Numeral 20 — NOM-241-SSA1-2025, Buenas prácticas de fabricación de dispositivos médicos

20 Bibliografía

20.1 Farmacopea de los Estados Unidos Mexicanos 13.0. México (2021).

20.2 Suplemento para dispositivos médicos de la Farmacopea de los Estados Unidos Mexicanos 5.0. México (2023).

20.3 ISO 11135-1:2014. Sterilization of health care products-Ethylene oxide-Part 1: Requirements for development, validation

and routine control of sterilization process for medical devices.

20.4 ISO/TS 11135-2:2014 Sterilization of health care products-Ethylene oxide-Part 2: Guidance on the application of ISO

11135-1.

20.5 ISO 11137-1:2013. Sterilization of health care products--Radiation-Part 1: Requirements for validation and routine control

of a sterilization process for medical.

20.6 ISO 11137-2:2006 Sterilization of health care products-Radiation-Part 2: Establishing the sterilization dose.

20.7 ISO 11137-3:2006 Sterilization of health care products-Radiation-Part 3: Guidance on dosimetric aspects.

20.8 ISO 19011:2011. Guidelines for quality and /or environmental management systems auditing.

20.9 ISO 14644-1:2015. Cleanrooms and associated controlled environments--Part 1: Classification of air cleanliness.

20.10 ISO 14644-2:2015. Cleanrooms and associated controlled environments--Part 2: Specifications for testing and

monitoring to prove continued compliance with ISO 14644-1.

20.11 ISO 14644-3:2005. Cleanrooms and associated controlled environments--Part 3: Test methods.

20.12 ISO 14644-4:2001. Cleanrooms and associated controlled environments--Part 4: Design, construction and start-up.

20.13 ISO 14644-5:2004. Cleanrooms and associated controlled environments--Part 5: Operations.

20.14 ISO 14971:2007. Medical devices--Application of risk management to medical devices.

20.15 ISO 4074:2015. Natural rubber latex male condoms - Requirements and test methods.

20.16 ANSI/ASQC 01-1988. Generic guidelines for auditing of quality systems.

20.17 ASTM F 1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

20.18 Code of Federal Regulations Title 21; Part 820, Medical Device Good Manufacturing Practices Manual.- Washington,

Food and Drug Administration, 2001.

https://www.dof.gob.mx/nota_detalle.php?codigo=5754074&fecha=04/04/2025&print=true 54/57

20.19 Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing Practice.-

Washington, Food and Drug Administration, september 2004.

20.20 Final Version of Annex 15 to the EU Guide to Good Manufacturing Practice; European Commission, Brussels, 2015.

20.21 European Commission, Guide to Good Manufacturing Practice Annex I.

20.22 European Commission, Guide to Good Manufacturing Practice Annex 1, Manufacture of Sterile Medicinal Products, June

2008.

20.23 European Commission, Guide to Good Manufacturing Practice Annex 15, Qualification and validation, July 2001.

20.24 Manufacture of Sterile Medicinal Products, January 1997.

20.25 Points to Consider for Aseptic Processing, PDA Journal of Pharmaceutical Science and Technology, 2015, Part 1. Points

to Consider for Aseptic Processing, PDA Journal of Pharmaceutical Science and Technology, 2016, Part 2.

20.26 U.S. Foods and Drug Administration. Guidance for Industry Process Validation: General Principles and Practices.

Washington, January 2011.

20.27 European Medicines Agency, Guideline on process validation for finished products-information and data to be provided in

regulatory submissions, United Kingdom, 27 February 2014.

20.28 ISPE. GAMP

5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition), 2022.

20.29 IMDRF/SaMD WG/N10FINAL:2013. Software as a Medical Device (SaMD): Key Definitions. December 2013.

20.30 IMDRF/SaMD WG/N12FINAL:2014. Software as a Medical Device (SaMD): Possible Framework for Risk Categorization

and Corresponding Considerations. September 2014.

20.31 IMDRF/SaMD WG/N41FINAL:2017. Software as a Medical Device (SaMD): Clinical Evaluation. June 2017.

20.32 Guidance for Industry and Food and Drug Administration Staff. Mobile Medical Applications: Guidance for Food and Drug

Administration Staff. February 2015.

20.33 IMDRF/GRRP WG N52 FINAL:2024 "Principios de Etiquetado de los Dispositivos Médicos y los Dispositivos Médicos de

Diagnóstico In Vitro.'" Washington, D.C.: OPS, -1, 2022