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㻠㻥 㻞 㻞㻚 ᇶᮏせ௳ᇶ‽䜈䛾㐺ᛶ ῧ㈨ᩱ䝝㻙㻝 㻞㻚㻝 ཧ↷つ᱁ぴ ᇶᮏせ௳䜈䛾㐺ᛶ䜢♧䛩䛯䜑䛻⏝䛔䛯つ᱁䛿䚸ୗグ䛾䛸䛚䜚䛷䛒䜛䚹 㡯┠ つ᱁ 〇㐀⟶⌮䞉ရ㉁⟶⌮ 㻙་⒪ᶵჾཬ䜃యእデ⏝་⸆ရ䛾〇㐀⟶⌮ཬ䜃ရ㉁⟶⌮䛾ᇶ‽䛻㛵䛩䜛 ┬௧㻔 ᖹᡂ 㻝㻢 ᖺཌ⏕ປാ┬௧➨ 㻝㻢㻥 㻕 㻙㻱㻺 㻵㻿㻻 㻝㻟㻠㻤㻡䠖㻞㻜㻝㻞 㻹㼑㼐㼕㼏㼍㼘 㼐㼑㼢㼕㼏㼑㼟 䇵 㻽㼡㼍㼘㼕㼠㼥 㼙㼍㼚㼍㼓㼑㼙㼑㼚㼠 㼟㼥㼟㼠㼑㼙㼟㻙㻾㼑㼝㼡㼕㼞㼑㼙㼑㼚㼠㼟 㼒㼛㼞 㼞㼑㼓㼡㼘㼍㼠㼛㼞㼥 㼜㼡㼞㼜㼛㼟㼑㼟 ရ㉁䝅䝇䝔䝮 ་⒪⏝ල䠉 㻵㻿㻻 㻥㻜㻜㻝 䜢㐺⏝䛩䜛䛯䜑䛾≉せồ㡯 䝸䝇䜽䝬䝛䝆䝯䞁䝖 㻙㻱㻺 㻵㻿㻻 㻝㻠㻥㻣㻝䠖㻞㻜㻝㻞 㻹㼑㼐㼕㼏㼍㼘 㼐㼑㼢㼕㼏㼑㼟 㻙 㻭㼜㼜㼘㼕㼏㼍㼠㼕㼛㼚 㼛㼒 㼞㼕㼟㼗 㼙㼍㼚㼍㼓㼑㼙㼑㼚㼠 㼠㼛 㼙㼑㼐㼕㼏㼍㼘 㼐㼑㼢㼕㼏㼑㼟 ་⒪ᶵჾ䠉་⒪ᶵჾ䜈䛾䝸䝇䜽䝬䝛䝆䝯䞁䝖䛾㐺⏝ ᮏᶵჾ≉᭷䛾つ᱁ 㻙㻵㻿㻻 㻝㻠㻢㻟㻜㻦㻞㻜㻝㻞㻘 㻮㻿 㻱㻺 㻵㻿㻻 㻝㻠㻢㻟㻜㻦㻞㻜㻝㻞 㻙 㻺㼛㼚㻙㼍㼏㼠㼕㼢㼑 㼟㼡㼞㼓㼕㼏㼍㼘 㼕㼙㼜㼘㼍㼚㼠㼟䇶㻳㼑㼚㼑㼞㼍㼘 㼞㼑㼝㼡㼕㼞㼑㼙㼑㼚㼠㼟 㠀άᛶ䛺እ⛉ⓗᇙ≀䇶⯡ⓗせồ㡯 㻙㻵㻿㻻 㻝㻜㻡㻡㻡㻙㻝㻦㻞㻜㻝㻟㻘 㻮㻿 㻱㻺 㻵㻿㻻 㻝㻜㻡㻡㻡㻙㻝㻦㻞㻜㻝㻟 㻙 㻵㼚㼠㼞㼍㼢㼍㼟㼏㼡㼘㼍㼞 㼏㼍㼠㼔㼑㼠㼑㼞㼟 䇵 㻿㼠㼑㼞㼕㼘㼑 㼍㼚㼐 㼟㼕㼚㼓㼘㼑㻙㼡㼟㼑 㼏㼍㼠㼔㼑㼠㼑㼞㼟 㻙 㻼㼍㼞㼠 㻝㻦 㻳㼑㼚㼑㼞㼍㼘 㻾㼑㼝㼡㼕㼞㼑㼙㼑㼚㼠㼟 䛔ᤞ䛶⁛ ⳦⾑⟶䜹䝔䞊䝔䝹䇵➨䠍㒊䠖⯡せồ㡯 ⏕≀ᏛⓗᏳᛶ 㻙 㻵㻿㻻 㻝㻜㻥㻥㻟㻙㻝㻦㻞㻜㻜㻥㻘 㻮㻿 㻱㻺 㻵㻿㻻 㻝㻜㻥㻥㻟㻙㻝㻦㻞㻜㻜㻥 䇵 㻮㼕㼛㼘㼛㼓㼕㼏㼍㼘 㼑㼢㼍㼘㼡㼍㼠㼕㼛㼚 㼛㼒 㼙㼑㼐㼕㼏㼍㼘 㼐㼑㼢㼕㼏㼑㼟 㻙㻼㼍㼞㼠 㻝㻦 㻱㼢㼍㼘㼡㼍㼠㼕㼛㼚 㼍㼚㼐 㼠㼑㼟㼠㼕㼚㼓 㼣㼕㼠㼔㼕㼚 㼍 㼞㼕㼟㼗 㼙㼍㼚㼍㼓㼑㼙㼑㼚㼠 㼜㼞㼛㼏㼑㼟㼟 ་⒪ᶵჾ䛾⏕≀Ꮫⓗホ౯䠉➨ 㻝 㒊䠖䝸䝇䜽䝬䝛䝆䝯䞁䝖䝥䝻䝉䝇䛻䛚䛡 䜛ホ౯ཬ䜃ヨ㦂 㻙㻱㻺 㻵㻿㻻 㻝㻜㻥㻥㻟㻙㻣㻦㻞㻜㻜㻤, BS