Packaging for Terminally Sterilized Medical Devices

Packaging for Terminally Sterilized Medical Devices, Total:29 items.

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

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

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

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

Group Standards of the People's Republic of China

• T/CAMDI 058-2020 Packaging for terminally sterilized medical devices—Guidance on the application of GB/T 19633.1 and GB/T 19633.2

Professional Standard - Medicine

• YY/T 0698.8-2009 Packaging materials for terminally sterilized medical devices—Part 8:Re-usable sterilization containers for steam sterilizers—Requirements and test methods
• 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 0698.4-2009 Packaging materials for terminal sterilized medical devices—Part 4:Paper bags—Requirements and test methods

未注明发布机构

• CAN/CSA-ISO/TS 16775:2017 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2

国家药监局

• YY/T 0698.2-2022 Packaging materials for final sterilized medical devices-Part 2: Requirements and test methods for sterilized packaging materials

American National Standards Institute （ANSI)

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

Korean Agency for Technology and Standards (KATS)

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

SCC

• AAMI 11607:1997 Packaging for terminally sterilized medical devices
• NS-EN 868-2:2017 Packaging for terminally sterilized medical devices — Part 2: Sterilization wrap — Requirements and test methods
• UNE-EN 868-2:2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
• CSA ISO/TS 16775:2023 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
• NS-EN 868-4:2017 Packaging for terminally sterilized medical devices — Part 4: Paper bags — Requirements and test methods
• BS EN ISO 11607-2:2006+A1:2014 Packaging for terminally sterilized medical devices-Validation requirements for forming, sealing and assembly processes
• DIN EN 868-2 E:2015 Draft Document - Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German and English version prEN 868-2:2015

German Institute for Standardization

• DIN EN 868-2:2017-05 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German version EN 868-2:2017
• DIN EN 868-4:2017-05 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German version EN 868-4:2017

Association Francaise de Normalisation

• NF EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: sterilization envelope - Requirements and test methods
• NF EN 868-4:2017 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 4 : sacs en papier - Exigences et méthodes d'essai

GSO

• OS GSO ISO/TS 16775:2015 Packaging for terminally sterilized medical devices -- Guidance on the application of ISO 11607-1 and ISO 11607-2

Lithuanian Standards Office

• LST EN 868-4-2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

Danish Standards Foundation

• DS/EN 868-4:2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

AENOR

• UNE-EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

British Standards Institution (BSI)

• 24/30479649 DC BS EN 868-2 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods

Others: Microbial barrier test of packaging materials for medical devices to be sterilized,Microbial barrier test of packaging materials for sterilized medical devices,Packaging for Terminally Sterilized Medical Devices,Final Medical Device Packaging Materials,Packaging of terminally sterilized medical devices,Terminally Sterilized Medical Devices