Transport Simulation Testing for Medical Device Packaging

Simulated Transportation Testing Standards for Sterile Medical Device Packaging

Final Simulated Transportation Testing Standards for Sterile Medical Device Packaging

1. FDA-recognized transportation testing standards:

- astm d4169

- ISTA 3A

- ISTA 3B

- ISTA 3E

2. Recommended standards for packaging transportation verification under GB/T 19633.1 (Packaging for terminally sterilized medical devices):

- GB/T 4857.17

- ASTM D4169

- ISTA Series 1, 2, and 3

3. Recommended standards under ISO 11607-1:

- ASTM D4169

- ISTA 3A & 3B

- ISTA 4A & 4B

- ISTA 7D

- ISO 4180

4. Standard in YY/T 0681 for sterile medical device packaging:

- YY/T 0681.15

5. Recommendations for Standard Selection:

- For domestic registration:

Prioritize YY/T 0681.15 and GB/T 4857.

Secondary options: ASTM D4169, ISTA 3A, ISTA 3B, ISTA 3E.

- For FDA and CE registration:

Recommended standards: ASTM D4169, ISTA 3A, ISTA 3B, ISTA 3E.

- For both domestic and FDA/CE registration:

Prioritize ASTM D4169.

Secondary options: ISTA 3A, ISTA 3B, ISTA 3E.

- For packaging validation:

Recommended: YY/T 0681.15, ASTM D4169, GB/T 4857.

> Note: YY/T 0681.15 refers to DC13 in ASTM D4169-16, considered the most stringent challenge representative of the domestic circulation of sterile medical device packaging.

6. Scope of Application for Each Standard:

- ISTA 3A (≤70kg):

Applicable to individual product packaging (single parcel), suitable for courier/parcel transportation.

- ISTA 3B:

Applicable to any form of packaging, suitable for LTL (Less-Than-Truckload) transportation.

- ISTA 3E:

Applicable to aggregated product packaging, suitable for any transportation form.

- ASTM D4169:

Covers 18 types of packaging and transportation methods, generally applicable to all commonly used scenarios.

- YY/T 0681.15:

Specifically for sterile medical device packaging.

In the global market, transportation testing of medical device packaging is not only a regulatory obligation but also a vital process to ensure product safety and efficacy. A scientifically sound simulated transportation validation is essential for quality control throughout the product lifecycle.

China JJR Laboratory, as a professional third-party testing organization, provides standardized testing services across multiple regulatory frameworks. We help companies meet domestic and international market entry requirements, reduce circulation risks, and accelerate the compliance process.