Certified Industrial Sterilization Specialist (CISS)
Overview
CISS has expertise in the science of sterilization (including but not limited to microbiology, physics, and chemistry), knowledge of sterilization processing, quality management systems, risk management and regulatory requirements.The CISS program is a two-test process including a:
- Sterilization core exam including 75 multiple-choice questions
- A choice of one of the following specialty exams listed below:
- Ethylene Oxide
- Moist Heat
- Radiation
- The specialty exam consists of 50 multiple-choice questions.
Candidate Eligibility
Candidates must meet one of the following options to be eligible to sit for the CISS exams:
- Bachelor's degree (BS or BA in science or engineering field) AND 3 years of full-time, post baccalaureate work experience within the past 5 years in the appropriate exam specialty area.
- Bachelor's degree (BS or BA) with 20 semester hours or 30 quarter hours of course work in microbiology or related field AND 3 years of fulltime, post baccalaureate work experience within the past 5 years in the appropriate exam specialty area.
- High school graduate with 20 academic credits awarded for participation in workshops sponsored by AAMI or other appropriate organizations in the sterilization area AND 7 years of full-time work experience within the past 10 years in the appropriate exam specialty area.
Individuals can take the core and specialty exam in the same testing window.
Work Experience
The candidate must have experience relevant to the area in which certification is being sought. Relevant experience is experience in which most of the candidate's duties are in the area in which he/she is seeking certification. This experience must contribute to the candidate's ability to perform the effective operation and/or validation of a sterilization process. Please submit as many employers as needed to document the amount of time required under your preferred eligibility path. If experience from more than one employer is needed, references from former direct supervisors may be submitted in conjunction with the reference from your current supervisor.
Certified Industrial Sterilization Specialist Core Exam Content Outline
A. Ensure assessment of the sterilization process
for impact on product safety, functionality,
quality, and performance
B. Identify the steps of sterilization
C. Assess the adequacy of manufacturing
environmental controls
D. Assist in the design of products/packaging for
sterilization
E. Design sterilization processes
F. Determine the microbiological qualification
method
G. Develop Process Challenge Devices (PCDs)
H. Establish a load configuration
I. Establish parameters of the sterilization process
J. Establish product groups
K. Establish the rationale for the product sterility
assurance level
L. Establish tolerances of the sterilization process
M. Interpret bioburden data
N. Qualify microbiological effectiveness of the
process (radiation)
O. Select biological indicators
P. Select the correct sterilization process for the
product
A. Adhere to compliance regulations
B. Assemble sterilization data to support regulatory
requirements
C. Audit sterilization providers
D. Establish procedures for incoming sterilization
supplies (e.g., gas, dosimeters, biological
indicators, chemical indicators)
E. Interface with contract organizations (e.g.,
laboratories, sterilizers)
F. Interface with internal departments (e.g., R&D,
regulatory, packaging)
G. Interpret regulatory requirements
H. Perform GAP analyses to reflect changes in
regulatory requirements and standards
I. Process technical agreements
J. Support regulatory inspections
K. Update internal documents to reflect changes in
regulatory requirements and standards
L. Write technical rationales
A. Develop a sterilization procedure that can be
followed by sterilization personnel
B. Ensure equipment is calibrated prior to use
C. Ensure processed and non-processed product
segregation
D. Ensure sterilization procedures are followed
E. Establish acceptance criteria for routine
sterilization process
F. Interpret environmental data
G. Investigate microbiology issues
H. Assess the impact of process non-conformance
I. Review routine process records
J. Troubleshoot process anomalies
A. Assess the adequacy of the calibration program
for sterilization equipment
B. Assess the adequacy of the preventive
maintenance program for sterilization equipment
C. Select the proper sterilization agent for the
target device
D. Ensure the microbiologic methods are
appropriate
E. Identify the equipment to be used in the process
F. Perform process characterization
G. Adhere to safety requirements
A. Analyze validation results
B. Determine the locations of routine process
monitors (e.g., biological indicators, dosimeters,
chemical indicators)
C. Determine the placement of validation process
monitors
D. Develop sterilization procedures for validation
E. Ensure equipment is calibrated prior to use
F. Establish a validation process
G. Ensure the microbiologic methods are validated
H. Establish acceptance criteria for validation
I. Perform sterilization validation
J. Qualify microbiological effectiveness of the
process (non-radiation)
K. Assess that the process does not adversely
affect the product functionality
L. Qualify the equipment
M. Qualify the process is reproducible
N. Review sterilization residuals for adverse levels
O. Review validation data
P. Write sterilization validation protocols
Q. Write validation reports
The CISS Core exam is a two-hour closed book exam consisting of 75 multiple choice questions.
