  odciski palcow  Ciste prostory Stanoveni mikrobiologicke kontaminace (monitoring) kultivacne aeroskop  spady  stery  otisky povrchu  otisky prstu  SOP-K.8.01, kap. 4.1.1.1; SOP-K.8.01, kap. 4.1.2.1; SOP-K.8.01, kap. 4.2.1; SOP-K.8.01, kap. 4.3.1.1; SOP-K.8.01, kap. 4.3.2.1","search_en":"Cleanrooms Determination of microbiological contamination (monitoring) by culture aeroscope  fall-outs  swabs  surface prints  finger prints  SOP-K.8.01, kap. 4.1.1.1; 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SOP-K.8.01, kap. 4.1.2 Pomieszczenia czyste Pobieranie probek powietrza aeroskop (probnik powietrza)  sedymentacja (plytki osadowe)  Ciste prostory Odbery vzorku vzduchu aeroskop  spady  SOP-K.8.01, kap. 4.1.1; SOP-K.8.01, kap. 4.1.2","search_en":"Cleanrooms Sampling of air aeroscope  fall-outs  SOP-K.8.01, kap. 4.1.1; SOP-K.8.01, kap. 4.1.2","search_zh":"洁净室 空气采样 空气采样器  沉降菌  SOP-K.8.01, kap. 4.1.1; SOP-K.8.01, kap. 4.1.2","categories":["microbiology","pharma"],"categories_source":"reczne","source_lang":"cs","translation":{"pl":"reczna-analiza-labcoda-3","en":"CIA-oficjalne","zh":"reczna-analiza-labcoda-3"},"row_index":4,"parse_version":5,"parse_source":"reczna-analiza-labcoda-3"},{"_id":"8956987e16320cfaef20851f","lab_id":"69ad52a4de79e566650fd526","country":"CZ","accr_number":"1678","accr_body":"ČIA","row_label":"2","test_object":"Pomieszczenia czyste","test_object_en":"Cleanrooms","test_object_zh":"洁净室","test_object_cs":"Čisté prostory","methodology":"Pobieranie próbek z powierzchni","methodology_en":"Sampling of surfaces","methodology_zh":"表面采样","methodology_cs":"Odběry vzorků z povrchů","parameters":[{"name":"wymazy","range":""},{"name":"odciski powierzchni","range":""},{"name":"odciski palców","range":""},{"name":"odciski odzieży","range":""}],"parameters_en":[{"name":"swabs","range":""},{"name":"surface prints","range":""},{"name":"finger prints","range":""},{"name":"clothing prints","range":""}],"parameters_zh":[{"name":"擦拭","range":""},{"name":"表面接触碟","range":""},{"name":"指印","range":""},{"name":"衣物接触碟","range":""}],"parameters_cs":[{"name":"stěry","range":""},{"name":"otisky povrchů","range":""},{"name":"otisky prstů","range":""},{"name":"otisky oděvů","range":""}],"technique":null,"technique_en":null,"technique_zh":null,"technique_cs":null,"techniques":[],"techniques_en":[],"techniques_zh":[],"techniques_cs":[],"computed":[],"computed_en":[],"computed_zh":[],"computed_cs":[],"activity":"Pobieranie próbek z powierzchni\nZakres:\nwymazy\nodciski powierzchni\nodciski palców\nodciski odzieży","reference":"SOP-K.8.01, kap. 4.2; 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SOP-K.8.01, kap. 4.3.1; SOP-K.8.01, kap. 4.3.2; SOP-K.8.01, kap. 4.3.3 Pomieszczenia czyste Pobieranie probek z powierzchni wymazy  odciski powierzchni  odciski palcow  odciski odziezy  Ciste prostory Odbery vzorku z povrchu stery  otisky povrchu  otisky prstu  otisky odevu  SOP-K.8.01, kap. 4.2; SOP-K.8.01, kap. 4.3.1; SOP-K.8.01, kap. 4.3.2; SOP-K.8.01, kap. 4.3.3","search_en":"Cleanrooms Sampling of surfaces swabs  surface prints  finger prints  clothing prints  SOP-K.8.01, kap. 4.2; SOP-K.8.01, kap. 4.3.1; SOP-K.8.01, kap. 4.3.2; SOP-K.8.01, kap. 4.3.3","search_zh":"洁净室 表面采样 擦拭  表面接触碟  指印  衣物接触碟  SOP-K.8.01, kap. 4.2; SOP-K.8.01, kap. 4.3.1; SOP-K.8.01, kap. 4.3.2; SOP-K.8.01, kap. 4.3.3","categories":["microbiology","pharma"],"categories_source":"reczne","source_lang":"cs","translation":{"pl":"reczna-analiza-labcoda-3","en":"CIA-oficjalne","zh":"reczna-analiza-labcoda-3"},"row_index":5,"parse_version":5,"parse_source":"reczna-analiza-labcoda-3"},{"_id":"dc4839aa82242e6769ffa395","lab_id":"69ad52a4de79e566650fd526","country":"CZ","accr_number":"1678","accr_body":"ČIA","row_label":"1","test_object":"Wyroby