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Guidelines for the development and use of medical electrical equipment educational materials
Guidelines for the development and use of medical electrical equipment educational materials
IEC/TR 61258:2008(E), which is a technical report, outlines a generic process for developing materials for education and training of operators of medical electrical equipment or a medical electrical system, hereafter referred to collectively as equipment.
It can be used by standards organizations, manufacturers, health care facility managers, clinical engineers, physician and nurse educators, and others involved directly or indirectly in education and training of operators.
In particular, manufacturers might find this process useful in preparing the necessary markings, accompanying documents and other educational materials which will provide necessary information to operators of the equipment and encourage them to employ safe and effective practices.
This technical report is not intended to be used for regulatory purposes.
This second edition cancels and replaces the first edition published in 1994. This edition constitutes a technical revision.
This edition has been aligned with IEC 60601-1:2005 to include medical electrical systems within its scope. Usability engineering concepts from IEC 62366:2007 have also been added to this edition.
| SDO | IEC: International Electrotechnical Commission |
| Document Number | IEC/TR 61258 |
| Publication Date | Aug. 1, 2008 |
| Language | en - English |
| Page Count | |
| Revision Level | 2.0 |
| Supercedes | |
| Committee | 62A |
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Version 1 - 2026-06-22
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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
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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.
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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.
Account. You must provide accurate and complete information when registering for an account and keep it up to date. You are responsible for keeping your account credentials confidential and for all activity that occurs under your account. Accounts are personal to a single user and may not be shared. You must notify Nimonik promptly of any unauthorized use of your account. Nimonik may suspend or terminate an account at any time for breach of these Terms or suspected misuse.
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.
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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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