AAMI
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AAMI TIR45:2023
Guidance on the use of agile practices in the development of medical device software
15.03.2023 - PDF - Englisch -
mehr dazu330,00 € -
AAMI TIR34971:2023
Application of ISO 14971 to machine learning in artificial intelligence—Guide
14.03.2023 - PDF - Englisch -
mehr dazu233,00 € -
AAMI/ISO 15223-1:2022:2023
Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
09.01.2023 - PDF - Englisch -
mehr dazu266,00 € -
AAMI/ISO TI:2022 (R2245)6: 2022
Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
27.12.2022 - PDF - Englisch -
mehr dazu189,00 € -
AAMI SW96:2023:2022
Standard for medical device security—Security risk management for device manufacturers
21.12.2022 - PDF - Englisch -
mehr dazu285,00 € -
AAMI/ISO 17664-1:2022
Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices
21.12.2022 - PDF - Englisch -
mehr dazu233,00 € -
AAMI ST98:2022
Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
22.08.2022 - PDF - Englisch -
mehr dazu259,00 € -
AAMI HA60601-1-11:2015 & A1:2021:2022
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015, MOD) CONSOLIDATED EDITION
22.08.2022 - PDF - Englisch -
mehr dazu277,00 € -
AAMI ES60601-1: 2005 & A1:2012 & A2:2021:2022
Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) CONSOLIDATED EDITION
22.08.2022 - PDF - Englisch -
mehr dazu1.168,00 € -
AAMI ST44 : 2002
Resistometers used for characterizing the performance of biological and chemical indicators
10.07.2022 - PDF - Englisch -
mehr dazu86,00 € -
AAMI/ISO TIR 11137-4:2022
Sterilization of health care products-Radiation-Part 4: Guidance on process control
12.06.2022 - PDF - Englisch -
mehr dazu276,00 € -
AAMI 2800-1-3:2022
Standard for Interoperable Item Integration Life Cycle (ANSI/AAMI/UL 2800-1-3:2022)
10.06.2022 - PDF - Englisch -
mehr dazu227,00 € -
AAMI 2800-1-2:2022
Standard for Interoperable Item Development Life Cycle (ANSI/AAMI/UL 2800-1-2:2022)
10.06.2022 - PDF - Englisch -
mehr dazu259,00 € -
AAMI 2800-1:2022
Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2022)
10.06.2022 - PDF - Englisch -
mehr dazu320,00 € -
AAMI 2800-1-1:2022
Standard for Risk Concerns for Interoperable Medical Products (ANSI/AAMI/UL 2800-1-1:2022)
10.06.2022 - PDF - Englisch -
mehr dazu276,00 € -
184,00 €
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AAMI 2700-2-1: 2022:2022
Medical devices and medical systems-Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging
22.04.2022 - PDF - Englisch -
mehr dazu259,00 € -
AAMI TIR104:2022
Guidance on transferring health care products between radiation sterilization sources
19.04.2022 - PDF - Englisch -
mehr dazu227,00 € -
AAMI CR34971:2022
Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
01.04.2022 - PDF - Englisch -
mehr dazu227,00 € -
AAMI HA60601-1-11:2015/A1:2021:2022
Amendment 1, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015, MOD)
20.03.2022 - PDF - Englisch -
mehr dazu125,00 € -
AAMI HIT1000-1: 2022:2022
Safety and effectiveness of health IT software and systems-Part 1: Fundamental concepts, principles, and requirements
01.03.2022 - PDF - Englisch -
mehr dazu259,00 € -
AAMI ES60601-1: 2005/A2:2021:2022
Amendment 2, Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
01.03.2022 - PDF - Englisch -
mehr dazu268,00 € -
251,00 €
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AAMI ST91:2021
Flexible and semi-rigid endoscope processing in health care facilities
21.12.2021 - PDF - Englisch -
mehr dazu373,00 € -
AAMI/ISO CN27:2021
General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
06.12.2021 - PDF - Englisch -
mehr dazu220,00 € -
268,00 €
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AAMI CR510:2021
Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
24.09.2021 - PDF - Englisch -
mehr dazu125,00 € -
AAMI PC76:2021
Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
01.04.2021 - PDF - Englisch -
mehr dazu302,00 € -
AAMI TIR76:2021
Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method Vdmax SD-S
31.03.2021 - PDF - Englisch -
mehr dazu251,00 € -
AAMI TIR42:2021
Evaluation of particulate associated with vascular medical devices
31.03.2021 - PDF - Englisch -
mehr dazu251,00 € -
AAMI TIR43:2021
Ultrapure dialysis fluid for hemodialysis and related therapies
26.02.2021 - PDF - Englisch -
mehr dazu251,00 € -
AAMI/ISO 14155:2020
Clinical investigation of medical devices for human subjects - Good clinical practice
07.12.2020 - PDF - Englisch -
mehr dazu310,00 € -
AAMI/ISO 10993-16:2017:2020
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
06.11.2020 - PDF - Englisch -
mehr dazu144,00 € -
AAMI/ISO 10993-15:2019:2020
Biological evaluation of medical devices?Part 15: Identification and quantification of degradation products from metals and alloys
05.10.2020 - PDF - Englisch -
mehr dazu144,00 € -
AAMI TIR12:2020
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
17.09.2020 - PDF - Englisch -
mehr dazu268,00 € -
251,00 €
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AAMI/IEC 60601-2-39:2018:2020
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
26.08.2020 - PDF - Englisch -
mehr dazu220,00 € -
AAMI/IEC 60601-2-16:2018:2020
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
22.07.2020 - PDF - Englisch -
mehr dazu268,00 € -
AAMI HIT1000-4 (PS):2020
Safety and effectiveness of health IT software and systems - Part 4: Application of human factors engineering
07.07.2020 - PDF - Englisch -
mehr dazu24,00 € -
AAMI/ISO 8637-1:2017:2020
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
01.07.2020 - PDF - Englisch -
mehr dazu220,00 € -
AAMI/ISO 8637-2:2018:2020
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
01.07.2020 - PDF - Englisch -
mehr dazu179,00 € -
AAMI/IEC 62366-1: 2015+AMD1:2020 (Consolidated Text) (R2021)
Medical devices - Part 1: Application of usability engineering to medical devices, including Amendment 1
01.07.2020 - PDF - Englisch -
mehr dazu268,00 € -
AAMI/ISO 8637-3:2018:2020
Extracorporeal systems for blood purification - Part 3: Plasmafilters
01.07.2020 - PDF - Englisch -
mehr dazu179,00 € -
AAMI/ISO 10993-11:2017
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
27.04.2020 - PDF - Englisch -
mehr dazu220,00 € -
AAMI/ISO 10993-4:2017
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
27.04.2020 - PDF - Englisch -
mehr dazu268,00 € -
AAMI/ISO 10993-1:2018
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
27.04.2020 - PDF - Englisch -
mehr dazu268,00 € -
AAMI MP80601-2-49:2020
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
24.03.2020 - PDF - Englisch -
mehr dazu251,00 € -
AAMI/ISO TI (R2041)6:2020
Medical devices - Post-market surveillance for manufacturers
16.02.2020 - PDF - Englisch -
mehr dazu260,00 € -
310,00 €
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268,00 €
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Medical Devices - A Practical Guide, Advice from ISO/TC 210 (13485:2016)
Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
22.01.2020 - PDF - Englisch -
mehr dazu143,00 € -
AAMI/ISO 80369-1:2018
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
30.12.2019 - PDF - Englisch -
mehr dazu140,00 € -
AAMI/ISO 23500-1:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements
23.12.2019 - PDF - Englisch -
mehr dazu310,00 € -
AAMI/ISO 23500-2:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
23.12.2019 - PDF - Englisch -
mehr dazu251,00 € -
AAMI/ISO 23500-5:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
23.12.2019 - PDF - Englisch -
mehr dazu179,00 € -
AAMI/ISO 23500-4:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
23.12.2019 - PDF - Englisch -
mehr dazu220,00 € -
