The series of standards NF EN 868 establishes requirements for materials and packaging systems used for sterilizable medical devices. These standards focus on various aspects of packaging, ranging from general requirements (NF EN 868-1) to more specific elements such as paper used in the manufacture of bags and pouches (NF EN 868-3), the paper bags themselves (NF EN 868-4), reusable containers (NF EN 868-8), and even non-woven polyolefin-based materials (NF EN 868-9 and 868-10).
Each standard details the testing methods and performance criteria necessary to ensure that the materials and packaging systems effectively maintain the sterility of the medical devices until their use.
NF EN 868-1: Packaging materials for medical devices - Requirements and tests
Standard Title: NF EN 868-1: Materials and packaging systems for medical devices to be sterilized - Part 1: General requirements and test methods.
Cancelled in 2007. This European standard specifies the requirements and test methods for materials and packaging systems:
- Used to package terminally sterilized medical devices; and
- Intended to maintain the sterility of the medical device.
NF EN 868-2: Medical device packaging - Sterilization wrap & tests
Standard Title: NF EN 868-2: Materials and packaging systems for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods.
This part of EN 868 provides test methods and applicable values for materials used in sterile barrier systems and/or packaging systems intended to maintain the sterility of terminally sterilized medical devices until their use. This part of EN 868 presents only the specific performance requirements and test methods of the products covered by this part of EN 868 but it does not add or modify the general requirements specified in EN ISO 11607-1. Consequently, the specific requirements indicated in paragraph 4.2 can be used to demonstrate compliance with one or more, but not all, of the requirements of EN ISO 11607-1. The materials specified in 4.2.2.1 to 4.2.2.3 of this part of EN 868 are intended for single-use; the materials specified in 4.2.2.4 are intended for reuse.
NF EN 868-3: Medical device packaging - Paper bags & pouches & tests
Standard Title: NF EN 868-3: Materials and packaging systems for terminally sterilized medical devices - Part 3: Paper used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods.
This part of EN 868 provides test methods and values for paper used in the manufacture of paper bags (specified in EN 868-4) and pouches and reels (specified in EN 868-5) used as sterile barrier systems and/or packaging systems intended to maintain the sterility of terminally sterilized medical devices until their use. This part of EN 868 presents only the specific performance requirements and test methods of the products covered by this part of EN 868 but it does not add or modify the general requirements specified in EN ISO 11607-1. Consequently, the specific requirements indicated in paragraph 4.2 can be used to demonstrate compliance with one or more, but not all, of the requirements of EN ISO 11607-1. The materials specified in this part of EN 868 are intended for single-use only.
NF EN 868-4: Medical packaging - Paper bags & Requirements and tests
Standard Title: NF EN 868-4: Materials and packaging systems for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods.
This part of EN 868 presents test methods and values for paper bags made from the paper specified in Part 3 of EN 868, and used as sterile barrier systems and/or packaging systems intended to maintain the sterility of terminally sterilized medical devices until their use. This part of EN 868 presents only the specific performance requirements and test methods of the products covered by this part of EN 868 but it does not add or modify the general requirements specified in EN ISO 11607-1. Consequently, the specific requirements in paragraphs 4.2 to 4.6 can be used to demonstrate compliance with one or more, but not all, of the requirements of EN ISO 11607-1. The materials specified in this part of EN 868 are intended for single-use only.
NF EN 868-5: Medical packaging - Heat-sealable pouches & tests
Standard Title: NF EN 868-5: Materials and packaging systems for terminally sterilized medical devices - Part 5: Heat-sealable pouches and reels composed of porous materials and plastic film - Requirements and test methods.
This part of EN 868 provides test methods and values for self-sealable and heat-sealable pouches and reels made from materials specified in EN 868, Part 2, 3, 6, 7, 9, or 10, and plastic film, used as sterile barrier systems and/or packaging systems intended to maintain the sterility of terminally sterilized medical devices until their use. This part of EN 868 presents only the specific performance requirements and test methods of the products covered by this part of EN 868 but it does not add or modify the general requirements specified in EN ISO 11607-1. Consequently, the specific requirements in paragraphs 4.2 to 4.5 can be used to demonstrate compliance with one or more, but not all, of the requirements of EN ISO 11607-1. The materials specified in this part of EN 868 are intended for single-use only.
