Section 444.00759 - Adoption of publications by reference; availability; review of editions and revisions by State Board of Health1. The following publications are hereby adopted by reference by the State Board of Health in the forms most recently published, unless the Board gives notice, in accordance with subsection 2, that the most recent edition or revision is not suitable for use in this State: (a) American National Standard ANSI/AAMI ST79, "Comprehensive guide to steam sterilization and sterility assurance in health care facilities," of the Association for the Advancement of Medical Instrumentation. A copy of the standard may be obtained from the Association for the Advancement of Medical Instrumentation at the Internet address http://my.aami.org/store for the price of $200 for members and $346 for nonmembers.(b) ASTM Standard F67, "Standard Specification for Unalloyed Titanium, for Surgical Implant Applications," of ASTM International. A copy of the standard may be obtained by mail from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, Pennsylvania 19428-2959, by telephone at (610) 832-9585 or at the Internet address http://www.astm.org, at a cost of $45.(c) ASTM Standard F136, "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications," of ASTM International. A copy of the standard may be obtained by mail from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, Pennsylvania 19428-2959, by telephone at (610) 832-9585 or at the Internet address http://www.astm.org, at a cost of $45.(d) ASTM Standard F138, "Standard Specification for Wrought 18Chromium-14Nickel-2.5M olybdenum Stainless Steel Bar and Wire for Surgical Implants," of ASTM International. A copy of the standard may be obtained by mail from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, Pennsylvania 19428-2959, by telephone at (610) 832-9585 or at the Internet address http://www.astm.org, at a cost of $45.(e) ASTM Standard F754, "Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube and Rod Shapes Fabricated from Granular Molding Powders," of ASTM International. A copy of the standard may be obtained by mail from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, Pennsylvania 19428-2959, by telephone at (610) 832-9585 or at the Internet address http://www.astm.org, at a cost of $40.(f) ISO 5832-1, "Implants for surgery - Metallic materials - Part 1: Wrought stainless steel," of the International Organization for Standardization. A copy of the standard may be obtained from the American National Standards Institute, 25 West 43rd Street, 4th Floor, New York, New York 10036, by telephone at (212) 642-4900 or at the Internet address http://www.webstore.ansi.org [File Link Not Available], at a price of $36 for members and $45 for nonmembers.(g) ISO 5832-3 "Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4-vanadium alloy," of the International Organization for Standardization. A copy of the standard may be obtained from the American National Standards Institute, 25 West 43rd Street, 4th Floor, New York, New York 10036, by telephone at (212) 642-4900 or at the Internet address http://www.webstore.ansi.org [File Link Not Available], at a price of $54.40 for members and $68.00 for nonmembers.(h) ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," of the International Organization for Standardization. A copy of the standard may be obtained from the American National Standards Institute, 25 West 43rd Street, 4th Floor, New York, New York 10036, by telephone at (212) 642-4900 or at the Internet address http://www.webstore.ansi.org [File Link Not Available], at a price of $148.(i) ISO 10993-6, "Biological evaluation of medical devices - Part 6: Tests for local effects after implantation," of the International Organization for Standardization. A copy of the standard may be obtained from the American National Standards Institute, 25 West 43rd Street, 4th Floor, New York, New York 10036, by telephone at (212) 642-4900 or at the Internet address http://www.webstore.ansi.org [File Link Not Available], at a price of $129.60 for members and $162.00 for nonmembers.(j) ISO 10993-10, "Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization," of the International Organization for Standardization. A copy of the standard may be obtained from the American National Standards Institute, 25 West 43rd Street, 4th Floor, New York, New York 10036, by telephone at (212) 642-4900 or at the Internet address http://www.webstore.ansi.org [File Link Not Available], at a price of $167.20 for members and $209.00 for nonmembers.(k)United States Pharmacopeia - National Formulary, published by the United States Pharmacopeial Convention. A copy of this publication may be obtained from the United States Pharmacopeial Convention, Customer Service Department, 7135 English Muffin Way, Frederick, Maryland 271704, or at the Internet address http://www.usp.org/store/products [File Link Not Available], for the price of $850.2. The State Board of Health will review each edition or revision of the publications adopted by reference pursuant to subsection 1 to ensure its suitability for the State. If the Board determines that an edition or revision is not suitable for this State, it will hold a public hearing to review its determination and give notice of that hearing within 6 months after the date on which the edition or revision was published, and give 30 days' notice of that hearing. If, after the hearing, the Board does not change its determination, the Board will give notice within 30 days after the hearing that the applicable addition or revision is not suitable for this State within 30 days after the hearing. If the Board does not give such notice, the edition or revision shall be deemed part of the publication adopted by reference pursuant to subsection 1.Nev. Admin. Code § 444.00759
Added to NAC by Bd. of Health by R112-16A, eff. 12/19/2017