AAMI ST90 2017 R2024
$31.42
ANSI/AAMI ST90:2017/(R)2024 – Processing of health care products—Quality management systems for processing in health care facilities
| Published By | Publication Date | Number of Pages |
| AAMI | 2017 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI ST90:2017/(R)2024; Processing of health care products—Quality management systems for processing in health care facilities |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents Page |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 11 | Foreword |
| 13 | Introduction |
| 14 | 1 Scope 1.1 Inclusions 1.2 Exclusions |
| 15 | 2 Normative references |
| 16 | 3 Definitions and abbreviations |
| 19 | 4 Quality management system 4.1 General considerations 4.2 Documentation requirements 4.2.1 General considerations 4.2.2 Quality manual 4.2.3 Control of documents |
| 20 | 4.2.4 Control of records |
| 21 | 5 Management responsibility 5.1 Management commitment 5.2 Quality policy 5.3 Planning 5.3.1 Quality objectives 5.3.2 Quality management system planning 5.4 Responsibility, authority, and communication 5.4.1 Responsibility and authority |
| 22 | 5.4.2 Management representative 5.4.3 Internal communication 5.5 Management review 5.5.1 General considerations 5.5.2 Review input (agenda items) 5.5.3 Review output (meeting minutes) |
| 23 | 6 Resource management 6.1 Provision of resources 6.2 Human resources 6.2.1 General considerations 6.2.2 Competency, education, and training 6.3 Infrastructure 6.4 Work environment |
| 25 | 7 Product realization 7.1 Planning for new devices, equipment, and materials 7.2 Determining customer requirements 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 |
| 26 | 7.3 Developing surgical sets and other device processing techniques 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 |
| 27 | 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 7.4.1 Purchasing process |
| 28 | 7.4.2 Purchasing information 7.4.3 Verification of purchased product 7.5 Processing and servicing 7.5.1 Control of processing and servicing 7.5.1.1 General requirements |
| 29 | 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 7.5.2.1 General requirements 7.5.2.2 Particular requirements for sterile surgical instrumentation and other medical devices |
| 30 | 7.5.3 Identification and traceability 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 |
| 31 | 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 |
| 33 | 8 Measurement, analysis, and improvement 8.1 General considerations 8.2 Monitoring and measurement 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 |
| 34 | 8.4 Analysis of data 8.5 Improvement 8.5.1 Continuous improvement 8.5.2 Corrective action |
| 35 | 8.5.3 Preventive action |
| 36 | Annex A (informative) Document and record retention A.1 Introduction A.2 General considerations A.3 Control of documents and records |
| 37 | A.4 Documents and records to be maintained by the sterile processing department |
| 38 | Annex B (informative) Risk management B.1 Introduction B.2 General considerations B.3 Risk management concepts |
| 39 | B.3.1 Risk identification B.3.2 Root cause of risk B.3.3 Assessment of risk (measurement and evaluation) B.3.3.1 Measurement |
| 40 | B.3.3.2 Evaluation Figure B.1—Qualitative severity levels by semi-qualitative probability levels B.3.4 Risk mitigation B.3.4.1 Residual risks B.3.5 Risk monitoring |
| 41 | Annex C (normative) Product quality assurance testing for steam sterilizationin health care facilities C.1 Introduction C.2 Use of normal production cycles C.3 Identification of product families and master products |
| 42 | C.4 Use of chemical and biological indicators C.5 Placement of master products C.6 Load configuration |
| 43 | C.7 Drying time and cooling C.8 Test results C.9 Frequency of testing |
| 44 | Figure C.1—Sample outline of a steam sterilization product quality assurance testing protocol |
| 45 | Annex D (informative) Six major steps in creating a quality management system D.1 Introduction D.2 QMS structure D.3 QMS inputs |
| 46 | D.4 QMS outputs D.5 Creating a quality management system |
| 48 | Bibliography |
