YY/T 0884-2013 (English Version) PDF

Scope: This standard provides procedures and information for evaluating the suitability of the constituent materials of health care products (including packaging), including polymer materials, metals, ceramics/glass and other materials, for radiation sterilization processing, providing a basis for the selection and identification of health care products and Provides guidance on packaging materials.

YY/T 0884-2013 Referenced Document

GB/T 1040 Plastics-Determination of tensile properties
GB/T 1041-2008 Plastics.Determination of compressive properties
GB/T 13525 Test method for tensile-impact property of plastics
GB/T 16578.1-2008 Plastics.Film and sheeting.Determination of tear resistance.Part 1:Trouser tear method
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
GB/T 2410-2008 Determination of light transmittance and haze of transparent plastics
GB/T 2411-2008 Plastics and ebonite.Determination of indentation hardness by means of a durometer(shore hardness)
GB/T 3398.2-2008 Plastics.Determination of hardness.Part 2:Rockwell hardness
GB/T 9341-2008 Plastic.Determination of flexural properties
HG/T 3862-2006 Plastics. Test method of yellowness index
ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

2013 YY/T 0884-2013 Evaluation of materials of health care product subject to radiation sterilization