Non-Simulation Integrity Performance Tests

ISTA 1A 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. Procedure 1A is useful particularly when used as a consistent benchmark over time.

Many medical device manufacturers use ISTA Procedure 1A. This procedure was developed for a quick and easy way to evaluate a shipping configuration for drop testing and repetitive shock vibration. This procedure does not take into a account random vibration or atmospheric pre-conditioning.

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

  • Vibration is fixed displacement that complies with ASTM D999. 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 1A 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 1A – Testing Sequence and Types:

Sequence Test Type Standard Description
1 Vibration ASTM D999 Fixed Displacement, Rotary, Vehicle Linear Motion
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.

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