NF EN 868-6: Medical packaging - Paper, low-temperature sterilization & tests
Standard Title : NF EN 868-6: Materials and packaging systems for terminally sterilized medical devices - Part 6: Paper for low-temperature sterilization processes - Requirements and test methods.
This part of EN 868 provides test methods and values for paper used in the manufacture of preformed sterile barrier systems and/or packaging systems intended to maintain the sterility of terminally sterilized medical devices until their use. This part of EN 868 presents only the specific performance requirements and test methods of the products covered by this part of EN 868 but it does not add or modify the general requirements specified in EN ISO 11607-1. Consequently, the specific requirements in paragraphs 4.2 to 4.3 can be used to demonstrate compliance with one or more, but not all, of the requirements of EN ISO 11607-1. The paper specified in this part of the EN 868 series is intended for use in the partial or complete manufacture of pouches, thermoformed packaging, and lids for packaging. The materials specified in this part of EN 868 are intended for single-use only.
NF EN 868-7: Medical packaging - Adhesive paper, low-temperature sterilization & tests
Standard Title: NF EN 868-7: Materials and packaging systems for terminally sterilized medical devices - Part 7: Adhesive-coated paper for low-temperature sterilization processes - Requirements and test methods.
This part of EN 868 provides test methods and values for adhesive-coated sealing paper made from paper that complies with the requirements of EN 868-6 and used as heat-sealable sterile barrier systems and/or packaging systems intended to maintain the sterility of terminally sterilized medical devices until their use. The materials described in this part are intended for use with ethylene oxide or irradiation sterilization. This part of EN 868 presents only the specific performance requirements and test methods of the products covered by this part of EN 868 but it does not add or modify the general requirements specified in EN ISO 11607-1. Consequently, the specific requirements in paragraphs 4.2 to 4.3 can be used to demonstrate compliance with one or more, but not all, of the requirements of EN ISO 11607-1. The materials specified in this part of EN 868 are intended for single-use only.
NF EN 868-8: Medical packaging - Containers for steam sterilization & tests
Standard Title: NF EN 868-8: Materials and packaging systems for terminally sterilized medical devices - Part 8: Reusable sterilization containers for steam sterilizers complying with EN 285 - Requirements and test methods.
This part of EN 868 presents test methods and values for reusable containers used as preformed sterile barrier systems intended to maintain the sterility of terminally sterilized medical devices until their use. These containers are intended for use in steam sterilizers complying with EN 285. This part of EN 868 presents only the specific performance requirements and test methods of the products covered by this part of EN 868 but it does not add or modify the general requirements specified in EN ISO 11607-1. Consequently, the specific requirements in paragraphs 4.2 to 4.5 can be used to demonstrate compliance with one or more, but not all, of the requirements of EN ISO 11607-1.
NF EN 868-9: Medical packaging - Polyolefin nonwovens & tests
Standard Title: NF EN 868-9: Materials and packaging systems for terminally sterilized medical devices - Part 9: Polyolefin-based nonwoven materials, non-coated - Requirements and test methods.
This part of EN 868 provides test methods and values for uncoated non-woven polyolefin-based materials used in preformed sterile barrier systems and/or packaging systems intended to maintain the sterility of terminally sterilized medical devices until their use. This part of EN 868 presents only the specific performance requirements and test methods of the products covered by this part of EN 868 but it does not add or modify the general requirements specified in EN ISO 11607-1. Consequently, the specific requirements in paragraphs 4.2 to 4.3 can be used to demonstrate compliance with one or more, but not all, of the requirements of EN ISO 11607-1. The materials specified in this part of EN 868 are intended for single-use only.
NF EN 868-10: Medical packaging - Adhesive polyolefin nonwovens & tests
Standard Title: NF EN 868-10: Materials and packaging systems for terminally sterilized medical devices - Part 10: Adhesive-coated polyolefin-based nonwoven materials - Requirements and test methods.
This part of EN 868 provides test methods and values for adhesive-coated non-woven polyolefin-based materials manufactured from non-woven materials in accordance with EN 868-9 and used as sterile barrier systems and/or packaging systems intended to maintain the sterility of terminally sterilized medical devices until their use. This part of EN 868 presents only the specific performance requirements and test methods of the products covered by this part of EN 868 but it does not add or modify the general requirements specified in EN ISO 11607-1. Consequently, the specific requirements in paragraphs 4.2 to 4.3 can be used to demonstrate compliance with one or more, but not all, of the requirements of EN ISO 11607-1. The materials specified in this part of EN 868 are intended for single-use only.