Opubo G. Benebo, please tell us more about your plans. I visited your site and didn't see anything about sterilization.

Opubo G. Benebo I guess i should have given the link:
https://www.enhknow.com/adoptrbrokerage/managedventures/bmmedtechsterilizer.php

Not much to go on there. What more can you tell us? If you're looking for a medical device designer, let us know.

Opubo G. Benebo Oh well thank you then.

Dr. Patrick Druggan all of them

John Gillespy You might start with the FDA Guidance Document ("Sterilizers Intended For Use in Health Care Facilities"), both the 1993 original and 1995 addendum.

If you are planning to manufacture equipment for medical device sterilization, you will need to consider one or more of the standards developed by ISO TC 198. Without knowing more about your intended technology I cannot be more specific, but if you search www.iso.org for TC198 you will find a list of their published standards.

Opubo G. Benebo Thank you Paul Dixon and Thank you John Gillespy. After reading them and others that might be suggested, the choices and the guiding reasonings shall be observed here.

Beluh Mabasa Ginting If you plan to manufacture equipment to sterilize a medical device, then your first step should be to determine what sterilization method you will use for example Autoclaving, Ethylene Oxide (EtO) and Gamma Irradiation (the standards developed by ISO/TC 198). The more recently introduced systems involve low-temperature gas plasma and vapor phase sterilant. Determination of the above sterilization method should be based on the results of an analysis of the compatibility of each medical device particularly the chemical composition of the materials (the standards developed by ISO/TC 194 for example ISO 10993-18), with the process parameters of the sterilization method and the chemicals used, is necessary.

Opubo G. Benebo Thank you, Beluh Mabasa Ginting for advising for considering the ISO 194 in addition to the 198 that Paul Dixon had earlier advised to be considered. As a chemical Engineer I have several options to adopt for the sterilization method. I have, of course, done more work in the areas of reactive sterilization and irradiation sterilization some of the latter of which are documented in a manuscript "Radiolytic Bioreactor Analysis" (https://www.okumaye.com/books/Medical/Radiolytic-Bioreactors-Analysis-Opubo-Benebo.php); but thank you all the same for the specificity on the methods. I appreciate it much.

Dymphy van der Wilk The standards that apply depend on which surgical tool you'll sterilize. Some of the standards concerning sterilisation that we have identified for one of our surgical instruments are: NEN-EN-ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices, and NEN-EN-ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.

You can also reduce your expenses when purchasing these standards here: https://www.evs.ee/shop (I'm not a shareholder btw :), this is just a kind advice).

Opubo G. Benebo Dymphy van der Wilk, thank you for advising the two ISO Standards: NEN-EN-ISO 17664:2004 and NEN-EN-ISO 17665-1:2006, for consideration in the finalizing prep for the Sterilizations Machines. I appreciate it much.

I have a prototype and the fda desperately needs a current addendum

And don't forget that for the 510 K submission you will need for compliance CFR:820 and CFR 801 IFUs.

Opubo G. Benebo Jamie Richardson, thank for the guidance, we will certainly prep for the required compliance stipulations. I appreciate your advice much.