EN ISO 10993-7:2008 㻙 㻮㼕㼛㼘㼛㼓㼕㼏㼍㼘 㻱㼢㼍㼘㼡㼍㼠㼕㼛㼚 㼛㼒 㻹㼑㼐㼕㼏㼍㼘 㻰㼑㼢㼕㼏㼑㼟 㻙 㻼㼍㼞㼠 㻣㻦 㻱㼠㼔㼥㼘㼑㼚㼑 㻻㼤㼕㼐㼑 㻿㼠㼑㼞㼕㼘㼕㼦㼍㼠㼕㼛㼚 㻾㼑㼟㼕㼐㼡㼍㼘㼟 ་⒪ᶵჾ䛾 ⏕≀Ꮫⓗホ౯䠉➨ 㻣 㒊䠖㓟䜶䝏䝺䞁⁛⳦ฎ⌮ṧ␃≀ 㻙་⒪ᶵჾ䛾〇㐀㈍ᢎㄆ⏦ㄳ➼䛻ᚲせ䛺⏕≀ᏛⓗᏳᛶホ౯䛾ᇶᮏⓗ⪃ 䛘᪉䛻䛴䛔䛶㻔 ᖹᡂ 㻞㻠 ᖺ 㻟 ᭶ 㻝 ᪥⸆㣗ᶵⓎ 㻜㻟㻜㻝 ➨ 㻞㻜 㻕 ↓⳦ᛶಖドỈ‽ 㻙 ISO 11135:2007, BS 㻱㻺 㻵㻿㻻 㻝㻝㻝㻟㻡㻙㻝㻦㻞㻜㻜㻣 㻙 㻿㼠㼑㼞㼕㼘㼕㼦㼍㼠㼕㼛㼚 㼛㼒 㻴㼑㼍㼘㼠㼔 㻯㼍㼞㼑 㻼㼞㼛㼐㼡㼏㼠㼟 䇵 㻱㼠㼔㼥㼘㼑㼚㼑 㻻㼤㼕㼐㼑 㻙 㻼㼍㼞㼠 㻝㻦 㻾㼑㼝㼡㼕㼞㼑㼙㼑㼚㼠㼟 㼒㼛㼞 㻰㼑㼢㼑㼘㼛㼜㼙㼑㼚㼠㻘 㼂㼍㼘㼕㼐㼍㼠㼕㼛㼚 㼍㼚㼐 㻾㼛㼡㼠㼕㼚㼑 㻯㼛㼚㼠㼞㼛㼘 㼛㼒 㼍 㻿㼠㼑㼞㼕㼘㼕㼦㼍㼠㼕㼛㼚 㻼㼞㼛㼏㼑㼟㼟 㼒㼛㼞 㻹㼑㼐㼕㼏㼍㼘 㻰㼑㼢㼕㼏㼑㼟 䝦䝹䝇䜿䜰〇ရ䛾⁛⳦䠉䜶䝏䝺䞁䜸䜻䝃䜲䝗䠉 ➨ 㻝 㒊䠖་⒪ᶵჾ䛾⁛⳦䝥䝻䝉 䝇䛾㛤Ⓨ䠈䝞䝸䝕䞊䝅䝵䞁ཬ䜃᪥ᖖ⟶⌮䛾せồ㡯 -ISO 11737-1:2006, BS EN ISO 11737-1:2006 - Sterilization of Medical Devices-Microbiological Methods Part 1: Determination of a Population of Microorganism on Products ་⒪ᶵჾ䛾⁛⳦íᚤ⏕≀Ꮫⓗ᪉ἲí➨ 1 㒊䠖〇 ရ䛾ᚤ⏕≀⩌䛾 ᐃ᪉ἲ -EN 556-1:2001 - Requirements for Medical Devices to be Designated “Sterile” – Part 1: Requirements for Terminally Sterilized Medical Devices ་⒪ᶵჾ䛻 “⁛⳦῭䜏”䛸䝷䝧䝹⾲♧䛩䜛䛯䜑䛾せồ㡯-➨䠍㒊䠖⤊ⓗ䛻⁛⳦䛥䜜䛯་ ⒪ᶵჾ䛾せồ㡯
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