medyczne","test_object_en":"Medical devices","test_object_zh":"医疗器械","test_object_cs":"Zdravotnické prostředky","methodology":"Badanie jałowości","methodology_en":"Sterility test","methodology_zh":"无菌检查","methodology_cs":"Zkouška na sterilitu","parameters":[],"parameters_en":[],"parameters_zh":[],"parameters_cs":[],"technique":"metoda hodowlana","technique_en":"by culture","technique_zh":"培养法","technique_cs":"kultivačně","techniques":["metoda hodowlana"],"techniques_en":["by culture"],"techniques_zh":["培养法"],"techniques_cs":["kultivačně"],"computed":[],"computed_en":[],"computed_zh":[],"computed_cs":[],"activity":"Badanie jałowości\nmetoda hodowlana","reference":"SOP-K.1.01 (Ph. 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Zdravotnické prostředky Odhad populace mikroorganismů (bioburden) (Žluč tolerující G- bakterie, Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella sp.) kultivačně Žluč tolerující G- bakterie  Staphylococcus aureus  Pseudomonas aeruginosa  Salmonella sp.  SOP-K.4.11 (ČSN EN ISO 11737-1; Ph. Eur. čl. 2.6.12, čl. 2.6.13; USP <61>; USP <62>) Wyroby medyczne Szacowanie populacji mikroorganizmow (bioburden) (bakterie Gram-ujemne tolerujace zolc, Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella sp.) metoda hodowlana Bakterie Gram-ujemne tolerujace zolc  Staphylococcus aureus  Pseudomonas aeruginosa  Salmonella sp.  Zdravotnicke prostredky Odhad populace mikroorganismu (bioburden) (Zluc tolerujici G- bakterie, Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella sp.) kultivacne Zluc tolerujici G- bakterie  Staphylococcus aureus  Pseudomonas aeruginosa  Salmonella sp.  SOP-K.4.11 (CSN EN ISO 11737-1; Ph. Eur. cl. 2.6.12, cl. 2.6.13; USP <61>; USP <62>)","search_en":"Medical devices Determination of a population of microorganisms (bioburden) (Bile tolerant G- bacteria, Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella sp.) by culture Bile tolerant G- bacteria  Staphylococcus aureus  Pseudomonas aeruginosa  Salmonella sp.  SOP-K.4.11 (ČSN EN ISO 11737-1; Ph. Eur. čl. 2.6.12, čl. 2.6.13; USP <61>; USP <62>)","search_zh":"医疗器械 微生物总数（生物负载）估算（耐胆盐革兰氏阴性菌、金黄色葡萄球菌、铜绿假单胞菌、沙门氏菌） 培养法 耐胆盐革兰氏阴性菌  金黄色葡萄球菌（Staphylococcus aureus）  铜绿假单胞菌（Pseudomonas aeruginosa）  沙门氏菌（Salmonella sp.）  SOP-K.4.11 (ČSN EN ISO 11737-1; Ph. Eur. čl. 2.6.12, čl. 2.6.13; USP <61>; USP <62>)","categories":["microbiology","pharma"],"categories_source":"reczne","source_lang":"cs","translation":{"pl":"reczna-analiza-labcoda-3","en":"CIA-oficjalne","zh":"reczna-analiza-labcoda-3"},"row_index":7,"parse_version":5,"parse_source":"reczna-analiza-labcoda-3"},{"_id":"b1f612c7570eee79f1f2e0a6","lab_id":"69ad52a4de79e566650fd526","country":"CZ","accr_number":"1678","accr_body":"ČIA","row_label":"3","test_object":"Pomieszczenia czyste","test_object_en":"Cleanrooms","test_object_zh":"洁净室","test_object_cs":"Čisté prostory","methodology":"Oznaczanie zanieczyszczenia mikrobiologicznego (monitoring)","methodology_en":"Determination of microbiological contamination (monitoring)","methodology_zh":"微生物污染的测定（监测）","methodology_cs":"Stanovení mikrobiologické kontaminace (monitoring)","parameters":[{"name":"aeroskop (próbnik powietrza)","range":""},{"name":"sedymentacja (płytki osadowe)","range":""},{"name":"wymazy","range":""},{"name":"odciski powierzchni","range":""},{"name":"odciski palców","range":""}],"parameters_en":[{"name":"aeroscope","range":""},{"name":"fall-outs","range":""},{"name":"swabs","range":""},{"name":"surface prints","range":""},{"name":"finger