AAMI
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AAMI ST98:2022
Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
22/08/2022 - Papier - Anglais - AAMI
En savoir plus371,00 € -
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 - Anglais - AAMI
En savoir plus278,00 € -
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 - Papier - Anglais - AAMI
En savoir plus391,00 € -
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 - Anglais - AAMI
En savoir plus298,00 € -
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 - Papier - Anglais - AAMI
En savoir plus1 349,00 € -
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 - Anglais - AAMI
En savoir plus1 256,00 € -
AAMI/IEC 60601-1-2:2014 & A1:2021:2022
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests CONSOLIDATED EDITION
22/08/2022 - Papier - Anglais - AAMI
En savoir plus437,00 € -
AAMI/IEC 60601-1-2:2014 & A1:2021:2022
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests CONSOLIDATED EDITION
22/08/2022 - PDF - Anglais - AAMI
En savoir plus344,00 € -
AAMI/IEC 60601-1-8:2006 & A1:2013 & A2:2021:2022
MEDICAL ELECTRICAL EQUIPMENT - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems CONSOLIDATED EDITION
22/08/2022 - Papier - Anglais - AAMI
En savoir plus1 117,00 € -
AAMI/IEC 60601-1-8:2006 & A1:2013 & A2:2021:2022
MEDICAL ELECTRICAL EQUIPMENT - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems CONSOLIDATED EDITION
22/08/2022 - PDF - Anglais - AAMI
En savoir plus1 024,00 € -
AAMI ST44 : 2002
Resistometers used for characterizing the performance of biological and chemical indicators
10/07/2022 - PDF - Anglais - AAMI
En savoir plus92,00 € -
AAMI/ISO TIR 11137-4:2022
Sterilization of health care products-Radiation-Part 4: Guidance on process control
12/06/2022 - Papier - Anglais - AAMI
En savoir plus390,00 € -
AAMI/ISO TIR 11137-4:2022
Sterilization of health care products-Radiation-Part 4: Guidance on process control
12/06/2022 - PDF - Anglais - AAMI
En savoir plus297,00 € -
AAMI 2800-1-2:2022
Standard for Interoperable Item Development Life Cycle (ANSI/AAMI/UL 2800-1-2:2022)
10/06/2022 - Papier - Anglais - AAMI
En savoir plus371,00 € -
AAMI 2800-1-2:2022
Standard for Interoperable Item Development Life Cycle (ANSI/AAMI/UL 2800-1-2:2022)
10/06/2022 - PDF - Anglais - AAMI
En savoir plus278,00 € -
AAMI 2800-1:2022
Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2022)
10/06/2022 - Papier - Anglais - AAMI
En savoir plus437,00 € -
AAMI 2800-1:2022
Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2022)
10/06/2022 - PDF - Anglais - AAMI
En savoir plus344,00 € -
AAMI 2800-1-3:2022
Standard for Interoperable Item Integration Life Cycle (ANSI/AAMI/UL 2800-1-3:2022)
10/06/2022 - Papier - Anglais - AAMI
En savoir plus337,00 € -
AAMI 2800-1-3:2022
Standard for Interoperable Item Integration Life Cycle (ANSI/AAMI/UL 2800-1-3:2022)
10/06/2022 - PDF - Anglais - AAMI
En savoir plus244,00 € -
AAMI 2800-1-1:2022
Standard for Risk Concerns for Interoperable Medical Products (ANSI/AAMI/UL 2800-1-1:2022)
10/06/2022 - Papier - Anglais - AAMI
En savoir plus390,00 € -
AAMI 2800-1-1:2022
Standard for Risk Concerns for Interoperable Medical Products (ANSI/AAMI/UL 2800-1-1:2022)
10/06/2022 - PDF - Anglais - AAMI
En savoir plus297,00 € -
AAMI TIR100: 2021:2022
End-to-end microbiological quality and sterility assurance
10/05/2022 - Papier - Anglais - AAMI
En savoir plus262,00 € -
AAMI TIR100: 2021:2022
End-to-end microbiological quality and sterility assurance
10/05/2022 - PDF - Anglais - AAMI
En savoir plus198,00 € -
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 - Papier - Anglais - AAMI
En savoir plus371,00 € -
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 - Anglais - AAMI
En savoir plus278,00 € -
AAMI TIR104:2022
Guidance on transferring health care products between radiation sterilization sources
19/04/2022 - Papier - Anglais - AAMI
En savoir plus337,00 € -
AAMI TIR104:2022
Guidance on transferring health care products between radiation sterilization sources
19/04/2022 - PDF - Anglais - AAMI
En savoir plus244,00 € -
AAMI CR34971:2022
Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
01/04/2022 - Papier - Anglais - AAMI
En savoir plus337,00 € -
AAMI CR34971:2022
Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
01/04/2022 - PDF - Anglais - AAMI
En savoir plus244,00 € -
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 - Papier - Anglais - AAMI
En savoir plus199,00 € -
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 - Anglais - AAMI
En savoir plus135,00 € -
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 - Papier - Anglais - AAMI
En savoir plus381,00 € -
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 - Anglais - AAMI
En savoir plus288,00 € -
AAMI HIT1000-1: 2022:2022
Safety and effectiveness of health IT software and systems-Part 1: Fundamental concepts, principles, and requirements
01/03/2022 - Papier - Anglais - AAMI
En savoir plus371,00 € -
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 - Anglais - AAMI
En savoir plus278,00 € -
AAMI ST91:2021
Flexible and semi-rigid endoscope processing in health care facilities
21/12/2021 - Papier - Anglais - AAMI
En savoir plus495,00 € -
AAMI ST91:2021
Flexible and semi-rigid endoscope processing in health care facilities
21/12/2021 - PDF - Anglais - AAMI
En savoir plus401,00 € -
AAMI TIR 101:2021
Fluid delivery performance testing for infusion pumps
15/10/2021 - PDF - Anglais - AAMI
En savoir plus288,00 € -
AAMI CR510:2021
Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
24/09/2021 - PDF - Anglais - AAMI
En savoir plus135,00 € -
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 - Anglais - AAMI
En savoir plus324,00 € -
AAMI TIR42:2021
Evaluation of particulate associated with vascular medical devices
31/03/2021 - PDF - Anglais - AAMI
En savoir plus270,00 € -
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 - Anglais - AAMI
En savoir plus270,00 € -
AAMI TIR43:2021
Ultrapure dialysis fluid for hemodialysis and related therapies
26/02/2021 - PDF - Anglais - AAMI
En savoir plus270,00 € -
AAMI/ISO 14155:2020
Clinical investigation of medical devices for human subjects - Good clinical practice
07/12/2020 - PDF - Anglais - AAMI
En savoir plus334,00 € -
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 - Anglais - AAMI
En savoir plus155,00 € -
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 - Anglais - AAMI
En savoir plus155,00 € -
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 - Anglais - AAMI
En savoir plus288,00 € -
270,00 €
-
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 - Anglais - AAMI
En savoir plus237,00 € -
AAMI/IEC 80601-2-77:2020
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
03/08/2020 - PDF - Anglais - AAMI
En savoir plus279,00 € -
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 - Anglais - AAMI
En savoir plus288,00 € -
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 - Anglais - AAMI
En savoir plus25,00 € -
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 - Anglais - AAMI
En savoir plus288,00 € -
AAMI/ISO 8637-1:2017:2020
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
01/07/2020 - PDF - Anglais - AAMI
En savoir plus237,00 € -
AAMI/ISO 8637-3:2018:2020
Extracorporeal systems for blood purification - Part 3: Plasmafilters
01/07/2020 - PDF - Anglais - AAMI
En savoir plus192,00 € -
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 - Anglais - AAMI
En savoir plus192,00 € -
AAMI/ISO 10993-4:2017
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
27/04/2020 - PDF - Anglais - AAMI
En savoir plus288,00 € -
AAMI/ISO 10993-1:2018
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
27/04/2020 - PDF - Anglais - AAMI
En savoir plus288,00 € -
AAMI/ISO 10993-11:2017
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
27/04/2020 - PDF - Anglais - AAMI
En savoir plus237,00 € -
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 - Anglais - AAMI
En savoir plus270,00 € -
44,00 €
-
0,00 €
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AAMI/ISO TI (R2041)6:2020
Medical devices - Post-market surveillance for manufacturers
16/02/2020 - PDF - Anglais - AAMI
En savoir plus279,00 € -
AAMI/ISO TI (R2497)1:2020
Medical devices - Guidance on the application of ISO 14971
02/02/2020 - PDF - Anglais - AAMI
En savoir plus334,00 € -
381,00 €
-
288,00 €
-
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 - Papier - Anglais - AAMI
En savoir plus219,00 € -
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 - Anglais - AAMI
