{"id":2332,"date":"2024-11-26T10:16:36","date_gmt":"2024-11-26T02:16:36","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2332"},"modified":"2026-02-09T09:59:05","modified_gmt":"2026-02-09T01:59:05","slug":"terms-and-definitions-of-eto-gas-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/terms-and-definitions-of-eto-gas-sterilization\/","title":{"rendered":"Terms and definitions of eto gas sterilization"},"content":{"rendered":"\n
\"\"<\/figure><\/div>\n\n\n\n

Untuk keperluan dokumen ini, istilah dan definisi berikut berlaku sterilisasi etilen oksida<\/strong><\/p>\n\n\n\n

3.1 Aerasi <\/a><\/strong><\/p>\n\n\n\n

\"\"<\/figure><\/div>\n\n\n\n

part of the eto gas sterilization process during which ethylene oxide and\/or its<\/p>\n\n\n\n

produk reaksi diserap dari perangkat medis hingga tingkat yang telah ditentukan tercapai<\/p>\n\n\n\n

Note 1 to entry: This can be performed within the sterilizer and\/or in a separate chamber or room.<\/p>\n\n\n\n

3.2 area aerasi <\/strong><\/strong><\/p>\n\n\n\n

baik ruangan atau ruangan tempat terjadinya aerasi<\/p>\n\n\n\n

3.3 Beban Hayati <\/strong><\/strong><\/p>\n\n\n\n

population of viable microorganisms on or in product and\/or sterile barrier system<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.2]<\/p>\n\n\n\n

3.4 indikator biologis <\/strong><\/strong><\/p>\n\n\n\n

sistem pengujian yang mengandung mikroorganisme hidup yang memberikan ketahanan tertentu terhadap proses sterilisasi gas eto tertentu<\/p>\n\n\n\n

3.5 Kalibrasi <\/strong><\/strong><\/p>\n\n\n\n

serangkaian operasi yang menetapkan, dalam kondisi tertentu, hubungan antara nilai suatu besaran yang ditunjukkan oleh alat ukur atau pengukuran<\/p>\n\n\n\n

sistem, atau nilai-nilai yang diwakili oleh ukuran material atau bahan referensi, dan nilai-nilai terkait yang diwujudkan oleh standar<\/p>\n\n\n\n

3.6 indikator kimia <\/strong><\/strong><\/p>\n\n\n\n

sistem pengujian yang mengungkapkan perubahan dalam satu atau lebih variabel proses yang telah ditentukan sebelumnya<\/p>\n\n\n\n

berdasarkan perubahan kimia atau fisika yang dihasilkan dari paparan suatu proses<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.6]<\/p>\n\n\n\n

3.7 Pengkondisian <\/a><\/strong><\/p>\n\n\n\n

pengolahan produk dalam siklus sterilisasi gas eto, tetapi sebelum etilen<\/p>\n\n\n\n

penerimaan oksida, untuk mencapai suhu dan kelembaban relatif yang telah ditentukan<\/p>\n\n\n\n

Catatan 1 untuk entri: Bagian dari siklus sterilisasi etilen oksida ini dapat dilakukan pada tekanan atmosfer atau dalam kondisi vakum.<\/p>\n\n\n\n

Catatan 2 untuk entri: Lihat 3.27, pengkondisian awal<\/p>\n\n\n\n

3.8 <\/strong>D <\/em><\/strong><\/em><\/strong>nilai <\/strong><\/strong><\/p>\n\n\n\n

D<\/em>10 nilai <\/strong><\/strong><\/p>\n\n\n\n

waktu atau dosis yang diperlukan untuk mencapai inaktivasi 90% populasi mikroorganisme uji dalam kondisi yang ditentukan<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.11] ?<\/p>\n\n\n\n

Catatan 1 untuk entri: Untuk tujuan Standar Internasional ini, D <\/em>nilai adalah waktu pemaparan yang diperlukan untuk mencapai 90 % inaktivasi populasi organisme uji.<\/p>\n\n\n\n

