YY/T 0681.15-2019Test methods for sterile medical device package - Part 15: Performance testing of shipping containers and systems (English PDF)

Foreword

YY/T 0681 "Test methods for sterile medical device package" consists of the following parts.

-- Part 1: Test guide for accelerated aging;

-- Part 2: Seal strength of flexible battier materials;

-- Part 3: Internal pressurization failure resistance of unrestrained packages;

-- Part 4: Detecting seal leaks in porous packages by dye penetration;

-- Part 5: Detecting gross leaks in medical packaging by internal pressurization (bubble test);

-- Part 6: Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials;

-- Part 7: Evaluating inks or coating adhesion to flexible packaging materials using tape;

-- Part 8: Coating/adhesive weight determination;

-- Part 9: Burst testing of flexible package seals using internal air pressurization weight restraining plates;

-- Part 10: Test for microbial barrier ranking of porous package material;

-- Part 11: Determining integrity of seals for medical packaging by visual inspection;

-- Part 12: Flex durability of flexible barrier films;

-- Part 13: Slow rate penetration resistance of flexible barrier films and laminates;

-- Part 14: Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air;

-- Part 15: Performance testing of shipping containers and systems;

-- Part 16: Test for climatic stressing of packaging system. This Part is Part 15 of YY/T 0681.

This Part was drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This Part of YY/T 0681 specifies a uniform method for evaluating the ability of sterile medical device shipping units to withstand the transport environment in the laboratory.

This Part is used for guiding the user to design an appropriate test plan, so that the shipping unit can withstand a series of expected hazards to be experienced in a specific distribution cycle.

This Part does not include performance testing of single parcel transport packages.

2 Normative references

The following documents are indispensable for the application of this document.

For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 4857.2, Packaging - Basic tests for transport packages - Part 2. Temperature and humidity conditioning

GB/T 4857.4, Packaging - Basic tests for transport packages - Part 4. Compression and Stacking tests using a compression tester

GB/T 4857.5, Packaging - Transport packages - Vertical impact test method by dropping

GB/T 4857.7-2005, Packaging - Basic tests for transport packages - Part 7. Sinusoidal vibration test method at constant frequency

3 Terms and definitions

The following terms and definitions are applicable to this document.

4 Test schedule applicable to the distribution cycle of sterile medical devices .

4.2 The schedule which is given in Table 1 simulates the various hazards that the medical device is expected to experience during the transportation test. The test schedule is expected to be used in the following areas.

4.3 These tests should be carried out sequentially on the same shipping unit.

5 Test sample

5.1 The test sample consists of representative and complete samples of the shipping unit, including the actual contents. For valuable medical devices, if there is no need to conduct experimental research on the defects of the contents, and the defects have been recorded in the report, products of flaws or small defects can be used.

5.2 It shall be ensured that the product and packaging are not degraded when the test package arrives at the test site.

5.3 The number of tests performed depends on the intended purpose of the test and the availability of the same product and shipping container.

6 Conditioning and test

The samples shall be tested under standard atmospheric conditions; the influence of any climatic conditions shall be compensated. Unless other temperature and relative humidity conditions are considered more appropriate, the shipping unit shall be placed in the standard atmosphere, where the temperature is (23±2) °C and the relative humidity is (50±2) %, as specified in

GB/T 4857.2, for conditioning.

7 Acceptance criteria

7.1 Acceptance criteria shall be established before the test; the required state of the product should be considered when it is received. The organization that conducts the test can choose any acceptance criteria that suits its purpose.

7.2 In most cases, the acceptance criteria can be.

8 Procedure

9 Test schedule corresponding to the hazard

The test schedule corresponding to the hazard is shown in Table 2.