T/CNPPA 3002-2018 Active Group standards

T/CNPPA 3002-2018 Technical Guidelines for Peritoneal Dialysis Solution Packaging Systems

T/CNPPA 3002-2018

Publish Date: 2018-07-31 Implement Date: 2018-07-31 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
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Basic Information

Standard Code: T/CNPPA 3002-2018
Standard Type: Group standards
Standard Status: Active
is_force_gb: no
CCS Name: Mechanical Integration
ICS Name: Integrated medical science and healthcare devices
Publish Date: 2018-07-31
Implement Date: 2018-07-31

Scope

Main technical content: Peritoneal dialysis, as an effective method of blood purification, is characterized by simple operation, low medical cost, and easy popularization and application. It plays an irreplaceable role in improving the survival rate of uremia patients in China. Due to the characteristics of peritoneal dialysis treatment itself, its dependence on the packaging system is relatively high, so the packaging system has a significant impact on the drug quality of peritoneal dialysis solution and the treatment effect of patients. This guideline aims to guide enterprises to continuously improve from design and R&D, production, quality control, technical requirements, compatibility studies to storage and transportation. Production units and user units should provide sufficient guidance on product use to ensure patient medication safety, improve patient operation convenience, and enhance patients' quality of life.

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