Pyrogenicity - Principles and methods for pyrogen testing of medical devices
This document specifies the principles and methods for pyrogen testing of medical devices and their materials.
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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:
Part A — Terms and Conditions of Sale, which governs the purchase of the Product;
Part B — End Customer Licence Agreement, which governs the use of the Product;
Part C — Use of the Website and Account, which governs use of the Nimonik Online Store and applies to all users, whether or not a purchase is made; and
Part D — General Terms, which applies to Parts A, B, and C.
By placing an order for, or accessing, downloading, printing, installing, or otherwise using, a Product or the Nimonik Online Store, you accept and agree to be bound by these Terms.
The following definitions apply throughout this document, including Part A and Part B:
”Nimonik” means Document Center Inc., a California corporation, with its registered office at 401 Roland Way, Ste#224, Oakland, CA, 94621, United States.
”Nimonik Online Store” means Nimonik’s online standards store at https://standards.nimonik.com, through which Products are offered, ordered, accessed, and delivered.
”Licensee” or “you” means the purchaser or end-user of the Product.
”Product” means the standard, publication, document, or other content supplied by Nimonik, whether in electronic format or in hard-copy printed format. Any reference to the Product includes the Product in its entirety or any part thereof, as applicable.
”Owner” means the copyright holder of the Product identified on or within the Product.
”Licence Fee” means the amount paid by the Licensee for the Product.
”T&Cs” means the Terms and Conditions of Sale set out in Part A.
These T&Cs govern the purchase of Products by the Licensee from Nimonik.
By placing an order for a Product, or by accessing, downloading, installing, or otherwise using the Product, the Licensee accepts and agrees to be bound by these T&Cs and by the End Customer Licence Agreement set out in Part B. The Licensee shall ensure that it has read and understood all applicable terms before completing the purchase.
Any questions regarding these Terms may be addressed to Nimonik via https://standards-nimonik.freshdesk.com/support/tickets/new
The Licensee shall pay the applicable price for the Product. Once a card payment has been processed, an invoice confirming the payment will be emailed to the Licensee. Orders are paid by credit card and are charged in full at the time the order is placed.
Where invoice payment has been approved by Nimonik in writing, an invoice will be issued for payment in accordance with the following terms:
Payment is due in full within thirty (30) days of the invoice date, unless otherwise agreed in writing by Nimonik.
Payments must be made in U.S. Dollars (USD) and include the relevant order number.
Nimonik may accrue interest on overdue amounts at the rate of 1.5% per month, or the maximum rate permitted by applicable law, whichever is lower, calculated from the due date until paid in full. The Licensee shall be responsible for all reasonable costs of collection, including legal fees.
Nimonik may suspend or withhold delivery of, or access to, any Product until all overdue amounts have been paid in full.
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Nimonik uses reasonable efforts to ensure that prices and product information displayed on the Nimonik Online Store are accurate. However, errors may occur. Nimonik reserves the right to correct any errors, inaccuracies, or omissions, and to change or update prices and information at any time without prior notice. In the event a Product is listed at an incorrect price or with incorrect information due to a typographical or other error, Nimonik may, at its discretion, cancel or refuse any order placed for that Product, whether or not the order has been confirmed and payment processed. If payment has already been taken for a cancelled order, Nimonik will issue a full refund of the amount charged.
Products are made available only in one of two formats:
in electronic format, accessible for authenticated users via the Nimonik Online Store, as either a downloadable PDF or a view-only PDF (depending on the digital rights management (DRM) requirements applicable to the Product), or
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Products are made available/dispatched once the order has been processed.
Any delivery times, dispatch times, or shipping estimates shown in the Nimonik Online Store or at checkout are approximate and provided for guidance only. Actual delivery times may vary and depend on a range of factors, including order processing, payment clearance, product format, carrier performance, destination, customs handling, and other circumstances beyond Nimonik’s reasonable control. Nimonik does not guarantee any specific delivery or dispatch date and shall not be liable for any delay in delivery.
Returns are not accepted for electronic Products (PDF).
Returns of hard-copy Products may be accepted only in cases of duplicate orders or, on an exceptional basis, on a case-by-case assessment. In all instances, returns are subject to Nimonik’s prior agreement and must follow the procedure specified by Nimonik.
For termination of the use rights, please refer to the End Customer Licence Agreement in Part B.
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In the event of any inconsistency, the End Customer Licence Agreement shall prevail with respect to the use of Products.
TO THE MAXIMUM EXTENT PERMITTED BY LAW, THE PRODUCTS ARE PROVIDED “AS IS” AND “AS AVAILABLE,” AND ARE SOLD AND LICENSED WITHOUT ANY REPRESENTATION OR WARRANTY OF ANY KIND, WHETHER EXPRESS, IMPLIED, OR STATUTORY, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, ACCURACY, OR NON-INFRINGEMENT.
