Standards Development

Scope

This standard gives recommendations and guidance for the development of recycled plastic materials for use in laboratory and medical products.

It covers critical stages in the development of such materials for use in laboratory and medical products, including:

•           recycling, including sourcing, collection, segregation, decontamination and purification;

•           quality management and risk management of the recycling process; and

•           material specifications, including extractables, leachables, traceability and mechanical properties.

This standard does not cover general recommendations for recycled plastics or non-medical/lab-based applications. Additionally, it does not include recommendations for the manufacturing of medical devices or laboratory equipment crafted from recycled plastics, nor does it cover the use of materials other than plastics.

This standard is of use to:

•           manufacturers of medical devices;

•           manufacturers and suppliers of recycled plastic materials;

•           testing laboratories;

•           quality assurance and regulatory affairs professionals; and

•           compliance officers in the laboratory and medical product sectors. 

This standard might be of interest to:

•           waste management operators;

•           manufacturers looking to use recycled plastics;

•           healthcare professionals;

•           researchers who develop new materials and processes;

•           researchers who require reliable and safe materials for their work;

•           sustainability certification bodies;

•           regulators; and

•           procurers on behalf of the public sector.