Minimum Acceptable Compliance % (Technical Specifications of Medical Devices)
Imran Rana
14 Posts
I was browsing through the AQL for the Medical device industry regulation guidelines (EU & Japanese) and found the following, can one confidently, implement the below AQL, or there any recognized AQL for manufacturing as per the given categories;
1. Human Sensitive AQL; Defects when accepted will harm users. Such defects are unacceptable and limits of non-compliance may be set from 0.00 to 0.25 percent max.
2. Critical Defects AQL; Defects may possibly harm users if used on a prolonged basis. So, the defects may be kept at 0.65 % AQL.
3. Major Defects AQL: The defects usually are not acceptable by users as they are likely to fail product use. So, the AQL for the major defects category is 2.5%.
4. Minor Defects AQL; Defects not likely to reduce materially the usability of the product for its intended purpose but that differ from the specified standard. Some users still buy such products. So, the AQL for minor defects is 4%.

Highly appreciate the feedback and further discussion,