Standards Development

Scope

This part of ISO 14644 specifies the minimum requirements for the design, construction, installation, test and setting to work of separative devices, in those respects where they differ from cleanrooms as described in ISO 14644-4.

It is intended to be complimentary to the requirements of other national and international standards and guidelines for separative devices as listed below.

This part includes devices providing segregation using either physical or aerodynamic separation for the purposes of preventing the ingress of contaminants to the device or preventing the egress of contaminants from the device. It provides design, testing and operational parameters to distinguish between devices with different purposes and performance characteristics.

Separative devices covered by this section addresses:

— Unidirectional Airflow Devices

— Material Handling Booths

— Restricted Access Barrier Systems (with or without access devices)

— Isolators (open or closed isolators, with or without transfer devices)

— Transfer Containers

— Biological Safety Cabinets Class II and III

— Gloveboxes

— Pass-Through Boxes or Transfer Hatches

— Minienvironments

Refer to Annex A for further information on the above devices.

This part of ISO 14644 excludes:

— Devices designed solely for containment, not associated with cleanrooms or clean zones.

— Environmental health or safety requirements which might drive the need for containment.

— Application-specific requirements

— Specific processes to be accommodated in the separative-device installation.

— Fire, safety and other regulatory matters, specifically where appropriate national and local regulations apply.