Sterile instrument packaging

Sterile instrument packaging, Total:35 items.

The international standard classification for "Sterile instrument packaging" includes: Disinfectants and antiseptics .

The Chinese standard classification for "Sterile instrument packaging" includes: General and microsurgical devices .

---

Group Standards of the People's Republic of China

• T/CAMDI 009-2018 Sterile Medical Device Package - Part 1： Test Methods for Particulate Matter
• T/CAMDI 009.2-2020 Cleanliness of Primary Packaging of Sterile Medical Devices Part 2: Particle Contamination Test Method Liquid Elution Method
• T/CAMDI 009.10-2023 Cleanliness of primary package for sterile medical device - Part 10：Limits of contamination
• T/CAMDI 009.10-2020 Cleanliness of primary package for sterile medical device - Part 10：limits of contamination
• T/CAMDI 009.10-2024 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

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 0681.12-2022 Test methods for sterile medical device package―Part 12:Flex durability of flexible barrier materials
• YY/T 0681.11-2014 Test methods for sterile medical device package―Part 11:Determining integrity of seals for medical packaging by visual inspection
• 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 0681.12-2014 Test methods for sterile medical device package―Part 12:Flex durability of flexible barrier films
• YY/T 0681.3-2010 Test methods for sterile medical device package—Part 3:Internal pressurization failure resistance of unrestrained packages
• YY/T 0681.8-2011 Test methods for sterile medical device package—Part 8:Coating/adhesive weight determination
• 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 0681.6-2011 Test methods for sterile medical device package—Part 6：Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials
• YY/T 0681.4-2010 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration
• YY/T 0681.1-2009 Test methods for sterile medical device package—Part 1:Test guide for accelerated aging
• 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 0681.2-2010 Test methods for sterile medical device package—Part 2:Seal strength of flexible battier materials

国家药监局

• YY/T 0681.4-2021 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration
• 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 0681.18-2020 Test methods for sterile medical device package—Part 18:Nondestructive detection of leaks in packages by vacuum decay method
• YY/T 0681.16-2019 Test methods for sterile medical device package—Part 16:Test for climatic stressing of packaging system
• YY/T 0681.17-2019 Test methods for sterile medical device package - Part 17: Testing the microbial barrier performance of porpous package materials using aerosol filtration method

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

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

International Organization for Standardization (ISO)

• ISO/TS 16775:2021 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
• ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
• ISO 11607-1:2006/Amd 1:2014 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems; Amendment 1
• ISO/DIS 23417:1975 General specifications and validation methods for non-sterile medical device packages in good distribution practice principles

British Standards Institution (BSI)

• BS PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2

Association Francaise de Normalisation

• NF S98-052-1/A1:2014 Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems - Amendment 1

Others: Sterile Packaging Validation,Package Integrity Sterile,Aseptic packaging,Aseptic packaging confirmation,Three aseptic packaging,Sterile medical device packaging,Sterilization Confirmation of Sterile Medical Devices,Standard Aseptic Packaging,Medical Device Packaging Materials,Test Methods for Sterile Medical Device Packaging Part 18,Medical Device Packaging Materials,Sterile medical device packaging,Medical Device Packaging Regulations,Medical Device Packaging Regulations,Medical Device Packaging,Medical Device Packaging,Class I device packaging,Non-sterile product medical devices,Sterile Medical Devices,Test method for sterile medical device packaging part 1