AAMI/ISO 23500-3:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
23.12.2019 - PDF - Englisch -
mehr dazu179,00 € -
179,00 €
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AAMI ST72:2019
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing, Includes Erratum (2020)
01.11.2019 - PDF - Englisch -
mehr dazu268,00 € -
AAMI/ISO 11138-7:2019
Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results
01.11.2019 - PDF - Englisch -
mehr dazu268,00 € -
AAMI/ISO 14117:2019
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
27.09.2019 - PDF - Englisch -
mehr dazu310,00 € -
AAMI TIR97:2019 (R2023)
Principles for medical device security - Postmarket risk management for device manufacturers
27.09.2019 - PDF - Englisch -
mehr dazu285,00 € -
AAMI TIR102:2019
U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
30.08.2019 - PDF - Englisch -
mehr dazu310,00 € -
AAMI ST67:2019
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
29.07.2019 - PDF - Englisch -
mehr dazu144,00 € -
AAMI/ISO 11737-2: 2019
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
11.07.2019 - PDF - Englisch -
mehr dazu179,00 € -
ANSI/AAMI 2700-1:2019
Medical Devices and Medical Systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
01.07.2019 - PDF - Englisch -
mehr dazu220,00 € -
AAMI TIR75:2019
Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
01.06.2019 - PDF - Englisch -
mehr dazu220,00 € -
AAMI/ISO 14971:2019
Medical devices - Application of risk management to medical devices
01.05.2019 - PDF - Englisch -
mehr dazu268,00 € -
AAMI EQ93:2019
Medical equipment management - Vocabulary used in medical equipment programs
18.04.2019 - PDF - Englisch -
mehr dazu125,00 € -
AAMI/ISO 81060-2:2019
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
22.03.2019 - PDF - Englisch -
mehr dazu251,00 € -
AAMI/IEC 60601-2-4:2010/A1:2018 (Consolidated Text)
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
30.01.2019 - PDF - Englisch -
mehr dazu310,00 € -
268,00 €
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AAMI/ISO 11607-2: 2019
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
01.01.2019 - PDF - Englisch -
mehr dazu144,00 € -
AAMI/ISO 11607-1: 2019
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
01.01.2019 - PDF - Englisch -
mehr dazu179,00 € -
268,00 €
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AAMI TIR68:2018 (R2022)
Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
30.09.2018 - PDF - Englisch -
mehr dazu227,00 € -
AAMI/IEC 60601-2-19:2009 (R2014) & A1:2016
Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
01.09.2018 - PDF - Englisch -
mehr dazu220,00 € -
AAMI/IEC 60601-2-20:2009 (R2014) & A1:2016
Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
01.09.2018 - PDF - Englisch -
mehr dazu251,00 € -
AAMI/ISO TI(R2190)0:2018
Guidance for uncertainty analysis regarding the application of ISO/TS 10974
19.07.2018 - PDF - Englisch -
mehr dazu144,00 € -
AAMI TIR77:2018
Technical Information Report Sorbent-based regenerative hemodialysis systems
08.06.2018 - PDF - Englisch -
mehr dazu179,00 € -
AAMI/ISO TI(R1097)4:2018
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
01.05.2018 - PDF - Englisch -
mehr dazu333,00 € -
AAMI TIR67:2018 (R2022)
Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
25.04.2018 - PDF - Englisch -
mehr dazu276,00 € -
AAMI TIR40:2018 (R2022)
Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
31.01.2018 - PDF - Englisch -
mehr dazu189,00 € -
AAMI/ISO 11737-1:2018
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
24.01.2018 - PDF - Englisch -
mehr dazu190,00 € -
179,00 €
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AAMI/ISO 13408-2:2018
Aseptic processing of health care products - Part 2:Sterilizing filtration
17.11.2017 - PDF - Englisch -
mehr dazu144,00 € -
AAMI/ISO 11137-3:2017