3.9 Pembangunan <\/strong><\/strong><\/p>\n\n\n\n

tindakan mengelaborasi suatu spesifikasi<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.13]<\/p>\n\n\n\n

3,10 titik embun <\/strong><\/strong><\/p>\n\n\n\n

Suhu di mana tekanan uap air jenuh sama dengan<\/p>\n\n\n\n

tekanan parsial uap air di atmosfer<\/p>\n\n\n\n

Catatan 1 untuk entri: Setiap pendinginan atmosfer di bawah titik embun akan menghasilkan kondensasi air.<\/p>\n\n\n\n

3.11 Menetapkan <\/strong><\/strong><\/p>\n\n\n\n

ditentukan dengan evaluasi teoritis dan dikonfirmasi dengan eksperimen<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.17]<\/p>\n\n\n\n

9ISO 11135-2014<\/p>\n\n\n\n

3.12 waktu injeksi etilen oksida (EO).<\/strong> <\/a><\/p>\n\n\n\n

durasi tahap yang dimulai dengan pemasukan pertama EO (campuran) ke dalam ruangan sampai selesainya injeksi tersebut<\/p>\n\n\n\n

3.13 waktu pemaparan <\/strong><\/strong><\/p>\n\n\n\n

periode dimana parameter proses dipertahankan dalam toleransi yang ditentukan<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.18]<\/p>\n\n\n\n

Catatan 1 untuk entri: Untuk tujuan penghitungan siklus mematikan, ini adalah periode sterilisasi etilen oksida antara akhir injeksi EO dan awal penghilangan EO.<\/p>\n\n\n\n

3.14 Kesalahan <\/strong><\/strong><\/p>\n\n\n\n

one or more of the process parameters lying outside of its\/their specified<\/p>\n\n\n\n

toleransi<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.19]<\/p>\n\n\n\n

3.15 Pembilasan <\/strong><\/strong><\/p>\n\n\n\n

prosedur dimana etilen oksida dikeluarkan dari beban dan ruang<\/p>\n\n\n\n

dengan beberapa pemasukan udara, gas inert atau uap yang disaring secara bergantian dan evakuasi dari ruang atau aliran udara yang disaring, gas atau uap lembam 10ISO 11135-2014 secara terus menerus melalui beban dan ruang<\/p>\n\n\n\n

3.16 siklus pecahan <\/strong><\/strong><\/p>\n\n\n\n

sebuah siklus di mana waktu pemaparan terhadap gas EO berkurang dibandingkan dengan itu<\/p>\n\n\n\n

ditentukan dalam proses sterilisasi etilen oksida<\/p>\n\n\n\n

3.17 setengah siklus <\/strong><\/strong><\/p>\n\n\n\n

siklus di mana waktu pemaparan terhadap gas EO dikurangi sebesar 50 % dibandingkan dengan yang ditentukan dalam proses sterilisasi etilen oksida<\/p>\n\n\n\n

3.18 fasilitas pelayanan kesehatan <\/strong><\/strong><\/p>\n\n\n\n

organisasi dan lembaga pemerintah dan swasta yang mengabdi pada<\/p>\n\n\n\n

promosi dan pemeliharaan kesehatan, serta pencegahan dan pengobatan<\/p>\n\n\n\n

penyakit dan cedera<\/p>\n\n\n\n

CONTOH Fasilitas pelayanan kesehatan dapat berupa rumah sakit, panti jompo, fasilitas perawatan tambahan, pusat bedah mandiri, klinik, kantor kesehatan, atau klinik gigi.<\/p>\n\n\n\n

3.19 produk perawatan kesehatan <\/strong><\/strong><\/p>\n\n\n\n

perangkat medis, termasuk secara in vitro <\/em>alat kesehatan diagnostik, atau produk obat, termasuk biofarmasi<\/p>\n\n\n\n