Candidates will be allowed to bring a scientific, non-printing calculator to use during the exam. Cell phones, iPads or other electronic devices that have internet capabilities or cameras are not allowed into the testing room.
Candidate performance on the exam is evaluated using a criterion-referenced method. This is a method where candidates are evaluated against a predetermined standard (cut score) rather than relative to each other. Your peers, the ACI Board, and its committees set this standard by evaluating the difficulty of each test question against the expectations for what an entry-level professional should know and be able to do. They use a common method for evaluating items and determining the passing standard (modified Angoff method).
Certified Industrial Sterilization Specialist Specialty Exam Content Outline
A. Assess change to process
B. Assess change to product/package
C. Assess process equivalence
D. Document rationale for product adoption
E. Establish requalification criteria
F. Evaluate sterilization process anomalies (e.g. residuals,
wet packs, blown-seals)
G. Investigate product complaints (e.g. sterility, functionality)
H. Perform periodic process requalification
I. Perform periodic process review
J. Recognize opportunities to optimize the process
A. Ensure assessment of the sterilization process for impact on product safety, functionality, quality, and performance
B. Identify the steps of sterilization
C. Assess the adequacy of manufacturing environmental controls
D. Assist in the
design of products/packaging for sterilization
E. Design sterilization processes
F. Determine the microbiological qualification method
G. Develop Process Challenge Devices (PCDs)
H. Establish a load configuration
I. Establish
parameters of the sterilization process
J. Establish product groups
K. Establish the rationale for the product sterility assurance level
L. Establish tolerances of the sterilization process
M. Interpret bioburden data
N. Qualify
microbiological effectiveness of the process (radiation)
O. Select biological indicators
P. Select the correct sterilization process for the product
A. Develop a sterilization procedure that can be followed by sterilization personnel
B. Ensure equipment is calibrated prior to use
C. Ensure processed and non-processed product segregation
D. Ensure sterilization procedures are followed
E. Establish acceptance criteria for routine sterilization process
F. Interpret environmental data
G. Investigate microbiology issues
H. Assess the impact of process non-conformance
I. Review routine process records
J. Troubleshoot
process anomalies
A. Assess the adequacy of the calibration program for sterilization equipment
B. Assess the adequacy of the preventive maintenance program for sterilization equipment
C. Select the proper sterilization agent for the target device
D. Ensure
the microbiologic methods are appropriate
E. Identify the equipment to be used in the process
F. Perform process characterization
G. Adhere to safety requirements
A. Analyze validation results
B. Determine the locations of routine process monitors (e.g. biological indicators, dosimeters, chemical indicators)
C. Determine the placement of validation process monitors
D. Develop sterilization procedures
for validation
E. Ensure equipment is calibrated prior to use
F. Establish a validation process
G. Ensure the microbiologic methods are validated
H. Establish acceptance criteria for validation
I. Perform sterilization validation
J. Qualify microbiological effectiveness of the process (non-radiation)
K. Assess that the process does not adversely affect the product functionality
L. Qualify the equipment
M. Qualify the process is reproducible
N. Review
sterilization residuals for adverse levels
O. Review validation data
P. Write sterilization validation protocols
Q. Write validation reports
The CISS Specialty exams are a one-hour closed book exam consisting of 50 multiple choice questions.
Candidates will be allowed to bring a scientific, non-printing calculator to use during the exam. Cell phones, iPads or other electronic devices that have internet capabilities or cameras are not allowed into the testing room.
Candidate performance on the exam is evaluated using a criterion-referenced method. This is a method where candidates are evaluated against a predetermined standard (cut score) rather than relative to each other. Your peers, the ACI Board, and its committees set this standard by evaluating the difficulty of each test question against the expectations for what an entry-level professional should know and be able to do. They use a common method for evaluating items and determining the passing standard (modified Angoff method).