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine
06.10.2017 - PDF - Englisch -
mehr dazu144,00 € -
AAMI/ISO 80369-7:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
27.09.2017 - PDF - Englisch -
mehr dazu268,00 € -
144,00 €
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AAMI/ISO TI(R1549)9:2017
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
27.08.2017 - PDF - Englisch -
mehr dazu173,00 € -
AAMI/ISO 17664:2017
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
18.08.2017 - PDF - Englisch -
mehr dazu220,00 € -
AAMI/ISO TIR80002-2:2017
Medical device software - Part 2: Validation of software for medical device quality systems
18.08.2017 - PDF - Englisch, Französisch -
mehr dazu310,00 € -
144,00 €
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220,00 €
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AAMI/ISO 11138-2:2017
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
01.08.2017 - PDF - Englisch -
mehr dazu125,00 € -
AAMI/ISO 11138-4:2017
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
01.08.2017 - PDF - Englisch -
mehr dazu125,00 € -
AAMI/ISO 11138-1:2017
Sterilization of health care products - Biological indicators - Part 1: General requirements
01.08.2017 - PDF - Englisch -
mehr dazu268,00 € -
AAMI/ISO 11138-3:2017
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
01.08.2017 - PDF - Englisch -
mehr dazu125,00 € -
AAMI/ISO 11138-5:2017
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
01.08.2017 - PDF - Englisch -
mehr dazu125,00 € -
AAMI/ISO 16142-2:2017
Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
31.07.2017 - PDF - Englisch -
mehr dazu268,00 € -
AAMI ST90:2017
Processing of health care products - Quality management systems for processing in health care facilities
18.07.2017 - PDF - Englisch -
mehr dazu251,00 € -
AAMI/IEC 60601-2-2:2017
Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
30.06.2017 - PDF - Englisch -
mehr dazu268,00 € -
AAMI TIR21:2017 (R2020)
Systems Used to Forecast Remaining Pacemaker Battery Service Life
11.06.2017 - PDF - Englisch -
mehr dazu268,00 € -
AAMI/ISO 25539-1:2017
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
25.05.2017 - PDF - Englisch -
mehr dazu220,00 € -
AAMI/ISO 14708-3:2017
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
02.03.2017 - PDF - Englisch -
mehr dazu251,00 € -
ANSI/AAMI/ISO 10993-6:2016
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
10.01.2017 - PDF - Englisch -
mehr dazu179,00 € -
AAMI CI86:2017
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
06.01.2017 - PDF - Englisch -
mehr dazu310,00 € -
179,00 €
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AAMI TIR28:2016 (R2020)
Product adoption and process equivalency for ethylene oxide sterilization
18.11.2016 - PDF - Englisch -
mehr dazu144,00 € -
AAMI/ISO 15675:2016
Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
18.11.2016 - PDF - Englisch -
mehr dazu125,00 € -
AAMI/ISO 7199:2016
Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
18.11.2016 - PDF - Englisch -
mehr dazu144,00 € -
AAMI/ISO 18242:2016
Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
18.11.2016 - PDF - Englisch -
mehr dazu144,00 € -
AAMI/IEC TIR80001-2-8:2016
Application of risk management for IT networks incorporating medical devices - Part 2-8: Application guidance Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
18.11.2016 - PDF - Englisch -
mehr dazu268,00 € -
AAMI/ISO 15676:2016
Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
18.11.2016 - PDF - Englisch -
mehr dazu144,00 € -
AAMI/ISO 22442-2:2016
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
17.11.2016 - PDF - Englisch -
mehr dazu144,00 € -
AAMI/ISO 22442-1:2016
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
17.11.2016 - PDF - Englisch -
mehr dazu190,00 € -
AAMI/ISO 15674:2016
