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Pre-standard

ISO/TS 11796

Biological evaluation of medical devices - Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
Edition 2023-07

Pre-standard

ISO/ASTM TS 52930

Additive manufacturing - Qualification principles - Installation, operation and performance (IQ/OQ/PQ) of PBF-LB equipment
Edition 2021-11

Pre-standard

ISO/TS 19930

Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10⁻⁶
Edition 2017-12

Draft pre-standard

ISO/ASTM DTS 52949

Additive manufacturing of metals - Qualification principles - Installation, operation and performance (IQ/OQ/PQ) of PBF-EB equipment
Edition 2024-05

Die ISO 14000-Serie und ihre Umsetzung
Edition 2015-12

DIN EN ISO 22000 in der Praxis
Edition 2020-04

Hinweise von ISO/TC 176 - Deutsche Übersetzung der englischsprachigen Buches "ISO 9001:2015 for Small Enterprises - What to do?"
Edition 2017-06

Normentext, Erläuterungen, Ergänzungen, Musterformulare
Edition 2016-04

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