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VDI 2083 BLATT 21

Cleanroom technology - Cleanliness of medical devices in the manufacturing process

active, Most Current
Organization: VDI
Publication Date: 1 October 2019
Status: active
Page Count: 108
ICS Code (Cleanrooms and associated controlled environments): 13.040.35

Document History

January 1, 2020
Cleanroom technology - Particulate air cleanliness classes
A description is not available for this item.
VDI 2083 BLATT 21
October 1, 2019
Cleanroom technology - Cleanliness of medical devices in the manufacturing process
A description is not available for this item.
August 1, 2018
Cleanroom technology - Tightness of containments - Classification, planning and testing
A description is not available for this item.
June 1, 2018
Cleanroom technology - Determination of the desorption kinetics of materials after fumigation
A description is not available for this item.
January 1, 2017
Cleanroom technology - Consumables in the cleanroom
This standard is applicable to all consumables used in clean controlled environments. Examples include: • gloves • multiple-use clothing • cleanroom shoes/overshoes • packaging materials • wipes...
October 1, 2015
Cleanroom technology - Ultrapure media - Quality, supply, distribution
A description is not available for this item.
April 1, 2015
Cleanroom technology - Stipulations regarding the checking and monitoring of continued compliance with specifications
This standard specifies requirements regarding periodic checking of a cleanroom or controlled environment for demonstrating continued compliance. These requirements refer to the functional tests...
October 1, 2014
Cleanroom technology - Air cleanliness chemical concentration (ACC)
This standard deals with the control and determination of chemical contamination in cleanrooms in order to protect process, product and personnel. It specifies general principles for the treatment,...
June 1, 2013
Cleanroom technology - Compatibility of materials with the required cleanliness
In essence, the present guideline deals with particulate, chemical (molecular) emissions and electrostatic characteristics of materials and the cleanability of material surfaces. Biological and...
January 1, 2013
Cleanroom technology - Particulate air cleanliness classes
Guideline VDI 2083 Part 1 contains, in terms of formulae, tables and graphs, the classification of air cleanliness in cleanrooms and associated controlled environments. This guideline exclusively...
June 1, 2012
Cleanroom technology - Metrology in cleanroom air - Monitoring
This guideline applies to the ongoing, system-specific monitoring of individual parameters of cleanroom systems. Monitoring may be continuous (e. g. for pressure, temperature, humidity) or sequential...
January 1, 2012
Cleanroom technology - Biocontamination control
Microbial contaminants on surfaces and in the air (including cleanroom air), as addressed by this guideline, include all microorganisms capable of proliferation (bacteria and their spores, fungi and...
April 1, 2011
Cleanroom technology - Energy efficiency
This guideline focuses on the cleanroom-specific energy- saving potentials. The running processes in the cleanroom are considered but at their interfaces with cleanroom-specific building services...
October 1, 2010
Cleanroom technology - Quality, production, and distribution of ultrapure water - Pharmacy and other life-science applications
The scope of VDI 2083 Part 13.1 applies.
August 1, 2010
Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification
This guideline deals with all types of barrier systems for the separation of defined clean environments. The objective includes: classification of contaminants – from the viewpoint of hazard...
January 1, 2009
Cleanroom technology - Quality, production and distribution of ultrapure water - Microelectronics and other technical applications
This guideline aims to compile the existing expertise regarding the planning, construction, operation and monitoring of water-processing installations for the production of ultrapure water. It...
January 1, 2009
Cleanroom technology - Quality, production and distribution of ultrapure water - Fundamentals
This guideline aims to compile the existing expertise regarding the planning, construction, operation and monitoring of water-processing installations for the production of ultrapure water. It...
October 1, 2008
Cleanroom technology - Cleanroom operation - Decontamination of multiple-use cleanroom clothing
This guideline applies to cleanroom clothing intended for repeated use. Single-use cleanroom clothing that is disposed of after use is not the subject of this guideline. The requirements and the...
January 1, 2008
Cleanroom technology - Quality assurance
In the guidelines of the VDI 2083 series, cleanliness classes are defined for the design, construction and operation of clean facilities, and ways for achieving and observing these classes are...
September 1, 2007
Cleanroom technology - Cleanroom operation
This guideline describes requirements with respect to the operation of contamination control systems, which are specified within a quality management system to ensure compliance of the process...
April 1, 2007
Cleanroom technology - Personnel at the clean work place
Scope of application Guideline VDI 2083 Part 15 covers the requirements for personnel and their clothing in relation to the cleanroom. Furthermore, indications on training for behaviour in the...
December 1, 2006
Clean room technology - Compatibility with required cleanliness and surface cleanliness
This VDI guideline essentially deals with particulate contamination. Chemical (molecular), biological and radiological surface contamination is not a specific issue in this guideline; the same holds...
November 1, 2006
Cleanroom technology - Cleanliness of process media
The cleaning of process media is an element of clean processing. The level of cleanliness of process media depends on a multitude of potential contamination sources. This part of the guideline VDI...
October 1, 2006
Cleanroom technology - Planning, construction and start-up of cleanrooms
This guideline describes the systematic approach for large-scale new construction projects as well as for extension, remodelling and renovation projects and for the installation of new equipment. The...
July 1, 2005
Cleanroom technology - Metrology and test methods
General Separate standards or VDI guidelines apply to the testing of individual elements of cleanroom installations; examples are DIN EN ISO 14644-3, DIN EN ISO 14644-1, VDI 2083 Part 1, VDI 2083...
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