Cardiovascular implants and artificial organs - Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
16.11.2016 - PDF - Englisch -
mehr dazu125,00 € -
AAMI/ISO 18241:2016
Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
07.11.2016 - PDF - Englisch -
mehr dazu179,00 € -
233,00 €
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AAMI/ISO TI(R1902)4:2016
Evaluation of CPB devices relative to their capabilities of reducing the transmition of gaseous microemboli (GME) to a patient during cardiopulmonary bypass
09.10.2016 - PDF - Englisch -
mehr dazu179,00 € -
AAMI/IEC TIR80002-3:2016
Technical Information Report Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
12.08.2016 - PDF - Englisch, Französisch -
mehr dazu220,00 € -
AAMI/ISO 16142-1:2016
Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
10.08.2016 - PDF - Englisch -
mehr dazu268,00 € -
AAMI TIR74:2016
Change summary for ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
09.08.2016 - PDF - Englisch -
mehr dazu144,00 € -
AAMI/ISO 80369-6:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
04.08.2016 - PDF - Englisch -
mehr dazu268,00 € -
AAMI/ISO 80369-5:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
04.08.2016 - PDF - Englisch -
mehr dazu220,00 € -
330,00 €
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AAMI/ISO 7198:2016
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
02.08.2016 - PDF - Englisch -
mehr dazu268,00 € -
AAMI/ISO 80369-3:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
05.06.2016 - PDF - Englisch -
mehr dazu268,00 € -
144,00 €
-
AAMI TIR35:2016 (R2021)
Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
04.06.2016 - PDF - Englisch -
mehr dazu220,00 € -
AAMI/IEC 62304:2006 & A1:2016
Medical device software - Software life cycle processes - Consolidated Text
07.04.2016 - PDF - Englisch -
mehr dazu268,00 € -
AAMI/IEC 62304:2006/A1:2016
Medical device software - Software life cycle processes, Amendment 1
07.04.2016 - PDF - Englisch -
mehr dazu223,00 € -
AAMI/ISO 13485:2016(R2019)
Medical devices - Quality management systems - Requirements for regulatory purposes
25.03.2016 - PDF - Englisch -
mehr dazu268,00 € -
Checklist for ISO 13485:2016, Medical Devices - Quality Management Systems- Requ
Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
01.03.2016 - PDF - Englisch -
mehr dazu353,00 € -
AAMI/IEC TIR60878:2015
Graphical Symbols for Electrical Equipment in Medical Practice
03.01.2016 - PDF - Englisch, Französisch -
mehr dazu480,00 € -
AAMI TIR65:2015
Sustainability of medical devices--Elements of a responsible product life cycle
01.01.2016 - PDF - Englisch -
mehr dazu251,00 € -
AAMI/ISO 12417-1:2015
Cardiovascular implants and extracorporeal systems - Vascular device-drugcombination products - Part 1: General requirements
15.11.2015 - PDF - Englisch -
mehr dazu221,00 € -
SEPT IEC 62304 Checklist:2015
IEC 62304:2015, Medical Device Software - Software Life Cycle Processes
20.10.2015 - PDF - Englisch -
mehr dazu353,00 € -
AAMI TIR48:2015 (R2021)
Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
14.08.2015 - PDF - Englisch -
mehr dazu179,00 € -
AAMI/IEC TIR80001-2-6:2014
Application of risk management for IT-networks incorporating medical - Application guidance - Part 2-6: Guidance for responsibility agreements
09.08.2015 - PDF - Englisch -
mehr dazu144,00 € -
AAMI/ISO 11135:2014
Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
27.07.2015 - PDF - Englisch -
mehr dazu310,00 € -
AAMI/ISO 80369-20:2015
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
30.03.2015 - PDF - Englisch -
mehr dazu251,00 € -
AAMI EQ89:2015 (R2023)
Guidance for the use of medical equipment maintenance strategies and procedures
06.02.2015 - PDF - Englisch -
mehr dazu153,00 € -
AAMI/IEC TIR80001-2-5:2014
Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
24.12.2014 - PDF - Englisch -
