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ANSI/AAMI ST90:2017/(R)2024 - Processing of health care products—Quality management systems for processing in health care facilities, 2017
- ANSI/AAMI ST90:2017/(R)2024; Processing of health care products—Quality management systems for processing in health care facilities
- Title page
- AAMI Standard
- Copyright information
- Contents Page
- Glossary of equivalent standards
- Committee representation
- Foreword
- Introduction
- 1 Scope [Go to Page]
- 1.1 Inclusions
- 1.2 Exclusions
- 2 Normative references
- 3 Definitions and abbreviations
- 4 Quality management system [Go to Page]
- 4.1 General considerations
- 4.2 Documentation requirements [Go to Page]
- 4.2.1 General considerations
- 4.2.2 Quality manual
- 4.2.3 Control of documents
- 4.2.4 Control of records
- 5 Management responsibility [Go to Page]
- 5.1 Management commitment
- 5.2 Quality policy
- 5.3 Planning [Go to Page]
- 5.3.1 Quality objectives
- 5.3.2 Quality management system planning
- 5.4 Responsibility, authority, and communication [Go to Page]
- 5.4.1 Responsibility and authority
- 5.4.2 Management representative
- 5.4.3 Internal communication
- 5.5 Management review [Go to Page]
- 5.5.1 General considerations
- 5.5.2 Review input (agenda items)
- 5.5.3 Review output (meeting minutes)
- 6 Resource management [Go to Page]
- 6.1 Provision of resources
- 6.2 Human resources [Go to Page]
- 6.2.1 General considerations
- 6.2.2 Competency, education, and training
- 6.3 Infrastructure
- 6.4 Work environment
- 7 Product realization [Go to Page]
- 7.1 Planning for new devices, equipment, and materials
- 7.2 Determining customer requirements [Go to Page]
- 7.2.1 Requirements related to device availability and turnaround time
- 7.2.2 Review of requirements related to the device, equipment, or material
- 7.2.3 Communication with customers
- 7.3 Developing surgical sets and other device processing techniques [Go to Page]
- 7.3.1 Planning for design and development of surgical sets and other medical devices
- 7.3.2 Design and development inputs for surgical sets and other medical devices
- 7.3.3 Design and development outputs for surgical sets and other medical devices
- 7.3.4 Design and development review of surgical sets and other medical devices
- 7.3.5 Design and development verification for surgical sets and other medical devices
- 7.3.6 Design and development product quality assurance testing
- 7.3.7 Control of design and development changes for surgical sets and other medical devices
- 7.4 Purchasing [Go to Page]
- 7.4.1 Purchasing process
- 7.4.2 Purchasing information
- 7.4.3 Verification of purchased product
- 7.5 Processing and servicing [Go to Page]
- 7.5.1 Control of processing and servicing [Go to Page]
- 7.5.1.1 General requirements
- 7.5.1.2 Cleanliness of product and contamination control
- 7.5.1.3 Installation activities
- 7.5.1.4 Servicing activities
- 7.5.1.5 Particular requirements for sterile medical devices
- 7.5.2 Verification of processes [Go to Page]
- 7.5.2.1 General requirements
- 7.5.2.2 Particular requirements for sterile surgical instrumentation and other medical devices
- 7.5.3 Identification and traceability [Go to Page]
- 7.5.3.1 Identification
- 7.5.3.2 Traceability: General requirements
- 7.5.3.3 Traceability: Particular requirements for implantable and active implantable medical devices
- 7.5.3.4 Traceability: Particular requirements for devices, equipment, and materials used in high-risk cases
- 7.5.3.5 Traceability: Particular requirements for loaned/vendor sets
- 7.5.3.6 Identification of status
- 7.5.3.7 Tracking of health care products and accessory equipment
- 7.5.4 Customer-owned and loaned/vendor property
- 7.5.5 Preservation of product
- 7.6 Control of monitoring and measuring equipment
- 8 Measurement, analysis, and improvement [Go to Page]
- 8.1 General considerations
- 8.2 Monitoring and measurement [Go to Page]
- 8.2.1 Customer satisfaction
- 8.2.2 Internal audit
- 8.2.3 Monitoring and measurement of processes
- 8.2.4 Monitoring and measurement of medical devices and equipment
- 8.3 Control of nonconforming processes, medical devices, and equipment
- 8.4 Analysis of data
- 8.5 Improvement [Go to Page]
- 8.5.1 Continuous improvement
- 8.5.2 Corrective action
- 8.5.3 Preventive action
- Annex A (informative) Document and record retention [Go to Page]
- A.1 Introduction
- A.2 General considerations
- A.3 Control of documents and records
- A.4 Documents and records to be maintained by the sterile processing department
- Annex B (informative) Risk management [Go to Page]
- B.1 Introduction
- B.2 General considerations
- B.3 Risk management concepts
- B.3.1 Risk identification
- B.3.2 Root cause of risk
- B.3.3 Assessment of risk (measurement and evaluation) [Go to Page]
- B.3.3.1 Measurement
- B.3.3.2 Evaluation [Go to Page]
- Figure B.1—Qualitative severity levels by semi-qualitative probability levels
- B.3.4 Risk mitigation [Go to Page]
- B.3.4.1 Residual risks
- B.3.5 Risk monitoring
- Annex C (normative) Product quality assurance testing for steam sterilizationin health care facilities [Go to Page]
- C.1 Introduction
- C.2 Use of normal production cycles
- C.3 Identification of product families and master products
- C.4 Use of chemical and biological indicators
- C.5 Placement of master products
- C.6 Load configuration
- C.7 Drying time and cooling
- C.8 Test results
- C.9 Frequency of testing [Go to Page]
- Figure C.1—Sample outline of a steam sterilization product quality assurance testing protocol
- Annex D (informative) Six major steps in creating a quality management system [Go to Page]
- D.1 Introduction
- D.2 QMS structure
- D.3 QMS inputs
- D.4 QMS outputs
- D.5 Creating a quality management system
- Bibliography [Go to Page]