11 ISO 11135-2014<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.20]<\/p>\n\n\n\n

3.20 kualifikasi instalasi <\/a><\/strong><\/p>\n\n\n\n

proses memperoleh dan mendokumentasikan bukti bahwa peralatan telah disediakan<\/p>\n\n\n\n

dan dipasang sesuai dengan spesifikasinya<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.22]<\/p>\n\n\n\n

3.21 alat kesehatan <\/strong><\/strong><\/p>\n\n\n\n

segala instrumen, peralatan, alat, mesin, alat, implan, secara in vitro <\/em>reagen atau kalibrator, perangkat lunak, bahan atau barang terkait, yang dimaksudkan oleh produsen untuk digunakan, sendiri atau bersama-sama, bagi manusia untuk satu atau lebih tujuan khusus dari<\/p>\n\n\n\n

\u2014 diagnosis, prevention, monitoring, treatment or alleviation of disease,<\/p>\n\n\n\n

\u2014 diagnosis, monitoring, treatment, alleviation of, or compensation for an injury,<\/p>\n\n\n\n

\u2014 investigation, replacement or modification or support of the anatomy or of a physiological process,<\/p>\n\n\n\n

\u2014 control of conception,<\/p>\n\n\n\n

\u2014 disinfection of medical devices,<\/p>\n\n\n\n

\u2014 providing information for medical purposes by means of secara in vitro <\/em>pemeriksaan spesimen yang berasal dari tubuh manusia, dan yang tidak mencapai efek utama yang diharapkan di dalam atau pada tubuh manusia melalui cara farmakologi, imunologi, atau metabolik, namun fungsinya dapat dibantu dengan cara tersebut.<\/p>\n\n\n\n

[SUMBER: ISO 13485:2003, definisi 3.7]<\/p>\n\n\n\n

?<\/p>\n\n\n\n

3.22 mikroorganisme <\/strong><\/strong><\/p>\n\n\n\n

entitas berukuran mikroskopis, meliputi bakteri, jamur, protozoa dan virus<\/p>\n\n\n\n

Catatan 1 untuk entri: Standar tertentu mungkin tidak memerlukan demonstrasi<\/p>\n\n\n\n

efektivitas proses sterilisasi gas eto dalam menonaktifkan semua jenis<\/p>\n\n\n\n

microorganisms, identified in the definition above, for validation and\/or<\/p>\n\n\n\n

pengendalian rutin proses sterilisasi gas eto.<\/p>\n\n\n\n

3.23 kualifikasi operasional <\/a><\/strong><\/p>\n\n\n\n

proses memperoleh dan mendokumentasikan bukti peralatan terpasang<\/p>\n\n\n\n

beroperasi dalam batas yang telah ditentukan apabila digunakan sesuai dengan ketentuannya<\/p>\n\n\n\n

prosedur operasional<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.27]<\/p>\n\n\n\n

3.24 pendekatan berlebihan<\/strong><\/strong><\/p>\n\n\n\n

pendekatan menggunakan proses sterilisasi gas eto yang menghasilkan minimal 12 Spore Log<\/p>\n\n\n\n

Reduksi (SLR) menjadi indikator biologis yang mempunyai ketahanan sama dengan atau lebih besar dari produk bioburden<\/p>\n\n\n\n

3.25 rilis parametrik <\/strong><\/strong><\/p>\n\n\n\n

pernyataan bahwa produk steril, berdasarkan catatan yang menunjukkan bahwa parameter proses dikirimkan dalam toleransi yang ditentukan<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.29]<\/p>\n\n\n\n

Catatan 1 untuk entri: Metode pelepasan proses ini tidak mencakup penggunaan indikator biologis.<\/p>\n\n\n\n

