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Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integ…

Overview EN ISO 11608-3:2022/A1:2026 specifies updated requirements and test methods for containers and integrated fluid paths in needle-based injection systems (NIS) for medical use. Issued by CEN a…

Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions…

Overview EN ISO 11608-5:2023 - Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022) defines safety, performance and test-met…

Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions…

Overview EN ISO 11608-5:2023 - Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022) defines safety, performance and test-met…

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integ…

Overview EN ISO 11608-3:2022 (Corrected version 2023-01) is the CEN-endorsed part of the ISO 11608 series that specifies requirements and test methods for design verification of containers and integr…

Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injecti…

Overview EN ISO 11608-4:2022 (Corrected version 2024-12) specifies requirements and test methods for needle-based injection systems containing electronics (NIS-E). It covers electronic needle-based i…

Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen nee…

Overview EN ISO 11608-2:2022 - "Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles" is the CEN-adopted European version of ISO 11608-2:2…

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injecti…

Overview EN ISO 11608-1:2022 - Needle-based injection systems for medical use - Part 1: Needle-based injection systems (ISO 11608-1:2022) specifies requirements and test methods for needle-based inje…

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injecti…

Overview EN ISO 11608-1:2022 - Needle-based injection systems for medical use - Part 1: Needle-based injection systems (ISO 11608-1:2022) specifies requirements and test methods for needle-based inje…

Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen nee…

Overview EN ISO 11608-2:2022 - "Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles" is the CEN-adopted European version of ISO 11608-2:2…

Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injecti…

Overview EN ISO 11608-4:2022 (Corrected version 2024-12) specifies requirements and test methods for needle-based injection systems containing electronics (NIS-E). It covers electronic needle-based i…

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integ…

Overview EN ISO 11608-3:2022 (Corrected version 2023-01) is the CEN-endorsed part of the ISO 11608 series that specifies requirements and test methods for design verification of containers and integr…

Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for pe…

Overview EN ISO 11608-7:2017 (ISO 11608-7:2016) specifies accessibility requirements and test methods for needle-based injection systems (NIS) intended for self-administration or caregiver use by peo…

Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for pe…

Overview EN ISO 11608-7:2017 (ISO 11608-7:2016) specifies accessibility requirements and test methods for needle-based injection systems (NIS) intended for self-administration or caregiver use by peo…

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injecti…

Pen-injectors for medical use — Part 1: Pen-injectors — Requirements and test methods

Pen-injectors for medical use — Part 3: Finished cartridges — Requirements and test methods

Pen-injectors for medical use — Part 2: Needles — Requirements and test methods

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injecti…

Overview ISO 11608-1:2022/Amd 1:2026 is the first amendment to ISO 11608-1:2022, focusing on needle-based injection systems (NIS) for medical use. Developed by the International Organization for Stan…

Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integ…

Overview ISO 11608-3:2022/Amd 1:2026 is an international standard amendment focused on needle-based injection systems (NIS) for medical use, specifically addressing requirements and test methods for…

Needle-based injection systems for medical use. Requirements and test methods - Needles

1 Scope This part of ISO 11608 specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems ( NISs ) that fulfil the specifications of ISO…

Needle-based injection systems for medical use. Requirements and test methods - Automated functions

1 Scope This part of ISO 11608 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions ( NIS-AUTO ), for the administration of m…

Needle-based injection systems for medical use. Requirements and test methods - Finished containers

1 Scope This part of ISO 11608 specifies the functional and design considerations for containers to be used with needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1. It…

Pen-injectors for medical use - Requirements and test methods for electronic and electromechanical pen-inject…

1 Scope This part of ISO 11608 specifies requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges. Th…

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injecti…

Overview SIST EN ISO 11608-1:2022/A1:2026 is an international amendment standard specifying requirements and test methods for needle-based injection systems (NIS) used in medical settings. This amend…

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integ…

Overview SIST EN ISO 11608-3:2022/A1:2026 is an internationally harmonized amendment to ISO 11608-3, which specifies the requirements and test methods for containers and integrated fluid paths in nee…

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injecti…

Overview EN ISO 11608-1:2022/A1:2026 is the latest amendment to the standard for needle-based injection systems (NIS) for medical use, specifically focusing on part 1: requirements and test methods.…

Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integ…

Overview ISO 11608-3:2022 - Needle-based injection systems for medical use - Part 3: Containers and integrated fluid paths - specifies requirements and test methods for design verification of contain…

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injecti…

Overview ISO 11608-1:2022 - Needle-based injection systems for medical use (Part 1) specifies requirements and test methods for needle-based injection systems (NISs) designed for single-patient, bolu…

Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-ended pen nee…

Overview ISO 11608-2:2022 specifies requirements and test methods for single-use, sterile double-ended pen needles used with needle-based injection systems (NISs), such as pen injectors. Part 2 of th…

Pen-injectors for medical use — Part 4: Requirements and test methods for electronic and electromechanical pe…

Needle-based injection systems for medical use. Requirements and test methods. Needle-based injection systems.

Tracked Changes. Needle-based injection systems for medical use. Requirements and test methods. Double-ended…

Needle-based injection systems for medical use. Requirements and test methods. Containers and integrated flui…

Tracked Changes. Needle-based injection systems for medical use. Requirements and test methods. Automated fun…

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injecti…

Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions

Needle-based injection systems for medical use — Requirements and test methods — Part 2: Needles

Needle-based injection systems for medical use — Requirements and test methods — Part 3: Finished containers

Needle-based injection systems for medical use. Requirements and test methods. Needle-based injection systems…

Needle-based injection systems for medical use. Requirements and test methods. Accessibility for persons with…

Needle-based injection systems for medical use. Requirements and test methods. On-body delivery systems.

Needle-based injection systems for medical use. Requirements and test methods. Automated functions.

Needle-based injection systems for medical use. Requirements and test methods. Double-ended pen needles. Part…

Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery sys…

Overview ISO 11608-6:2022 - "Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery systems" defines safety and performance requirements and test me…

Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions

Overview ISO 11608-5:2022 - "Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions" defines requirements and test methods for automated function…

Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injecti…

Overview ISO 11608-4:2022 specifies requirements and test methods for needle-based injection systems containing electronics (NIS‑E). It covers single‑use and reusable NIS‑Es, with or without software…

Needle-based injection systems for medical use — Requirements and test methods — Part 7: Accessibility for pe…

Overview ISO 11608-7:2016 - "Needle-based injection systems for medical use - Part 7: Accessibility for persons with visual impairment" - specifies requirements and test methods to make needle-based…