Dear Sirs,

we are importers and distributors of medical equipment into Mexico.
We would like to know if there are special norms or requirements for shelving for Sterile Storage Areas.

We will appreciate any reference regarding this matter.

Best regards,

Alberto Castillejo G.
ALTAespecialidad Mexico, S.A. de C.V.
Tel/Fax: (5255) 5234-7373 & 5234-7575
Mexico, D.F.

General standards for shelving sterile supply includes protection of the contents, ease of stock rotation and ease of cleaning.

Central storage of sterile supplies is commonly on carts, fixed wall shelving or ideally mobile shelving with smooth surfaces and angles to prevent damage.

Both open and closed shelving system are used. Sterile material should be stored above floor level at least 250 mm and from ceiling fixtures by at least 440 mm, and protected from direct sunlight. Temperature within the storage area should range from 22°C to 24°C with a relative humidity not lower than 35% (with 50% the ideal). The storage room must be a separate, limited- access area with airflow out of the storage room (via positive pressure). The only function of this room has to be storing sterile supplies.

A good reference is the Book or new CD "National Standards and Recommended Practices for Sterilisation" from the Association for Advancement of Medical Instrumentation (AAMI), Arlington, Virginia.

Kind regards
Josy Holdener

There are some regulations worldwide, and a few special for the Netherlands.
Those rules are:

• easy to clean materials
• distance floor to first bare [or module] at least 30cm
• smooth edges

Futhermore there are more regulations about the room-conditions:

• 18 degrees C
• no daylight
• clean area (covered roof)
• no watertap-points
• restrickted area
• no transport boxes/pack.

Etc.

Please also see: www.medi-math.com and www.h-link.org

Yours sincerely,
Bert Berrens


www.medi-math.com