IAHCSMM CHL Certification – Chapter 22–25 Review
Questions
1. Qualification Testing that assesses the performance of a steam sterilizer in the
environment
in which it will be used before the equipment is approved for routine
use in the healthcare facility.
2. Validation Documented procedures performed by a medical device manufacturer
to estab-
lish that a process consistently yields a product complying with
predetermined specifications.
3. Verification Documented procedures performed in the users environment to
establish that
predetermined specifications have been met.
4. Lot (load) control number
1/
3
Questions
1. Qualification Testing that assesses the performance of a steam sterilizer in the
environment
in which it will be used before the equipment is approved for routine
use in the healthcare facility.
2. Validation Documented procedures performed by a medical device manufacturer
to estab-
lish that a process consistently yields a product complying with
predetermined specifications.
3. Verification Documented procedures performed in the users environment to
establish that
predetermined specifications have been met.
4. Lot (load) control number
1/
3
