Tag: packaging

New Amendment 2 for AAMI-ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities

AAMI ST79, “Comprehensive guide to steam sterilization and sterility assurance in health care facilities,” has just been modified by Amendment 2.  This is a 134 page amendment that makes corrections to the original text.

You have a choice when purchasing the document.  You can get the whole document as a corrected reprint with the corrections interfiled (included).  Or you can purchase the amendment 2 as a standalone item, making the pen and ink changes to your original copy manually.

The document itself covers steam sterilization in health care facilities. The recommendations are intended to promote assurance of sterility and to guide health care personnel in the proper use of processing equipment.

Included within the scope of AAMI-ST79 are functional and physical design criteria for sterilization processing areas (decontamination, preparation, sterilization, and sterile storage areas), staff qualifications, education, and other personnel considerations, processing procedures, installation, care, and maintenance of steam sterilizers, quality control, and quality process improvement.

Document Center provides AAMI standards via our website, www.document-center.com.  Or you can contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) to order copies.  Most AAMI standards are available in both paper and electronic format.

New ASTM D6251 – 11/D6251M – 11 Standard Specification for Wood-Cleated Panelboard Shipping Boxes

There’s a new 2011 revision for ASTM D6251/D6251M, “Standard Specification for Wood-Cleated Panelboard Shipping Boxes.”  The 16 page document covers the fabrication and closure of empty and full wood-cleated panelboard boxes (wooden crates).

Boxes are firstly classified according to box type: Type I, Type II, Type III, and Type IV.  Then they’re further segregated according to class: Class 1 and Class 2.  There’s additional classification for style:  Style A, Style A1, Style B, and Style C through K.  And also classification according to preservative treatment; Treatment A and Treatment B.  Then lastly, according to load type: Type 1, Type 2, and Type 3.

Panels using this standard are fabricated by nailing, stapling, or gluing panelboard to cleats.

Specified requirements are given for fastener component test, fastener test for securing cleats to panelboard panels, lateral resistance test, direct withdrawal resistance test, oxine copper preservative test, zinc napthenate preservative test, and preservative dryness test.

The specification has been adopted by the U.S. government as a replacement for the popular Federal specifications, PPP-B-576 (cancelled in 1998) and PPP-B-601 (cancelled in 1999).

ASTM D6251 and all ASTM standards can be purchased from Document Center Inc. at our website, www.document-center.com.  We have copies of the obsolete Federal Specifications as well.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We can assist you with all your standards questions and requirements.

New ASTM D3951 2010 Edition for Commercial Packaging released

ASTM D3951-98, Standard Practice for Commercial Packaging, has been revised with the release of the new 2010 Edition, ASTM D3951-10.  As you can see, this is the first revision of the standard in over 10 years.  It is one of Document Center’s most frequently ordered ASTM standards on packaging and is available now.

ASTM describes the standard as follows:  “(It)  covers the requirements for the commercial preservation, packaging, packing (exterior container), unitization, and marking for supplies and equipment. It provides for multiple handling and shipment by any mode, and storage periods of a minimum of one year in enclosed facilities without damage to the product. It also provides for package quantities suitable for redistribution without additional repackaging or marking. Planned storage that exceeds one year requires more than minimum requirements for physical and mechanical protection.”

You’ll want to know that this practice establishes minimum requirements for packaging of supplies and equipment as covered in Title 49 of the Code of Federal Regulations, with the exclusion of  ammunition, explosives, or hazardous materials.  It is also referenced for some Department of Defense shipments not covered by MIL-STD-2073/1.

Copies of this new ASTM D3951-10 may be purchased in paper or pdf format from Document Center Inc. at www.document-center.com, info@document-center.com, by phone at 650-591-7600 and by fax at 650-591-7617.

AAMI-ST79 – The new 2010 Edition is available for preorder now

The AAMI recommended practice ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, is now approved in a new 2010 Edition and public distribution is pending.

The standard consolidates 5 previous AAMI steam sterilization standards, the AAMI ST33, AAMI ST35, AAMI ST37, AAMI ST42 and AAMI ST46.  It was the first AAMI standard to be released in a binder edition, since the material covered is extensive.  The binder format facilitates easy access to the various topics, like lowering and limiting bioburden before sterilization, properly preparing items for sterilization, selecting the appropriate sterilization parameters, and establishing and implementing controls to maintain the sterility of sterilized items until they are used.

Users of this standard will find guidance to promote assurance of sterility and to guide health care personnel in the proper use of processing equipment.  The document includes functional and physical design criteria for a number of sterilization processing areas  including decontamination, preparation, sterilization, and sterile storage areas.  There are sections to assist with staff qualifications, education and other personnel considerations.  Also covered are  processing procedures,  installation, care and maintenance of steam sterilizers, quality control and, of course, quality process improvement.

The new ANSI/AAMI-ST79:2010 replaces the previous 2006 Edition with both Amendments 1 and 2, which is no longer available.  Because the new ANSI/AAMI-ST79 was only recently approved (9/3/2010), there will be a delay until the new edition is available.  Normal lag time can be from 1 to 3 months for the formatting and publishing functions to take place and the standard to become publicly available.

To purchase your copy of ANSI/AAMI-ST79, use our website at www.document-center.com, or call us at 650-591-7600, fax 650-591-7617, or email to info@document-center.com.

Your order can be placed now and shipped as soon as it is released.