VDI 2083 Part 21:2019 Edition

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Cleanroom technology – Cleanliness of medical devices in the manufacturing process

Published By	Publication Date	Number of Pages
DIN	2019-10	108

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Categories: 13.040.35 - Cleanrooms and associated controlled environments, DIN

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Description

This standard is a pracitcal aid based on a risk-based approach to identifying critical biological, chemical or particulate contaminations and, if required, to the specification of acceptance criteria (assessment of cleanliness) and for the verification (determination of cleanliness) of medical products in the production process. This applies both to the medical products themselves and to their intermediates, supplier products, etc. This standard does not cover the initial treatment and reconditioning of medical products by the user and the assessment of biological compatibility of medical products (biocompatibility as per series of standards ISO 10993).

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2019-10
Pages Count	108
Language	Germany
Descriptors	Acceptance, Check lists, Clean rooms, Clean-room technology, Definitions, Evaluations, Examination (quality assurance), Impurities, Medical devices, Medical products, Medical technology, Prevention of pollution, Production, Purity requirements, Purity test, Risk, Specification (approval), Testing
File Size	3.0 MB
ICS Codes	13.040.35 - Cleanrooms and associated controlled environments

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VDI 2083 Part 21:2019 Edition

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