T/FDSA 023-2021 Low-temperature steam formaldehyde sterilization indicator packaging bag general technical standard
T/FDSA 023-2021 Low-temperature steam formaldehyde sterilization indicator packaging bag general technical standard
Basic Information
Scope
Scope: This document specifies the definition and composition of low-temperature steam formaldehyde sterilization indicator packaging bags, their requirements, test methods, marking, labeling, and user manuals, as well as their packaging, transportation, and storage. This document applies to low-temperature steam formaldehyde sterilization indicator packaging bags with printed chemical indicator color blocks. Main technical content: - GB/T 451.2 - Determination of the Quantity of Paper and Paperboard - GB/T 14233.2-2005 - Test Methods for Medical Infusion, Transfusion, and Syringe Equipment - GB 18282.1-2015 - Hygiene Requirements for Medical and Health Care Products Sterilization - WS/T 649 - Hygiene Requirements for Medical Low-temperature Steam Formaldehyde Sterilizers - YY/T 0681.2-2009 - Test Methods for Sterile Medical Device Packaging - Part 2: Sealing Strength of Flexible Barrier Materials - YY/T 0681.14-2018 - Test Methods for Sterile Medical Device Packaging - Part 14: Moisture and Dry Microbial Barrier Tests for Breathable Packaging Materials - YY/T 0698.3-2009 - Final Sterilization Medical Device Packaging Materials - Part 3: Requirements and Test Methods for Paper Used in the Production of Paper Bags, Composite Bags, and Roll Materials - YY/T 0698.5-2009 - Final Sterilization Medical Device Packaging Materials - Part 5: Requirements and Test Methods for Sealable Composite Bags and Roll Materials Composed of Breathable Materials and Plastic Films