Everyone has probably experienced at one time or another or knows someone that has felt the pains of bypassing steps in order to seemingly get to completion quicker to only realize that those missed steps actually created an even bigger emergency and setback.
We hear a lot from people in companies who are creating laser-based equipment or x-Ray based equipment. In today’s video, Steve Barcik Amstel, shares insights from common mistakes that you and your team can benefit from to create a solid path to market.
Link to video also available here: https://youtu.be/emQ3GnWwPNM
The ideal scenario is where somebody comes to us early in the process and allows us to do early evaluations and early tests. This is all part of our Conformity Discovery Process™ so when their equipment is finished it gets certified really easily.
And then sometimes we get into the opposite situation where the equipment has already been built and shipped. Then as we go to evaluate it, we might find that an interlock isn’t correct or something else is wrong. Yikes! This means that equipment sits at the client’s site for a long time until someone comes out with a redesign for that and then someone goes there and installs it.
So we are really happy to help early And… if you have gotten yourself in a bind we can help you with that too.
Be sure though next time we do those evaluations early.
Here are a few answers to some common questions that are important to consider throughout your process:
How to know if the laser we are buying for a company is safe?
How to get your laser product certified?
Laser product certification must follow particular path including the below standards.
UL/ANSI/IEC 60825 – 1 safety for lasers and the new standard 62368-1
CDRH Filings laser submission report
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER J–RADIOLOGICAL HEALTH
PART 1040 — PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
Sec. 1040.10 Laser products.
What about X-ray system certification?
How to get your x-ray product certified?
What are x-ray product standards?
What safety requirements are for x-ray cabinet x-rays?
X-ray standards for industrial x-rays include the following:
FDA’s radiation safety performance standard for cabinet x-ray systems requires specific performance standards in specific safety and interlocking standards be met in order for the system to be safe. We can help you select those parts into evaluations to ensure that your equipment meets the standards.
How to get your x-ray product certified listed? You follow the above standards and you file with CRH for approval.
The Manufacturers of cabinet x-ray systems and industrial x-rays are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005: the systems must be designed to be safe, shielded, provide labeling, and provide indicator lights and signs to indicate when the x-rays emitting. The standard is pretty dense and has lots requirements and it, including the fact that all safety interlocks must be safety rated for the use. An X illicitly unusual requirement is that the switch and interlocking means much must actually break power to the x-ray power supply source. Good luck on figuring that one out on your own!
Reports are required for each Cabinet X-Ray model and type for the manufacturer’s and end users Manufacturers or Industry. Whether you need a submission report, or a use permit you must have the required information and complete the below data.
- Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40
- Guide for Filling Annual Reports for X-Ray Components and Systems
As you can see, there are many different layers to consider when designing your product. We are always a resource and will help to simplify the process.
Please be sure to like and subscribe to get notifications of the next videos in this training. And if you have questions about getting your product to market please get into touch with us here at High Tech Design Safety. https://hightechdesignsafety.com/