The ISO 11607 standard aims to establish requirements and guidelines for the packaging of terminally sterilized medical devices. It ensures the safety, integrity, and sterility of medical devices throughout their lifecycle, from sterilization to final use.
ISO 11607-1
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems
ISO 11607-1 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems intended to maintain the sterility of terminally sterilized medical devices until the point of use.
ISO 11607-1 applies to the industry, healthcare facilities, and any location where medical devices are stored in sterile barrier systems and sterilized.
ISO 11607-1 does not cover all requirements for sterile barrier systems and packaging systems for aseptically manufactured medical devices. In such cases, additional requirements are necessary to ensure drug/device combinations.
ISO 11607-1 does not describe a quality assurance system for controlling all manufacturing stages.
ISO 11607-2
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing, and assembly processes
ISO 11607-2 specifies the requirements for the development and validation of packaging processes for terminally sterilized medical devices. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems, and packaging systems.
ISO 11607-2 applies to the industry, healthcare facilities, and any location where medical devices are packaged and sterilized.
ISO 11607-2 does not cover all requirements for aseptically manufactured medical devices. Additional requirements are needed to ensure drug/device combinations.
Standards referenced in ISO 11607:
ASTM F1980: Standard guide for accelerated aging of sterile medical device packages
EN 868-8: Materials and systems for packaging of sterilized medical devices - Part 8: Reusable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
ISO 536: Paper and board - Determination of grammage
ISO 187: Paper, board, and pulps - Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
ASTM D4332: Standard practice conditioning containers, packages or packaging components for testing
ISO 2233: Packaging - Complete, filled transport packages and unit loads - Conditioning for testing
ASTM F2096: Standard test method for detecting gross leaks in porous medical packaging by internal pressurization (Bubble test)
EN 868-5: Materials and systems for packaging of sterilized medical devices - Part 5: Sealable pouches and reels of paper and plastic film construction - Requirements and test methods
ASTM D4169: Standard practice for performance testing of shipping containers and systems
ISTA (International Safe Transit Association) Test Procedures
ISO 4180: Complete filled transport packages - General rules for establishing programs of test for qualification purposes - Part 1: General principles
EN 868-8: Materials and systems for packaging of sterilized medical devices - Part 8: Reusable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
ASTM F2338: Standard test method for nondestructive detection of leaks in packages by vacuum decay
ASTM F88: Standard test method for seal strength of flexible barrier materials
ASTM F1140: Standard test methods for failure resistance of unrestrained and nonrigid packages for medical applications
ASTM F2054: Standard test method for burst testing of flexible package seals using internal air pressurization within restraining plates
EN 868-5: Materials and systems for packaging of sterilized medical devices - Part 5: Sealable pouches and reels of paper and plastic film construction - Requirements and test methods
ASTM D3078: Standard test method for determination of leaks in flexible packaging by bubble emission.La norme ISO 11607 a pour but d'établir des exigences et des lignes directrices pour l'emballage des dispositifs médicaux stérilisés de façon terminale. Elle sert à garantir la sécurité, l'intégrité et la stérilité des dispositifs médicaux tout au long de leur cycle de vie, depuis leur stérilisation jusqu'à leur utilisation finale.