GB/T 15593-2020 in English
VALIDPlasticized poly(vinyl chloride) compounds for transfusion (infusion) equipment
- Issued on:2020-11-19
- Implemented on:2021-10-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$214.00
Introduction
Standard Evolution and Core Changes
| Comparison Dimensions | 1995 Edition | 2020 Edition |
|---|---|---|
| Standard Name | Soft Polyvinyl Chloride Plastics | Polyvinyl Chloride Plastics |
| Plasticizer Requirements | Only DEHP is specified | Add Non-phthalate Plasticizer Appendix |
| Biological Evaluation | Fixed 7 Tests | Dynamic Selection According to GB/T 16886 |
Analysis of key technical requirements
Material safety control
Article 3.1 of the standard clearly stipulates: It is prohibited to add substances that have not been toxicologically evaluated, and formula changes must be verified by the user. Special reminder of the reproductive toxicity risk of DEHP plasticizers, it is recommended to use alternatives such as epoxidized soybean oil.
Performance indicator upgrade
Typical case: Blood bag products have added low temperature impact embrittlement temperature detection (Table 1) to ensure the stability of materials under -80℃ freezing conditions.
Innovation in test methods
- Dual hardness system: Added Shore D hardness test (4.3.2) to cover a wider hardness range
- Biological evaluation changes: Cancel fixed test items and adopt GB/T 16886.1 risk management model
- Metal migration control: Added limits for 12 metals including aluminum and mercury (Table 2)
Implementation suggestions
- Establish an evaluation process for non-phthalate plasticizers and conduct alternative research with reference to Appendix A
- Improve the raw material traceability system to meet the material traceability requirements in Article 3.1
- Customize the biological evaluation plan according to the product use and keep complete verification records
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