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Meditsiiniseadmete bioloogiline hindamine. Osa 17: Aine eraldumise lubatud piirmäärade kehtestamine
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
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English
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13.22 EUR |
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Meditsiiniseadmete bioloogiline hindamine. Osa 18. Materjalide keemiline iseloomustus
Biological evaluation of medical devices - Part 18: Chemical characterization of materials
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English
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Valid |
11.67 EUR |
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Meditsiinivahendite bioloogiline hindamine. Osa 4: Vastasmõjude hindamiseks läbiviidavad valikkatsed verega
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
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English
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16.10 EUR |
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Meditsiinivahendite bioloogiline hindamine. Osa 5: Katsed tsütotoksilisuse hindamiseks - in vitro meetodid
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
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English
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15.40 EUR |
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Meditsiinivahendite bioloogiline hindamine. Osa 6: Katsed implantatsioonijärgsete paiksete toimete hindamiseks
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
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English
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12.51 EUR |
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Meditsiiniseadmete bioloogiline hindamine. Osa 7: Jäägid etüleenoksiidiga steriliseerimisest
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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English
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22.15 EUR |
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Meditsiiniseadmete bioloogiline hindamine. Osa 7: Jäägid etüleenoksiidiga steriliseerimisest
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1
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English
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Valid |
0.00 EUR |
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Meditsiiniseadmete bioloogiline hindamine. Osa 9: Potentsiaalsete lagusaaduste identifitseerimise ja kvantifitseerimise raamistik
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
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English
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Withdrawn |
8.01 EUR |
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Meditsiiniseadmete steriliseerimine. Etüleenoksiid. Osa 1: Nõuded meditsiiniseadmete steriliseerimise protsessi väljatöötamiseks, usaldusväärsuse kontrollimiseks ja rutiinseks kontrollimiseks
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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English
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18.00 EUR |
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Tervishoiutoodete steriliseerimine. Kiirgus. Osa 1: Nõuded meditsiiniseadmete steriliseerimisprotsessi väljatöötamisele, valideerimisele ja tavakontrollile (ISO 11137-1:2006)
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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16.10 EUR |
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Tervishoiutoodete steriliseerimine. Kiirgus. Osa 2: Steriliseerimisdoosi määramine (ISO 11137-2:2012)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
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English
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20.74 EUR |
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Bioloogilised süsteemid sterilisaatorite ja sterilisatsiooniprotsesside katsetamiseks. Osa 2: Spetsiaalsüsteemid kasutamiseks etüleenoksiidsterilisaatorites
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
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English
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6.47 EUR |
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Bioloogilised süsteemid sterilisaatorite ja sterilisatsiooniprotsesside katsetamiseks. Osa 3: Spetsiaalsüsteemid kasutamiseks niiske kuumusega steriliseerivates sterilisaatorites
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
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English
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8.01 EUR |
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Tervishoiutoodete steriliseerimine. Keemilised näitajad. Osa 1: Üldised nõuded
Sterilization of health care products - Chemical indicators - Part 1: General requirements
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13.92 EUR |
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Terminaalselt steriliseeritud meditsiiniseadmete pakendid. Osa 1: Nõuded materjalile, steriilsele kaitse- ja pakendamismeetoditele
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
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English
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13.22 EUR |
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Meditsiiniseadmete steriliseerimine. Mikrobioloogilised meetodid. Osa 1: Mikroobse populatsiooni määramine tootel
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
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English
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Valid |
16.10 EUR |
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Meditsiiniseadmete steriliseerimine. Mikrobioloogilised meetodid. Osa 1: Mikroobse populatsiooni määramine tootel
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
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English
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Valid |
0.00 EUR |
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Meditsiiniseadmete steriliseerimine. Mikrobioloogilised meetodid. Osa 2: Steriilsuskatsed steriliseerimisprotsessi määratlemisel, valideerimisel ja rakendamisel
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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English
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Valid |
11.67 EUR |
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Tervishoiutoodete aseptiline töötlemine. Osa 1: Üldnõuded (ISO 13408-1:2008)
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)
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English
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Valid |
18.00 EUR |
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Tervishoiutoodete aseptiline töötlemine. Osa 2: Filtreerimine (ISO 13408-2:2003)
Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
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English
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Valid |
10.19 EUR |