Non-Simulation Integrity Performance Tests

ISTA 1G is for packaged-products 150 lb. (68 kg) or less, and challenges the strength and robustness of the product and package combination to withstand transport hazards.

ISTA procedure 1G is similar to ISTA 1A. The primary difference is that the vibration method used for ISTA 1G is random, whereas 1A vibraton is fixed.

Test Procedure 1G is broken down into two categories: Vibration and Shock:

  • Vibration is random displacement that complies with ASTM D4728. Rotary or vertical linear motion of the platform is acceptable.
  • Shock testing is broken down into three test types: Drop, Incline-Impact (Conbur), and Horizontal Impact. Drop testing is a free fall test and complies with ASTM D5276. Incline-Impact (Conbur) testing complies with ASTM D880, and Horizontal Impact testing is in compliance with ASTM D4003.

When properly applied, ISTA procedure 1G will provide tangible benefits of:

  • Shortened packaged development time and confidence in product launch
  • Protection of products and profits with reduced damage and product loss
  • Economically balanced distribution costs
  • Customer satisfaction and continued business

ISTA Procedure 1G – Testing Sequence and Types:

Sequence Test Type Standard Description
1 Vibration ASTM D4728 Random Fixed Displacement
2 Drop ASTM D5276 Free Fall

    Membership is open to Manufacturers of Sterilisation products or related services, with sales in Europe. Affiliation is open to companies/trade associations/healthcare professionals who are Responsible Users of SBS or represent those that are. Potential members or affiliates also need to have implemented a quality management system certified by an accredited certification body.

    For more details see Why become a member?

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