prints","range":""}],"parameters_zh":[{"name":"空气采样器","range":""},{"name":"沉降菌","range":""},{"name":"擦拭","range":""},{"name":"表面接触碟","range":""},{"name":"指印","range":""}],"parameters_cs":[{"name":"aeroskop","range":""},{"name":"spady","range":""},{"name":"stěry","range":""},{"name":"otisky povrchů","range":""},{"name":"otisky prstů","range":""}],"technique":"metoda hodowlana","technique_en":"by culture","technique_zh":"培养法","technique_cs":"kultivačně","techniques":["metoda hodowlana"],"techniques_en":["by culture"],"techniques_zh":["培养法"],"techniques_cs":["kultivačně"],"computed":[],"computed_en":[],"computed_zh":[],"computed_cs":[],"activity":"Oznaczanie zanieczyszczenia mikrobiologicznego (monitoring)\nZakres:\naeroskop (próbnik powietrza)\nsedymentacja (płytki osadowe)\nwymazy\nodciski powierzchni\nodciski palców\nmetoda hodowlana","reference":"SOP-K.8.01, kap. 4.1.1.1; SOP-K.8.01, kap. 4.1.2.1; SOP-K.8.01, kap. 4.2.1; SOP-K.8.01, kap. 4.3.1.1; SOP-K.8.01, kap. 4.3.2.1","norm_bases":["SOP-K.8.01, kap. 4.1.1.1","SOP-K.8.01, kap. 4.1.2.1","SOP-K.8.01, kap. 4.2.1","SOP-K.8.01, kap. 4.3.1.1","SOP-K.8.01, kap. 4.3.2.1"],"lab_section":"Laboratorium Kontrolne BV","lab_section_en":"BV Inspection Laboratory","lab_section_zh":"BV检验实验室","lab_section_cs":"Kontrolní laboratoř BV","lab_address":"Bílé Vchýnice 10, 533 16 Vápno u Přelouče","regulatory_area":"Badania","regulatory_area_en":"Tests","regulatory_area_zh":"检测","regulatory_area_cs":"Zkoušky","flexible":false,"flexibility":null,"outside_premises":false,"note":"literatura źródłowa: Ph. Eur. čl. 2.6.12, čl. 2.6.13; ČSN EN ISO 14698-1; ČSN EN ISO 14698-2; ČSN EN 17141","note_en":"source literature: Ph. Eur. cl. 2.6.12, cl. 2.6.13; ČSN EN ISO 14698-1; ČSN EN ISO 14698-2; ČSN EN 17141","note_zh":"来源文献：Ph. Eur. čl. 2.6.12, čl. 2.6.13; ČSN EN ISO 14698-1; ČSN EN ISO 14698-2; ČSN EN 17141","note_cs":"Ph. Eur. čl. 2.6.12, čl. 2.6.13; ČSN EN ISO 14698-1; ČSN EN ISO 14698-2; ČSN EN 17141","search_text":"Pomieszczenia czyste Oznaczanie zanieczyszczenia mikrobiologicznego (monitoring) metoda hodowlana aeroskop (próbnik powietrza)  sedymentacja (płytki osadowe)  wymazy  odciski powierzchni  odciski palców  Čisté prostory Stanovení mikrobiologické kontaminace (monitoring) kultivačně aeroskop  spady  stěry  otisky povrchů  otisky prstů  SOP-K.8.01, kap. 4.1.1.1; SOP-K.8.01, kap. 4.1.2.1; SOP-K.8.01, kap. 4.2.1; SOP-K.8.01, kap. 4.3.1.1; SOP-K.8.01, kap. 4.3.2.1 Pomieszczenia czyste Oznaczanie zanieczyszczenia mikrobiologicznego (monitoring) metoda hodowlana aeroskop (probnik powietrza)  sedymentacja (plytki osadowe)  wymazy  odciski powierzchni  odciski palcow  Ciste prostory Stanoveni mikrobiologicke kontaminace (monitoring) kultivacne aeroskop  spady  stery  otisky povrchu  otisky prstu  SOP-K.8.01, kap. 4.1.1.1; SOP-K.8.01, kap. 4.1.2.1; SOP-K.8.01, kap. 4.2.1; SOP-K.8.01, kap. 4.3.1.1; SOP-K.8.01, kap. 4.3.2.1","search_en":"Cleanrooms Determination of microbiological contamination (monitoring) by culture aeroscope  fall-outs  swabs  surface prints  finger prints  SOP-K.8.01, kap. 4.1.1.1; SOP-K.8.01, kap. 4.1.2.1; SOP-K.8.01, kap. 4.2.1; SOP-K.8.01, kap. 4.3.1.1; SOP-K.8.01, kap. 4.3.2.1","search_zh":"洁净室 微生物污染的测定（监测） 培养法 空气采样器  沉降菌  擦拭  表面接触碟  指印  SOP-K.8.01, kap. 4.1.1.1; SOP-K.8.01, kap. 4.1.2.1; SOP-K.8.01, kap. 4.2.1; SOP-K.8.01, kap. 4.3.1.1; SOP-K.8.01, kap. 4.3.2.1","categories":["microbiology","pharma"],"categories_source":"reczne","source_lang":"cs","translation":{"pl":"reczna-analiza-labcoda-3","en":"CIA-oficjalne","zh":"reczna-analiza-labcoda-3"},"row_index":8,"parse_version":5,"parse_source":"reczna-analiza-labcoda-3"}],"has_pdf":true}