T/CNPPA 3002―2018 Active Group standards

T/CNPPA 3002―2018 Technical guidelines for the packaging system of peritoneal dialysis solution

Publish Date: 2018-07-20 Implement Date: 2018-07-20 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: Medical equipment

Publish Date: 2018-07-20

Implement Date: 2018-07-20

Pages: 16 pages

Scope

1.1 This guideline specifies the terms and definitions of peritoneal dialysis solution packaging systems, structural examples and functional descriptions of each component, design requirements, production quality management, storage and packaging expiration dates of packaging materials and components, transportation requirements, functional and safety requirements, labeling and user manual requirements. 1.2 This guideline applies to peritoneal dialysis solution packaging systems made of various materials. Currently, materials used in peritoneal dialysis solution packaging systems include polyvinyl chloride, polyolefins, polycarbonates, and rubber. 1.3 This guideline applies to various types of peritoneal dialysis solution bags. Packaging systems are divided into single-bag and dual-bag types according to their usage; solution bags are divided into single-chamber bags and multi-chamber bags according to their structure. 1.4 This guideline applies to peritoneal dialysis solution packaging systems of various specifications.