AAMI Collection
This collection contains documents from the following standards organization(s): Association for the Advancement of Medical Instrumentation < < 1 2 3
| AAMI TIR19218 | EN-Medical devices - Coding structure for adverse event type and cause | |
| AAMI TIR20 | EN-PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION-Cited by FDA as "relevant guidance" for ANSI/AAMI/ISO 11135: 1994 | |
| AAMI TIR21 | EN-Systems Used to Forecast Remaining Pacemaker Battery Service Life | |
| AAMI TIR22 | EN-Guidance for ANSI/AAMI/ISO 11607 Packaging for terminally sterilized medical devices- Part 1 and Part 2:2006-Incorporates Amendment 1: 2008 | |
| AAMI TIR23 | EN-Signal Averaging | |
| AAMI TIR24 | EN-Acquisition and use of physiologic waveform databases for testing of medical devices | |
| AAMI TIR25 | EN-Chemical indicators- Guidance for the selection use and interpretation of results | |
| AAMI TIR28 | EN-Product adoption and process equivalence for ethylene oxide sterilization | |
| AAMI TIR30 | EN-A Compendium of processes materials test methods and acceptance criteria for cleaning reusable medical devices | |
| AAMI TIR31 | EN-PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARD FACILITIES | |
| AAMI TIR32 | EN-Medical device software risk management | |
| AAMI TIR33 | EN-Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method VDmax | |
| AAMI TIR34 | EN-Water for the reprocessing of medical devices | |
| AAMI TIR35 | EN-Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits-Former designation: AAMI ST31 AAMI ST32 and AAMI TIR5 | |
| AAMI TIR36 | EN-Validation of software for regulated processes | |
| AAMI TIR37 | EN-Sterilization of health care products-Radiation- Guidance on sterilization of human tissue-based products | |
| AAMI TIR39 | EN-Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices | |
| AAMI TIR4 | EN-Apnea Monitoring by Means of Thoracic Impedance Pneumography | |
| AAMI TIR40 | EN-Sterilization of health care products-Radiation-Guidance on dose setting utilizing a Modified Method 2 | |
| AAMI TIR60878 | EN-Graphical symbols for electrical equipment in medical practice | |
| AAMI TIR62296 | EN-Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements | |
| AAMI TIR62348 | EN-Mapping between the clauses of the third edition of IEC 60601-1 and the 1988 edition as amended | |
| AAMI TIR62354 | EN-General testing procedures for medical electrical equipment | |
| AAMI TIR80002-1 | EN-Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software | |
| AAMI TIR9 | EN-Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring |
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