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NIMONIK’S TOTAL AGGREGATE LIABILITY ARISING OUT OF OR IN CONNECTION WITH THESE T&Cs OR ANY PRODUCT SHALL NOT EXCEED THE AMOUNT ACTUALLY PAID BY THE LICENSEE FOR THE PRODUCT GIVING RISE TO THE CLAIM. NOTHING IN THESE T&Cs EXCLUDES OR LIMITS LIABILITY THAT CANNOT BE EXCLUDED OR LIMITED UNDER APPLICABLE LAW, INCLUDING LIABILITY FOR DAMAGE CAUSED BY GROSS NEGLIGENCE OR INTENT.
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This agreement (the “Agreement”) sets out the terms on which the Licensee may use the Product. This Agreement is entered into together with, and forms part of the same overall agreement as, the T&Cs.
By placing an order for a Product, or by accessing, downloading, printing, installing, or otherwise using the Product, the Licensee accepts and agrees to be bound by this Agreement and the T&Cs. The Licensee shall ensure that it has read and understood all applicable terms before completing the purchase.
Any questions regarding this Agreement may be addressed to Nimonik via https://standards-nimonik.freshdesk.com/support/tickets/new
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All right, title, and interest in and to the Product, together with any updates, corrections, derivative works, or ancillary materials, and all intellectual property rights therein, are and shall remain with the Owner. Where a Product is supplied in physical form, ownership of that physical medium may transfer to the purchaser; however, all intellectual property rights in the content of the Product remain with the Owner. Nothing in this Agreement assigns, transfers, or grants the Licensee any intellectual property rights in the Product, except for the limited rights expressly set out herein.
If Nimonik or its licensors are no longer authorized to license a Product, or if a claim of infringement arises or in Nimonik’s opinion is likely to arise, Nimonik may withdraw access to the Product temporarily or permanently, and the Licensee shall promptly suspend or cease all use of such Product. Nimonik may also, in its sole discretion, discontinue or withdraw any Product.
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training, fine-tuning, or evaluating language models, machine-learning systems, generative AI models, or similar models or systems;
embedding, prompting, querying, comparing, or otherwise enabling an AI or ML model or system to ingest, reproduce, restate, summarize, translate, reformulate, or generate outputs derived from the Product;
structured extraction, text and data mining, harvesting, or processing of the text, structure, logic, metadata, or other elements of the Product for model training, dataset creation, benchmarking, or automated knowledge extraction; or
any other activity intended to enable an AI or ML system to ingest, analyze, internalize, or generate content based on the Product.
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(c) TO THE MAXIMUM EXTENT PERMITTED BY LAW, AND NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, THE TOTAL AGGREGATE LIABILITY OF NIMONIK AND THE OWNER ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ANY PRODUCT SHALL NOT EXCEED THE LICENCE FEE PAID BY THE LICENSEE FOR THE PRODUCT GIVING RISE TO THE CLAIM. NOTHING IN THIS AGREEMENT EXCLUDES OR LIMITS LIABILITY THAT CANNOT BE EXCLUDED OR LIMITED UNDER APPLICABLE LAW, INCLUDING LIABILITY FOR DAMAGE CAUSED BY GROSS NEGLIGENCE OR INTENT.
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You may not load, export, or re-export any of the Product, or any underlying information or technology, except in full compliance with all United States and other applicable laws and regulations.
BY ACCESSING, DOWNLOADING, PRINTING, OR OTHERWISE USING THE PRODUCT, YOU ACKNOWLEDGE THAT YOU HAVE READ THE TERMS OF THIS LICENCE AGREEMENT AND AGREE TO BE BOUND BY ITS TERMS.
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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Acceptable Use. You shall not use the Nimonik Online Store in any unlawful manner; attempt to gain unauthorized access to, interfere with, or disrupt the Nimonik Online Store or its underlying systems; introduce any malware or other harmful code; or use any robot, spider, scraper, or other automated means to access, harvest, index, or copy the Nimonik Online Store or its catalogue, except for standard search-engine indexing. You shall not resell, or provide commercial access to, the Nimonik Online Store. You shall not circumvent, disable, or interfere with any security, access control, or digital rights management (DRM) or other technical protection measure applied to the Nimonik Online Store or any Product.
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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.
Order of Precedence. Parts A, B, and C are to be read together as a single agreement. In the event of any inconsistency concerning the use of a Product, Part B prevails; in the event of any inconsistency concerning use of the Nimonik Online Store, Part C prevails.
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.
No Trademark Rights. Nothing in these Terms grants the Licensee any right to use Nimonik’s or the Owner’s trademarks, logos, or other brand identifiers. Any such use requires separate written authorization, and any unauthorized use constitutes a breach of these Terms.
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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.
Waiver. No failure or delay by Nimonik in exercising any right under these Terms shall operate as a waiver of that right, and no single or partial exercise of any right shall preclude any further exercise of that or any other right.
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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We will provide their services to you, which are subject to the conditions stated below in this document. Every time you visit this website, use its services or make a purchase, you accept the following conditions. This is why we urge you to read them carefully.
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