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Industry Standards

ASTM Standards Update

Mike Yanke Mike

Updates have been made to the following ASTM standards:

D Category

D3103 - Standard Test Method for Thermal Insulation Performance of Distribution Packages has been revised (with title change) to D3103-07

D3518/D3518M - Standard Test Method for In-Plane Shear Response of Polymer Matrix Composite Materials by Tensile Test of a ±45° Laminate has been reapproved, available as D3518/D3518M-94(2007)

D3552 - Standard Test Method for Tensile Properties of Fiber Reinforced Metal Matrix Composites has been reapproved, available as D3552-96(2007)

D3953 - Standard Specification for Strapping, Flat Steel and Seals has been revised to D3953-07

ASTM Standards Update

Mike Yanke Mike

Updates have been made to the following ASTM standards:

D1749 - Standard Practice for Interlaboratory Evaluation of Test Methods Used with Paper and Paper Products has been reapproved, available as D1749-93(2007)

D1968 - Standard Terminology Relating to Paper and Paper Products has been reapproved, available as D1968-02a(2007)

D2019 - Standard Test Method for Dirt in Paper and Paperboard has been reapproved, available as D2019-97(2007)

D2043 - Standard Test Method for Silver Tarnishing by Paper has been reapproved, available as D2043-94(2007)

D2176 - Standard Test Method for Folding Endurance of Paper by the M.I.T. Tester has been reapproved, available as D2176-97a(2007)

DDL Expands Product/Material Testing Standards List

John Hart John

DDL has updated its product and material testing standards list.  View DDL’s industry standards page to see a comprehensive list of all test standards that DDL complies with throughout its testing procedures.

Pending Revisions to ISO 4180

Patrick Nolan Patrick

I recently met with the Technical Committee 122 to discuss the proposed changes to ISO 4180 - “Packaging-Complete, filled transport packages-General rules for the compilation of performance test schedules.”

The objective of this meeting was to review the draft document developed from discussions during the first meeting in June 2005.

In the previous meeting, the Working Group had agreed on the structure of combining the two parts of the current standard into a single document.

The ensuing discussion revolved around the proposed 2nd draft of the revised standard. Some of the highlights of the proposed draft are presented below and revolved around the Test Schedule Tables.

ASTM Standards Update

Karen Sams Karen

Updates have been made to the following ASTM standards:

ASTM D 4332-01 - Standard Practice for Conditioning Containers, Packages or Packaging Components for Testing

ASTM D 6653-01 - Standard Test Methods for Determining the Effects of High Altitude On Packaging Systems By Vacuum Method

Updates to IEC Standards

Karen Sams Karen

Updates have been made to the following IEC industry standard:

IEC 60601-1-8 Ed. 2.0 (2006-10) Preview Price: CHF 237.00
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Read about the updated IEC 60601 standard.

Updates to IEC Standards

Melinda Melinda

Withdrawn & Replaced

The following IEC Standards have been withdrawn:

IEC 60118-11 Ed. 1.0 1983 TC# 29

IEC 60601-2-9 Ed. 2.0 1999 TC# 62C

IEC 60655 Ed. 1.0 1979 (TC# 29) has been replaced with IEC 61094-7 Ed. 1.0 2006

Just Published

The following IEC Standards have just been published:


IEC DICT Ed. 6.0 (2005-02)
Price: CHF 295.00
IEC Multilingual Dictionary on CD-ROM - 6th edition

ISO/IEC 10118-2 Ed. 2.0 (2006-09)
Corrigendum 1 - Information technology - Security techniques - Hash-functions - Part 2: Hash-functions using an n-bit block cipher

The New ISO 11607-01 Standard Impacts Package Validation

Karen Sams Karen

ISO 11607, the foremost guidance document for validating packaging for terminally sterilized medical devices, has been revised.  The new ISO 11607-01 standard contains new compliance requirements for medical device manufacturers and package engineers.

Clause 6 is the most affected part of the standard.  This is the clause that addressses the package’s ability to deliver a medical device to the patient without jeopardizing sterility or incurring defect.  An entire section has been added to Clause 6 to address the requirements for sterile fluid pathways.

The revisions to ISO 11607 also affect the following:

  • Test Methods
  • Sampling Plans