3.26 kualifikasi kinerja <\/a><\/strong><\/p>\n\n\n\n

proses memperoleh dan mendokumentasikan bukti bahwa peralatan, yang dipasang dan dioperasikan sesuai dengan prosedur operasional, secara konsisten bekerja sesuai dengan kriteria yang telah ditentukan dan dengan demikian menghasilkan produk yang memenuhi spesifikasinya<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.30]<\/p>\n\n\n\n

3.27 Pengkondisian awal <\/a><\/strong><\/p>\n\n\n\n

pengolahan produk, sebelum siklus sterilisasi gas eto, di dalam ruangan atau ruang untuk mencapai kondisi suhu dan kelembaban relatif tertentu<\/p>\n\n\n\n

3.28 perangkat tantangan proses <\/strong><\/strong><\/p>\n\n\n\n

item yang dirancang untuk memiliki ketahanan tertentu terhadap proses sterilisasi gas aeto dan digunakan untuk menilai kinerja proses<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.33]<\/p>\n\n\n\n

Catatan 1 untuk entri: Untuk tujuan Standar Internasional ini, PCD dapat<\/p>\n\n\n\n

berupa produk, produk simulasi atau alat lain yang diinokulasi secara langsung atau<\/p>\n\n\n\n

secara tidak langsung. Lihat 7.1.6 dan D.7.1.6.<\/p>\n\n\n\n

Catatan 2 untuk entri: Dalam Standar Internasional ini, perbedaan dibuat antara PCD internal dan PCD eksternal. PCD internal digunakan untuk menunjukkan bahwa SAL produk yang dibutuhkan telah tercapai. PCD yang terletak di dalam batas produk atau kotak pengirim produk adalah PCD internal, sedangkan PCD yang terletak di antara kotak pengirim atau pada permukaan luar muatan adalah PCD eksternal. PCD eksternal adalah item yang dirancang untuk digunakan untuk mikrobiologi<\/p>\n\n\n\n

pemantauan siklus produksi rutin.<\/p>\n\n\n\n

3.29 parameter proses <\/strong><\/strong><\/p>\n\n\n\n

nilai yang ditentukan untuk variabel proses<\/p>\n\n\n\n

Catatan 1 untuk entri: Spesifikasi proses sterilisasi gas eto mencakup<\/p>\n\n\n\n

parameter proses dan toleransinya.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.34]<\/p>\n\n\n\n

3.30 variabel proses <\/strong><\/strong><\/p>\n\n\n\n

kondisi dalam proses sterilisasi etilen oksida, perubahan yang mengubah efektivitas mikrobisida<\/p>\n\n\n\n

CONTOH?Waktu, suhu, tekanan, konsentrasi, kelembaban, panjang gelombang.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.35]<\/p>\n\n\n\n

3.31 kategori pemrosesan <\/strong><\/strong><\/p>\n\n\n\n

kumpulan produk atau kelompok produk berbeda yang dapat disterilkan<\/p>\n\n\n\n

bersama<\/p>\n\n\n\n

Catatan 1 untuk entri: Semua produk dalam kategori tersebut telah ditentukan untuk memberikan tantangan yang sama atau lebih kecil terhadap proses sterilisasi etilen oksida dibandingkan perangkat tantangan proses untuk kelompok tersebut.<\/p>\n\n\n\n

3.32 Produk <\/strong><\/strong><\/p>\n\n\n\n

hasil dari suatu proses<\/p>\n\n\n\n

[SUMBER: ISO 9000:2005, definisi 3.4.2]<\/p>\n\n\n\n

Catatan 1 untuk entri: Untuk keperluan standar sterilisasi etilen oksida, produknya adalah<\/p>\n\n\n\n

berwujud dan dapat berupa bahan mentah, bahan antara, sub-rakitan, dan<\/p>\n\n\n\n

produk perawatan kesehatan.<\/p>\n\n\n\n

3.33 kelompok produk <\/strong><\/strong><\/p>\n\n\n\n

sekelompok produk yang mempunyai karakteristik yang memungkinkan untuk disterilkan<\/p>\n\n\n\n

menggunakan kondisi proses yang ditentukan<\/p>\n\n\n\n

3,34 volume pemuatan produk<\/strong><\/strong><\/p>\n\n\n\n

ruang tertentu dalam volume ruang yang dapat digunakan yang ditempati oleh produk<\/p>\n\n\n\n

