VDI 2083 Blatt 16.1-2010
Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification

Standard No.

VDI 2083 Blatt 16.1-2010

Release Date

2010

Published By

Association of German Mechanical Engineers

Latest

VDI 2083 Blatt 16.1-2010

Replace

VDI 2083 Blatt 16-2009

Scope

This guideline provides guidance for the planning, manufacture/installation, commissioning and operation of barrier systems in contamination control. Planer, manufacturer and user of clean environments must define, and lay down in writing, the requirements to be met by the product and its environment. The scope of this guideline includes any type of barrier between the room and the process environment, which serves for contamination control, expressly including dynamic (flow) as well as solid barriers. All types of contamination (particulate, chemical/molecular, biological) are included. The guideline supplements DIN EN ISO 14644-7 in practical aspects.

VDI 2083 Blatt 16.1-2010 Referenced Document

• DIN 12980:2005 Laboratory furniture - Safety cabinets for handling cytotoxic substances
• DIN EN 12469:2000 Biotechnology - Performance criteria for microbiological safety cabinets; German version EN 12469:2000
• DIN EN 14175-1:2003-08 Fume cupboards - Part 1: Vocabulary; German version EN 14175-1:2003
• DIN EN 14175-2:2003-08 Fume cupboards - Part 2: Safety and performance requirements; German version EN 14175-2:2003
• DIN EN 14175-3:2004 Fume cupboards - Part 3: Type test methods; German version EN 14175-3:2003
• DIN EN 14175-4:2004-12 Fume cupboards - Part 4: On-site test methods; German version EN 14175-4:2004
• DIN EN 14175-6:2006-08 Fume cupboards - Part 6: Variable air volume fume cupboards English version of DIN EN 14175-6:2006-08
• DIN EN 1779:1999 Non-destructive testing - Leak testing - Criteria for the method and technique selection; German version EN 1779:1999
• DIN EN 374-2:2003 Protective gloves against chemicals and micro-organisms - Part 2: Determination of resistance to penetration; German version EN 374-2:2003
• DIN EN 374-3:2003 Protective gloves against chemicals and micro-organisms - Part 3: Determination of resistance to permeation by chemicals; German version EN 374-3:2003
• DIN EN 420:2003 Protective gloves General requirements and test methods
• DIN EN 61511-1:2005 Functional safety - Safety instrumented systems for the process industry sector - Part 1: Framework, definitions, system, hardware and software requirements (IEC 61511-1:2003 + Corrigendum 2004); German version EN 61511-1:2004
• DIN EN ISO 14644-7:2005 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004); German version EN ISO 14644-7:2004

VDI 2083 Blatt 16.1-2010 history

• 2010 VDI 2083 Blatt 16.1-2010 Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification
• 2009 VDI 2083 Blatt 16-2009 Reinraumtechnik - Barrieresysteme (Isolatoren@ Mini-Environments@ Reinraummodule) - Wirksamkeit und Zertifizierung

VDI 2083 Blatt 16.1-2010 Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification has been changed from VDI 2083 Blatt 16-2009 Reinraumtechnik - Barrieresysteme (Isolatoren@ Mini-Environments@ Reinraummodule) - Wirksamkeit und Zertifizierung.