BME 180A - Biomedical Design - Fall 2023

Remember, Technical Standards are an established norm or requirement. It is usually a formal document that establishes uniform engineering or technical criteria, methods, processes and practices. The documents prepared by a professional group or committee which are believed to be good and proper engineering practices and which contain mandatory requirements. The contain “how to” instructions for designers, manufacturers, and users. Standards promote safety, reliability, productivity, and efficiency in almost every industry that relies on engineering components or equipment. Standards can run from a few paragraphs to hundreds of pages, and are written by experts with knowledge and expertise in a particular field who sit on many committees.

You will have to use standards from different sources:

1.  Jagadeeswaran, I., Chandran, S. (2022). ISO 11135: Sterilization of Health-Care Products—Ethylene Oxide, Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices. In: Timiri Shanmugam, P.S., Thangaraju, P., Palani, N., Sampath, T. (eds) Medical Device Guidelines and Regulations Handbook. Springer, Cham. https://link.springer.com/chapter/10.1007/978-3-030-91855-2_9

2.  Class related Standards are in ANSI Standards Connect -  you will find ISO 14971, 2d ed, 2007, Medical Devices there and others; You will have to register here before you can read the standard.  You will then be immediately connected to ANSI Standards Connect - click on "View My Documents" on the right column and you can refine the search by selecting ISO on the left and then scroll through the documents and click on View.  You can search the document for specific terms or coverage by entering "CTRL F"

3.  Other COVID related documents are also available from other sources.

4.  ASTM Standards & Engineering Digital Library  - to be searched - for F04.15

5.  Check in your Canvas source for other standards from ANSI

If you need a specific standard for this class that is not in ASTM Compass or in ANSI Standards Connect at UCI, please contact Julia Gelfand, Engineering Librarian at jgelfand@uci.edu and provide full citation to standard so that it can be obtained for you.

For additional information about standards and specifications, please consult Standards Guide or contact Engineering Librarian

For visual images you may want to consult sources such as the following sources or consult the Visual Arts: Images Resource Guide and make sure that you have proper rights to use or copy images - that they are Open Access or not copyrighted::

You may want to visit the Biomedical Engineering Research Guide.  These extracted resources are likely to be helpful:

• Concise Medical Dictionary, 8th ed., 2010
• Use this resource to better understand medical & clinical terms used in your reading & research
• WebMD

  More consumer and point-of-care oriented.

• Cancer Facts & Figures, 2020
• Handbook of Materials for Medical Devices, 2003
• Medical Device Link - The platform website for the medical device industry, provides news, information, employment and recruiting services, as well as collaborative opportunities for people who design, manufacture, and market medical devices.
• Plunkett Research Online

  Under the Health Care industry sector, there are updates like this that profile global initiatives and activities that can be researched further.
• Factiva - This fulltext business database of trade papers and magazines may indeed support your topics if searched broadly with geography inserted in search query. Default is 3 month search so for longer periods, please remember to alter search accordingly.\
• Gartner Campus Access - Gartner research highlights complex IT issues and emerging technologies and industry trends.  Highly sophisticated “hypecycles” chronicle influences and compliment other authoritative Garner research, insights and analytics with reports, white papers and webinars.

• Gates Foundation in Grand Challenges in Global Health
• Institute of Medicine, Board on Global Health

  Publications focused on global health
• Global Market Information Database (GMID)

  Restricted to UCI affiliates and you must click through license agreement. Issued by Euromonitor providing consumer market data on over 350 consumer products in 52 countries. You may want to click through to Health & Wellness under Industries, and then under Consumer Health for a specific geography
• Global Health Technologies Coalition

  Points to many sources that are working on several assignments similiar to the ones for this project.
• NIH Fact Sheets on Point of Care Diagnostic Testing

  Point-of-care testing allows patient diagnoses in the physician’s office, an ambulance, the home, the field, or in the hospital. The results of care are timely, and allow rapid treatment to the patient. Empowering clinicians to make decisions at the “point-of-care” has the potential to significantly impact health care delivery and to address the challenges of health disparities. The success of a potential shift from curative medicine, to predictive, personalized, and preemptive medicine could rely on the development of portable diagnostic and monitoring devices for point-of-care testing.
• Point-of-Care Diagnostics

  Demonstrates how a new company rolls out a diagnostic platform.
• CAB Direct

  Major database for global & world health. Indexes journal articles and conference literature. Consult Library Search by source or title of journal noted containing the article referenced or indexed.