3.35 koleksi budaya yang diakui <\/strong><\/strong><\/p>\n\n\n\n

otoritas penyimpanan di bawah Perjanjian Budapest tentang Internasional<\/em><\/p>\n\n\n\n

Pengakuan Deposito<\/em><\/p>\n\n\n\n

Mikroorganisme untuk Tujuan Paten dan Regulasi<\/em><\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.38]<\/p>\n\n\n\n

3.36 mikroorganisme referensi <\/strong><\/p>\n\n\n\n

strain mikroba yang diperoleh dari koleksi budaya yang diakui<\/p>\n\n\n\n

3.37 Rekualifikasi <\/strong><\/p>\n\n\n\n

pengulangan bagian validasi untuk tujuan mengkonfirmasikan kelanjutan penerimaan proses tertentu<\/p>\n\n\n\n

3.38 alat kesehatan yang dapat digunakan kembali <\/strong><\/strong><\/p>\n\n\n\n

alat kesehatan yang ditunjuk atau dimaksudkan oleh produsen sesuai untuk<\/p>\n\n\n\n

pengolahan ulang dan penggunaan kembali<\/p>\n\n\n\n

Catatan 1 untuk entri: Ini bukan perangkat medis yang ditujukan atau dimaksudkan<\/p>\n\n\n\n

oleh pabrikan hanya untuk sekali pakai.<\/p>\n\n\n\n

3.39 Layanan <\/strong><\/strong><\/p>\n\n\n\n

pasokan dari sumber eksternal, yang diperlukan agar peralatan berfungsi dengan benar<\/p>\n\n\n\n

CONTOH Listrik, air, udara bertekanan, drainase.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.41]<\/p>\n\n\n\n

3.40 alat kesehatan sekali pakai <\/strong><\/p>\n\n\n\n

perangkat medis yang ditunjuk atau dimaksudkan oleh produsen untuk penggunaan satu kali saja<\/p>\n\n\n\n

3.41 Tentukan <\/strong><\/strong><\/p>\n\n\n\n

ditetapkan secara rinci dalam dokumen yang disetujui<\/p>\n\n\n\n

3.42 Pengurangan log spora <\/strong>log populasi spora awal, N<\/em>0, dikurangi log populasi akhir, N<\/em>kamu<\/p>\n\n\n\n

[SUMBER: ISO 14161:2009, definisi 3.19]<\/p>\n\n\n\n

Catatan 1 untuk entri: Menjelaskan pengurangan jumlah spora pada a<\/p>\n\n\n\n

indikator biologis atau item yang diinokulasi dihasilkan oleh paparan yang ditentukan<\/p>\n\n\n\n

kondisi.<\/p>\n\n\n\n

Untuk Pencacahan Langsung:<\/p>\n\n\n\n

SLR = catatan N<\/em>0 mencatat? N<\/em>kamu<\/p>\n\n\n\n

Di mana<\/p>\n\n\n\n

N<\/em>0 adalah populasi awal;<\/p>\n\n\n\n

N<\/em>kamu adalah populasi akhir.<\/p>\n\n\n\n

Untuk Pecahan Negatif:<\/p>\n\n\n\n

SLR = catatan N<\/em>0 \u2013 log [ln (Q<\/em>\/N<\/em>)]<\/p>\n\n\n\n

Di mana<\/p>\n\n\n\n

N<\/em>0 adalah populasi awal;<\/p>\n\n\n\n

Q <\/em>adalah jumlah sampel ulangan yang diuji;<\/p>\n\n\n\n

N <\/em>adalah jumlah sampel yang negatif untuk pertumbuhan.<\/p>\n\n\n\n

Jika tidak ada yang selamat, SLR sebenarnya tidak dapat dihitung. SLRnya bisa<\/p>\n\n\n\n

reported as \u201cgreater than\u201d log N<\/em>0 jika satu organisme yang masih hidup digunakan.<\/p>\n\n\n\n