mehr dazu220,00 € -
AAMI/IEC TIR80001-2-7:2014
Application of risk management for IT-networks incorporating medical - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
24.12.2014 - PDF - Englisch -
mehr dazu310,00 € -
179,00 €
-
AAMI TIR63:2014(R2017) (R2023)
Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
23.12.2014 - PDF - Englisch -
mehr dazu153,00 € -
AAMI/ISO TIR37137:2014
Cardiovascular biological evaluation of medical device - Guidance for absorbable implants
28.11.2014 - PDF - Englisch -
mehr dazu144,00 € -
AAMI TIR62:2014(R2019)
Generating reports for the purpose of submitting defibrillation waveform data for evaluation
24.10.2014 - PDF - Englisch -
mehr dazu125,00 € -
AAMI TIR61:2014 (R2019)
Generating reports for human factors design validation results for external cardiac defibrillators
24.10.2014 - PDF - Englisch -
mehr dazu144,00 € -
144,00 €
-
144,00 €
-
AAMI/ISO 14708-1:2014
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
08.10.2014 - PDF - Englisch -
mehr dazu268,00 € -
AAMI/ISO 11140-1:2014
Sterilization of health care products - Chemical indicators - Part 1: General requirements
10.09.2014 - PDF - Englisch -
mehr dazu179,00 € -
AAMI/ISO 10993-3:2014
Biological evaluation of medical devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
14.08.2014 - PDF - Englisch -
mehr dazu144,00 € -
AAMI/ISO TI(R1677)5:2014
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
27.07.2014 - PDF - Englisch -
mehr dazu310,00 € -
AAMI/ISO 5841-2:2014
Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
21.07.2014 - PDF - Englisch -
mehr dazu168,00 € -
AAMI/ISO TI(R1766)5-3:2014/(R)2016
Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical product to a product family and processing category for steam sterilization
18.05.2014 - PDF - Englisch -
mehr dazu268,00 € -
AAMI/ISO TI(R1713)7:2014
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
04.05.2014 - PDF - Englisch -
mehr dazu173,00 € -
AAMI TIR52:2014(R2017) (R2023)
Environmental Monitoring For Terminally Sterilized Healthcare Products
10.03.2014 - PDF - Englisch -
mehr dazu134,00 € -
214,00 €
-
AAMI TIR37:2013
Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products.
30.12.2013 - PDF - Englisch -
mehr dazu144,00 € -
AAMI/ISO 11137-1:2006(R2015) & A1:2003 & A2:2019 (Consolidated Text)
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices, Includes A1:2013 & A2:2019
30.12.2013 - PDF - Englisch -
mehr dazu268,00 € -
AAMI TIR56:2013(R2016) (R2020)
Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
27.12.2013 - PDF - Englisch -
mehr dazu179,00 € -
AAMI ST79:2010/A4:2013 (R2014)
Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Amendment 4
14.10.2013 - PDF - Englisch -
mehr dazu102,00 € -
AAMI/ISO TI(R1300)4:2013/(R)2016
Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmaxSD
04.10.2013 - PDF - Englisch -
mehr dazu268,00 € -
140,00 €
-
AAMI/ISO TI(R1921)8-1:2011/A1:2013
Medical devices - Hierarchal coding structure for adverse events - Part 1: Event type codes, Amendment 1
01.08.2013 - PDF - Englisch -
mehr dazu71,00 € -
AAMI/ISO 5841-3:2013 (R2018)
Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
29.07.2013 - PDF - Englisch -
mehr dazu132,00 € -
AAMI/ISO 11137-2:2013(R2019)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
10.07.2013 - PDF - Englisch -
mehr dazu268,00 € -
AAMI/IEC TIR80001-2-4:2012
Application of risk management for IT-networks incorporating medical devices -- Part 2-4: General implementation guidance for healthcare delivery organizations
30.04.2013 - PDF - Englisch -
mehr dazu179,00 € -
220,00 €
-
AAMI/ISO 13408-1:2008(R2011)/A1:2013
Aseptic processing of health care products--Part 1: General requirements, Amendment 1
27.03.2013 - PDF - Englisch -
mehr dazu71,00 € -
AAMI TIR49:2013 (R2020)
