Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es).
The needle-based injection system containing electronics can be single use or reusable and can be operated with or without electrical/conductive connections to other devices. The system is intended to deliver medication to a patient by self-administration or by administration by one other operator (e.g. caregiver or health care provider).
This document applies to electronic accessories that are intended to be physically connected to a NIS or NIS-E according to the NIS/NIS-E intended use.
This document also applies to electronic accessories that are intended to have electrical/conductive connections to a NIS or NIS-E according to the NIS/NIS-E intended use.
This document does not specify requirements for software in programmable NIS-E.
NOTE IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 14 addresses software life cycle processes.
This document does not specify requirements for cybersecurity.
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Version 1 - 2026-06-22
These Terms and Conditions (the “Terms”) consist of four parts that together form a single, integrated agreement governing access to the Nimonik Online Store and the purchase and use of Products from Nimonik:
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This section applies to everyone who accesses or uses the Nimonik Online Store, whether or not a purchase is made. In this section, “you” means any such user.
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Website Availability. The Nimonik Online Store is provided on an “as is” and “as available” basis. Nimonik does not warrant that it will be uninterrupted, error-free, or secure, and may modify, suspend, or discontinue all or part of it at any time without notice. The disclaimers and limitations of liability in Part A, Section 7 apply equally to your access to and use of the Nimonik Online Store.
This Part D applies to Parts A, B, and C and to all access to and use of the Nimonik Online Store and the Products.
Governing Law and Dispute Resolution. These Terms are governed exclusively by the laws of the State of California, United States, without reference to its conflict of laws principles and to the exclusion of the United Nations Convention on Contracts for the International Sale of Goods. The parties consent to the exclusive jurisdiction of the state and federal courts located in California, United States. In any action to enforce these Terms, the prevailing party shall be entitled to recover its reasonable attorneys’ fees and costs.
Changes to these Terms. Nimonik may amend or update these Terms at any time by posting the revised Terms in the Nimonik Online Store. The version of these Terms in effect at the time an order is placed governs that order, and the version in effect at the time the Nimonik Online Store is used governs that use. Continued use of the Nimonik Online Store or any Product following any change constitutes acceptance of the revised Terms.
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Customer Terms Excluded. Any terms and conditions proposed by the Licensee, whether referenced in an order or contained in any other document, are expressly excluded and shall have no effect.
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Force Majeure. Nimonik shall not be liable for any failure or delay in performance resulting from causes beyond its reasonable control, including acts of God, natural disasters, labor disputes, carrier delays, failures of telecommunications or internet services, governmental action, or other events of force majeure.
Assignment. The Licensee may not assign or transfer these Terms, or any rights or obligations under them, without Nimonik’s prior written consent. Nimonik may freely assign these Terms. These Terms are binding upon and inure to the benefit of the parties and their permitted successors and assigns.
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Severability. If any provision of these Terms is held to be invalid, illegal, or unenforceable, it shall be limited or reformed only to the minimum extent necessary to make it enforceable, and the remaining provisions shall remain in full force and effect.
Entire Agreement. These Terms (Parts A, B, C, and D), together with the applicable order confirmation, constitute the entire agreement between Nimonik and the Licensee with respect to the Nimonik Online Store and the Products, and supersede all prior or contemporaneous understandings or agreements, whether written or oral. Headings are for convenience only and do not affect interpretation.
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