3.43 Steril <\/strong><\/strong><\/p>\n\n\n\n

bebas dari mikroorganisme yang hidup<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.43]<\/p>\n\n\n\n

3.44 sistem penghalang steril<\/strong><\/strong><\/p>\n\n\n\n

paket minimum yang mencegah masuknya mikroorganisme dan memungkinkan aseptik<\/p>\n\n\n\n

presentasi produk pada saat digunakan<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.44]<\/p>\n\n\n\n

3.45 Kemandulan<\/strong><\/p>\n\n\n\n

keadaan bebas dari mikroorganisme yang hidup<\/p>\n\n\n\n

Catatan 1 untuk entri: Dalam praktiknya, tidak ada pernyataan mutlak mengenai tidak adanya mikroorganisme yang dapat dibuktikan.<\/p>\n\n\n\n

Catatan 2 untuk entri: Lihat 3.47, sterilisasi.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.45]<\/p>\n\n\n\n

3,46 tingkat jaminan sterilitas <\/strong><\/strong><\/p>\n\n\n\n

probabilitas satu mikroorganisme yang hidup muncul pada item setelahnya<\/p>\n\n\n\n

sterilisasi<\/p>\n\n\n\n

Catatan 1 untuk entri: Istilah SAL mempunyai nilai kuantitatif, umumnya 10-6 atau 10-3. Ketika menerapkan nilai kuantitatif ini pada jaminan sterilitas, SAL 10-6 memiliki nilai yang lebih rendah namun memberikan jaminan sterilitas yang lebih besar dibandingkan SAL 10-3.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.46]<\/p>\n\n\n\n

3.47 Sterilisasi <\/a><\/strong><\/p>\n\n\n\n

proses tervalidasi yang digunakan untuk membuat produk bebas dari mikroorganisme yang hidup<\/p>\n\n\n\n

Catatan 1 untuk entri: Dalam proses sterilisasi, sifat mikroba<\/p>\n\n\n\n

inaktivasi bersifat eksponensial dan dengan demikian kelangsungan hidup suatu mikroorganisme pada suatu benda dapat dinyatakan dalam bentuk probabilitas. Sementara ini<\/p>\n\n\n\n

probabilitas dapat dikurangi menjadi angka yang sangat rendah, namun tidak akan pernah dapat dikurangi menjadi nol. ISO 11135-2014<\/p>\n\n\n\n

Catatan 2 untuk entri: Lihat 3.46, tingkat jaminan sterilitas.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.47]<\/p>\n\n\n\n

3.48 siklus sterilisasi <\/a><\/strong><\/p>\n\n\n\n

treatment in a sealed chamber, which includes air removal, conditioning (if used), injection of ethylene oxide, inert gas (if used), exposure to ethylene oxide, removal of ethylene oxide and flushing (if used), and air\/inert gas admission<\/p>\n\n\n\n

3,49 beban sterilisasi <\/strong><\/strong><\/p>\n\n\n\n

produk yang akan atau telah disterilkan bersama-sama dengan menggunakan yang diberikan<\/p>\n\n\n\n

proses sterilisasi<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.48]<\/p>\n\n\n\n

3,50 proses sterilisasi <\/a><\/strong><\/p>\n\n\n\n

serangkaian tindakan atau operasi yang diperlukan untuk mencapai persyaratan sterilitas yang ditentukan<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.49]<\/p>\n\n\n\n

