VDI 2083 Blatt 21:2019-10

Cleanroom technology - Cleanliness of medical devices in the manufacturing process

German title: Reinraumtechnik - Reinheit von Medizinprodukten im Herstellungsprozess
Publication date: 2019-10
Original language: German, English
Pages: 108

Please select

from 219.10 EUR VAT included

from 204.77 EUR VAT excluded

Purchasing options

PDF download

Language: German, English
219.10 EUR

Shipment (3-5 working days)

Language: German, English
243.90 EUR

Standards Ticker ¹

Language: German, English

Learn more about the standards ticker

Online service subscriptions

This document also features in an online service. Online services not only give you electronic access to collections of standards, they contain lots of extra information too (such as directives, legal texts, commentaries, etc.). There are automatic updates on a regular basis – and online services also give you large savings compared with the cost of purchasing standards individually.

Suitable online services

Publication date: 2019-10
Original language: German, English
Pages: 108

Product information on this site:

Quick delivery via download or delivery service

Buy securely with a credit card or pay upon receipt of invoice

All transactions are encrypted

Short 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).

Content

ICS

13.040.35

Also available in

Loading recommended items...