| 标准号 | 名称 | 采信 |
|---|
| ANSIAAMI NS4 | Transcutaneous Electrical Nerve Stimulators | FDA |
| ANSIAAMI ST8 | Hospital steam sterilizers | FDA |
| ANSIAAMI EC12 | Disposable ECG electrodes | FDA |
| ANSIAAMI BP22 | Blood pressure transducers | FDA |
| ANSIAAMI ST24 | Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources inten | FDA |
| ANSIAAMI CN27 | General requirements for Luer activated valves (LAVs) incorporated into medical devices for intr | FDA |
| ANSIAAMI ST40 | Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities | FDA |
| ANSIAAMI ST41 | Ethylene oxide sterilization in health care facilities: Safety and effectiveness | FDA |
| ANSIAAMI ST50 | Dry heat (heated air) sterilizers | FDA |
| ANSIAAMI EC53 | ECG trunk cables and patient leadwires | FDA |
| ANSIAAMI ID54 | Enteral feeding set adapters and connectors | FDA |
| ANSIAAMI EC57 | Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithm | FDA |
| ANSIAAMI ST58 | Chemical sterilization and high-level disinfection in health care facilities | FDA |
| ANSIAAMI ST65 | Processing of reusable surgical textiles for use in health care facilities | FDA |
| ANSIAAMI ST67 | Sterilization of health care products - Requirements and guidance for selecting a sterility assu | FDA |
| ANSIAAMI PB70 | Liquid barrier performance and classification of protective apparel and drapes intended for use | FDA |
| ANSIAAMI ST72 | Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing | FDA |
| ANSIAAMI HE75 | Human factors engineering - Design of medical devices | FDA |
| ANSIAAMI PC76 | Active implantable medical devices - Requirements and test protocols for safety of patients with | FDA |
| ANSIAAMI ST77 | Containment devices for reusable medical device sterilization | FDA |
| ANSIAAMI ST79 | (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health | FDA |
| ANSIAAMI CI86 | Cochlear implant systems: Requirements for safety, functional verification, labeling and reliabi | FDA |
| ANSIAAMI SW87 | Application of quality management system concepts to medical device data systems | FDA |
| ANSIAAMI SW91 | Classification of defects in health software | FDA |
| ANSIAAMI ST91 | Flexible and semi-rigid endoscope processing in health care facilities | FDA |
| ANSIAAMI SW96 | Standard for medical device security - Security risk management for device manufacturers | FDA |
| ANSIAAMI ST98 | Cleaning validation of health care products - Requirements for development and validation of a c | FDA |
| ANSIAAMI 2700-1 | Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the | FDA |
| ANSIAAMI 2700-2-1 | Medical devices and medical systems - Essential safety and performance requirements for equipmen | FDA |
| ANSIAAMI ES60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential perfo | FDA |
| ANSIAAMI ES60601-1-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential perfo | FDA |
| ANSIAAMI HA60601-1-11 | Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential p | FDA |
| ANSIAAMI HA60601-1-11-1-11 | Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential p | FDA |