Design of training and instructional materials for medical devices used in non-clinical environments
19.03.2013 - PDF - Englisch -
mehr dazu251,00 € -
AAMI EQ56:2013
Recommended practices for a medical equipment management program
13.03.2013 - PDF - Englisch -
mehr dazu220,00 € -
AAMI/ISO 13408-6:2005/A1:2013
Aseptic processing of health care products - Part 6: Isolator systems, Amendment 1
11.03.2013 - PDF - Englisch -
mehr dazu73,00 € -
AAMI ST77:2013 (R2018)
Containment devices for reusable medical device sterilization
01.02.2013 - PDF - Englisch -
mehr dazu179,00 € -
AAMI TIR29:2012(R2017)
Guide for process characterization and control in radiation sterilization of medical devices
31.12.2012 - PDF - Englisch -
mehr dazu251,00 € -
AAMI EC57:2012 (R2020)
Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms
18.12.2012 - PDF - Englisch -
mehr dazu220,00 € -
AAMI/ISO TI(R1921)8-2:2012
Medical devices -Hierarchical coding structure for adverse events - Part 2: Evaluation codes
10.12.2012 - PDF - Englisch -
mehr dazu132,00 € -
AAMI/ISO 25539-2:2012
Cardiovascular implants --Endovascular devices --Part 2: Vascular stents
03.12.2012 - PDF - Englisch -
mehr dazu310,00 € -
ANSI/AAMI ST15883-3:2012/(R)2015 (R2023)
Washer-disinfectors -Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006, MOD)
03.12.2012 - PDF - Englisch -
mehr dazu153,00 € -
ANSI/AAMI ST15883-2:2013/(R)2015 (R2023)
Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006, MOD)
03.12.2012 - PDF - Englisch -
mehr dazu153,00 € -
140,00 €
-
140,00 €
-
AAMI TIR44:2012
Non-invasive blood pressure motion artifact - Testing and evaluation of NIBP device performance in the presence of motion artifact
16.11.2012 - PDF - Englisch -
mehr dazu179,00 € -
AAMI/ISO 11658:2012
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
20.10.2012 - PDF - Englisch -
mehr dazu125,00 € -
AAMI/ISO 13408-7:2012(R2018)
Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products
27.09.2012 - PDF - Englisch -
mehr dazu179,00 € -
AAMI/IEC TIR80001-2-3:2012
Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
02.09.2012 - PDF - Englisch -
mehr dazu251,00 € -
AAMI/IEC TIR80001-2-1:2012
Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks, Practical applications and examples
02.09.2012 - PDF - Englisch -
mehr dazu268,00 € -
AAMI ST79:2010/A3:2012 (R2014)
Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Amendment 3
23.08.2012 - PDF - Englisch -
mehr dazu102,00 € -
AAMI TIR45:2012(R2018)
Guidance on the use of agile practices in the development of medical device software
20.08.2012 - PDF - Englisch -
mehr dazu268,00 € -
AAMI/IEC TIR80001-2-2:2012
Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security
20.08.2012 - PDF - Englisch -
mehr dazu268,00 € -
AAMI/ISO TI(R2381)0:2012/(R)2015
Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup
06.08.2012 - PDF - Englisch -
mehr dazu220,00 € -
AAMI/IEC 60601-2-47:2012 (R2016)
Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
01.08.2012 - PDF - Englisch -
mehr dazu268,00 € -
ANSI/AAMI/ISO 10993-12:2012
Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
26.07.2012 - PDF - Englisch -
mehr dazu179,00 € -
AAMI/ISO 25539-3:2011(R2015)
Cardiovascular implants - Endovascular devices - Part 3: Vena Cava Filters
05.06.2012 - PDF - Englisch -
mehr dazu310,00 € -
AAMI SW87:2012
Application of quality management system concepts to medical device data systems
23.05.2012 - PDF - Englisch -
mehr dazu158,00 € -
AAMI/ISO 13022:2012
Medical products containing viable human cells -- Application of risk management and requirements for processing practices
03.05.2012 - PDF - Englisch -
mehr dazu268,00 € -
AAMI/ISO 27185:2012(R2017)
Active implantable medical devices - Symbols to be used with cardiac device labels, labeling and information to be supplied by the manufacturer
13.01.2012 - PDF - Englisch -
mehr dazu268,00 €