Catatan 1 untuk entri: Rangkaian tindakan atau operasi ini mencakup pengkondisian awal<\/p>\n\n\n\n

(jika diperlukan), paparan terhadap etilen oksida dalam kondisi tertentu dan setiap pasca-perawatan yang diperlukan untuk menghilangkan etilen oksida dan produk sampingannya. Ini tidak termasuk operasi pembersihan, desinfeksi, atau pengemasan apa pun yang mendahului proses sterilisasi.<\/p>\n\n\n\n

3.51 spesialis sterilisasi <\/strong><\/strong><\/p>\n\n\n\n

orang yang memiliki pengetahuan teknis tentang teknologi sterilisasi yang digunakan dan pengaruhnya terhadap bahan dan mikroorganisme<\/p>\n\n\n\n

3.52 bahan sterilisasi <\/strong><\/strong><\/p>\n\n\n\n

inasi entitas yang memiliki aktivitas mikrobisida yang cukup untuk mencapai sterilitas dalam kondisi tertentu<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.50]<\/p>\n\n\n\n

3,53 kurva penyintas <\/strong><\/p>\n\n\n\n

representasi grafis dari inaktivasi populasi mikroorganisme dengan meningkatnya paparan agen mikrobisida dalam kondisi tertentu<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.51]<\/p>\n\n\n\n

3.54 uji sterilitas <\/strong><\/strong><\/p>\n\n\n\n

operasi teknis yang ditentukan dalam Farmakope yang dilakukan pada produk setelah terpapar pada proses sterilisasi<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.53]<\/p>\n\n\n\n

3,55 uji sterilitas <\/strong><\/strong><\/p>\n\n\n\n

operasi teknis yang dilakukan sebagai bagian dari pengembangan, validasi, atau<\/p>\n\n\n\n

kualifikasi ulang untuk menentukan ada tidaknya mikroorganisme yang hidup pada produk atau bagiannya<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.54]<\/p>\n\n\n\n

3,56 volume ruang yang dapat digunakan <\/strong><\/strong><\/p>\n\n\n\n

ruang tertentu di dalam ruang sterilisasi, yang tidak dibatasi oleh komponen tetap atau bergerak dan tersedia untuk menerima beban sterilisasi<\/p>\n\n\n\n

Catatan 1 untuk entri: Volume yang diperbolehkan untuk sirkulasi gas di sekitar muatan di dalamnya<\/p>\n\n\n\n

ruangan tersebut tidak termasuk sebagai ruang yang dapat digunakan.<\/p>\n\n\n\n

3.57 Validasi <\/a><\/strong><\/p>\n\n\n\n

prosedur terdokumentasi untuk memperoleh, mencatat dan menafsirkan hasil yang diperlukan untuk menetapkan bahwa suatu proses akan secara konsisten menghasilkan produk yang memenuhi spesifikasi yang telah ditentukan<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.55]<\/p>\n\n\n\n

3,58 bahan perawan <\/strong><\/p>\n\n\n\n

bahan yang belum pernah digunakan sebelumnya, atau mengalami pemrosesan selain untuk produksi aslinya<\/p>\n\n\n\n

JIKA ANDA INGIN TAHU LEBIH LANJUT Tentang Sterilisasi Etilen Oksida<\/h2>\n\n\n\n

Telepon:+8619975258603<\/a><\/p>\n\n\n\n

E-mail:hayley@hzbocon.com<\/a><\/p>\n\n\n\n

Situs Lokal: Kamar 1202, Caitong Zhongxin, Distrik Xiasha, Kota Hangzhou, Provinsi Zhejiang, Tiongkok<\/p>\n\n\n\n

Situs web:hzbocon.com<\/a> zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Untuk keperluan dokumen ini, istilah dan definisi berikut berlaku dalam sterilisasi etilen oksida 3.1 Aerasi bagian dari […]<\/p>\n","protected":false},"author":234312599,"featured_media":8477,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center 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