Medical Device Packaging

Medical Device Packaging, Total:40 items.

The international standard classification for "Medical Device Packaging" includes: Sterilization and disinfection , sterilized packaging .

The Chinese standard classification for "Medical Device Packaging" includes: Medical apparatus and devices in general , Public medical equipment , General and microsurgical devices .

Group Standards of the People's Republic of China

T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices
T/CAMDI 009-2018 Sterile Medical Device Package - Part 1： Test Methods for Particulate Matter
T/SHBX 005-2023 Sterilizable packaging films for medical devices
T/CAMDI 058-2020 Packaging for terminally sterilized medical devices—Guidance on the application of GB/T 19633.1 and GB/T 19633.2
T/CAMDI 009.10-2020 Cleanliness of primary package for sterile medical device - Part 10：limits of contamination
T/CAMDI 015-2018 Good Manufacturing Practice for Primary Packaging of Sterile Medical Devices

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes
GB/T 19633.2-2015 Packaging for terminally sterilized medical devices―Part 2:Validation requirements for forming,sealing and assembly processes
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices―Part 1:Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633-2005 Packaging for terminally sterilized medical devices

Professional Standard - Medicine

YY/T 0681.9-2011 Test methods for sterile medical device package—Part 9:Burst testing of flexible package seals using internal air pressurization weight restraining plates
YY/T 0681.7-2011 Test methods for sterile medical device package—Part 7:Evaluating inks or coating adhesion to flexible packaging materials using tape
YY/T 0681.3-2010 Test methods for sterile medical device package—Part 3:Internal pressurization failure resistance of unrestrained packages
YY/T 0681.6-2011 Test methods for sterile medical device package—Part 6：Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials
YY/T 0681.5-2010 Test methods for sterile medical device package—Part 5:Detecting gross leaks in medical packaging by internal pressurization(bubble test)
YY/T 0681.1-2009 Test methods for sterile medical device package—Part 1:Test guide for accelerated aging
YY/T 0681.8-2011 Test methods for sterile medical device package—Part 8:Coating/adhesive weight determination
YY/T 0698.1-2011 Packaging materials for terminal sterilized medical devices—Part 1:Co-extrusion plastic films used for vacuum forming packaging—Requirements and test methods
YY/T 0681.10-2011 Test methods for sterile medical device package—Part 10:Test for microbial barrier ranking of porous package material
YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
YY/T 0698.4-2009 Packaging materials for terminal sterilized medical devices—Part 4:Paper bags—Requirements and test methods
YY/T 0681.4-2010 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration

国家药监局

YY/T 0681.15-2019 Test methods for sterile medical device package - Part 15: Performance testing of shipping containers and systems
YY/T 0681.1-2018 Test methods for sterile medical device package―Part 1:Test guide for accelerated aging
YY/T 0681.16-2019 Test methods for sterile medical device package—Part 16:Test for climatic stressing of packaging system

国家食品药品监督管理局

YY/T 0681.14-2018 Test methods for sterile medical device package—Part 14:Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air

Professional Standard - Commodity Inspection

SN/T 3061-2011 Rules of the Inspection of Packaging for Import Terminally Sterilized Medical Devices

German Institute for Standardization

DIN 96042:2006 Medical instruments - Packaging - Technical specification

American Society for Testing and Materials (ASTM)

ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F1980-99e1 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
ASTM F2475-20 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

American National Standards Institute （ANSI)

AAMI TIR22:1998 Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices, 1ed

SCC

AAMI 11607:1997 Packaging for terminally sterilized medical devices
AAMI/ISO 11607:2000 Packaging for terminally sterilized medical devices
NS-EN 868-2:2009 Packaging for terminally sterilized medical devices — Part 2: Sterilization wrap — Requirements and test methods

Korean Agency for Technology and Standards (KATS)

KS P ISO 11607-2007 Packaging for terminally sterilized medical devices

GSO

GSO ASTM F2475:2022 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
BH GSO ASTM F2475:2023 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials