Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
This document provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, i.e. physico‑chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device's intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness.
This document does neither address the identification or quantification of degradation products nor the evaluation of the physico-chemical properties of the degraded materials, which are covered in ISO 10993‑9, ISO 10993‑13, ISO 10993‑14 and ISO 10993‑15.
Chemical characterization of materials is covered by ISO 10993‑18.
The ISO 10993 series is not applicable when the material or device is not in contact with the body directly or indirectly.
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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:
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(b) If an allegation of infringement of third-party rights is made, or in Nimonik’s or the Owner’s opinion is likely to be made, with respect to any Product, Nimonik may, at its option and expense, (i) obtain for you the right to continue using the Product, (ii) modify or replace the Product so as to avoid the claim, or (iii) refund the Licence Fee. Nimonik shall have no liability if any claim would have been avoided except for your refusal to use a modified or replacement Product or to cease using the Product. This Section 9(b) states the entire liability of Nimonik and the Owner with respect to any infringement or alleged infringement of third-party rights.
(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.
This licence is granted only for the edition of the Product confirmed in Nimonik’s order confirmation and does not grant any rights to revisions or new editions of the Product. This Agreement may be terminated immediately by the Owner or Nimonik upon breach of any provision by you. Upon any expiration or termination of this Agreement, you shall immediately discontinue all use of the Product and shall, within ten (10) days, either return any hard-copy Product to Nimonik or certify in writing to Nimonik that all electronic copies of the Product (including any printed copy and any backup copy) have been permanently deleted from your devices and eliminated from your premises. Provisions that by their nature are intended to survive termination shall so survive.
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.
Website Intellectual Property. The Nimonik Online Store, including its design, layout, text, graphics, logos, and trademarks is owned by Nimonik or its licensors and is protected by applicable laws. Accessing the Nimonik Online Store grants you no rights in it other than the limited right to access and use it to browse and purchase Products. Use of the Products themselves is governed by Part B.
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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Content published on this website (digital downloads, images, texts, graphics, logos) is the property of Nimonik and/or its respective licensors and protected by international copyright laws. The entire compilation of the content found on this website is the exclusive property of Nimonik and its respective licensors, with copyright authorship for this compilation by Nimonik and its respective licensors.
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