Standard Specification for Polyethylene Plastics for Medical Applications Ingestion-build-225643 NOTE 1 Non-contact measurement techniques

NOTE 1 Non-contact measurement techniques are discussed in Annex D

specifies the safety requirements and their verification for the design and construction of mounted

It covers such topics as leadership

Spain (IRANOR) and Italy (UNI)

in response to calls from the industry for best practice guidance

Standard Specification for Polyethylene Plastics for Medical Applications Ingestion-build-225643 NOTE 1 Non-contact measurement techniques1. Scope 1. 1 This specification covers polyethylene plastics (as defined in Terminology D883) intended for use in medical device applications involving human tissue contact devices, short term indwellings of 30 days or less, and fluid transfer devices. The biocompatibility of these materials as a class has not been established. Biocompatibility tests must be conducted on the final product.