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TECHNICAL SPECIFICATION. SPÉCIFICATION TECHNIQUE. TECHNISCHE SPEZIFIKATION. CEN ISO/TS 16775. May 2014. ICS 11.080.30. English Version.
Språk: en. Erstatter A00008:20:044278. Rapporter fra CEN (CR). ISO/TS 16775, Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2. CEN ISO/TS 16775, Kungl. Maj:ts nådiga proposition till Riksdagen med förslag till ioo — iso; — hela riket på hvarje kommun belöpte i medeltal 16,775 fyrkar, var medel -. 64.
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% av TS. 0. Glödgningsrest mg/l. 227. 0. 0. 129. 141.
7 Nov 2017 For further guidance, see. ISO/TS 16775:2014, Annex L. 4.4 Test methods. 4.4.1 A rationale for the selection of appropriate tests for the packaging
1. 17163. 203 SKOUN.
The latest revision of ISO 11607-1/2: 2019, “Packaging for terminally sterilized medical devices,” was just published in February 2019, and ISO TS 16775, the
Rapporter fra CEN (CR). ISO/TS 16775, Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2. CEN ISO/TS 16775, Kungl. Maj:ts nådiga proposition till Riksdagen med förslag till ioo — iso; — hela riket på hvarje kommun belöpte i medeltal 16,775 fyrkar, var medel -. 64. Fältutförande.
It does not provide guidance for applications of packaging materials and systems after their opening. In the use of packaging for other purposes such as a "sterile field" or transport of contaminated items, other regulatory standards will apply.
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ISO/TS 16775:2014 provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. It does not add to, or otherwise change, the requirements of ISO 11607-1 and/or ISO 11607-2.
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Updates to ISO 11607 and ISO TS 16775, standards covering packaging for terminally sterilized medical devices, may help manufacturers comply with EU Medical Device Regulation set to go into effect next year. With an application date of May 2020, the new EU Medical Device Regulation (MDR) is fast coming down the pike—a daunting prospect for medical
s. Iso Löytänenjärvi i d:o. Foto: filmnr 93S ISO, 93S 151, 930 I 15. MlQ. utgår (sorkbo) 16775/46840 (16776/46841).
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ISO/TS 16775:2014. NOK 2 133,00 (eks Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
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