En savoir plus154,00 € -
AAMI/ISO 80369-1:2018
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
30/12/2019 - Papier - Anglais - AAMI
En savoir plus215,00 € -
AAMI/ISO 80369-1:2018
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
30/12/2019 - PDF - Anglais - AAMI
En savoir plus151,00 € -
AAMI/ISO 80369-3:2016/A1:2019
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment
30/12/2019 - PDF - Anglais - AAMI
En savoir plus151,00 € -
AAMI/ISO 23500-1:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements
23/12/2019 - Papier - Anglais - AAMI
En savoir plus427,00 € -
AAMI/ISO 23500-1:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements
23/12/2019 - PDF - Anglais - AAMI
En savoir plus334,00 € -
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 - Papier - Anglais - AAMI
En savoir plus256,00 € -
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 - Anglais - AAMI
En savoir plus192,00 € -
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 - Papier - Anglais - AAMI
En savoir plus256,00 € -
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 - Anglais - AAMI
En savoir plus192,00 € -
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 - Papier - Anglais - AAMI
En savoir plus314,00 € -
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 - Anglais - AAMI
En savoir plus237,00 € -
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 - Papier - Anglais - AAMI
En savoir plus363,00 € -
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 - Anglais - AAMI
En savoir plus270,00 € -
256,00 €
-
192,00 €
-
AAMI ST72:2019
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
01/11/2019 - Papier - Anglais - AAMI
En savoir plus381,00 € -
AAMI ST72:2019
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing, Includes Erratum (2020)
01/11/2019 - PDF - Anglais - AAMI
En savoir plus288,00 € -
AAMI/ISO 11138-7:2019
Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results
01/11/2019 - Papier - Anglais - AAMI
En savoir plus381,00 € -
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 - Anglais - AAMI
En savoir plus288,00 € -
AAMI TIR97:2019
Principles for medical device security - Postmarket risk management for device manufacturers
27/09/2019 - Papier - Anglais - AAMI
En savoir plus381,00 € -
AAMI TIR97:2019
Principles for medical device security - Postmarket risk management for device manufacturers
27/09/2019 - PDF - Anglais - AAMI
En savoir plus288,00 € -
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 - Papier - Anglais - AAMI
En savoir plus427,00 € -
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 - Anglais - AAMI
En savoir plus334,00 € -
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 - Papier - Anglais - AAMI
En savoir plus427,00 € -
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 - Anglais - AAMI
En savoir plus334,00 € -
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 - Papier - Anglais - AAMI
En savoir plus220,00 € -
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 - Anglais - AAMI
En savoir plus155,00 € -
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 - Papier - Anglais - AAMI
En savoir plus256,00 € -
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 - Anglais - AAMI
En savoir plus192,00 € -
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 - Papier - Anglais - AAMI
En savoir plus314,00 € -
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 - Anglais - AAMI
En savoir plus237,00 € -
AAMI TIR75:2019
Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
01/06/2019 - Papier - Anglais - AAMI
En savoir plus314,00 € -
AAMI TIR75:2019
Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
01/06/2019 - PDF - Anglais - AAMI
En savoir plus237,00 € -
AAMI/ISO 14971:2019
Medical devices - Application of risk management to medical devices
01/05/2019 - Papier - Anglais - AAMI
En savoir plus381,00 € -
AAMI/ISO 14971:2019
Medical devices - Application of risk management to medical devices
01/05/2019 - PDF - Anglais - AAMI
En savoir plus288,00 € -
AAMI/ISO 11137-1:2006 (R2015) A2:2019
A2:2019 to Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
01/05/2019 - PDF - Anglais - AAMI
En savoir plus128,00 € -
AAMI EQ93:2019
Medical equipment management - Vocabulary used in medical equipment programs
18/04/2019 - Papier - Anglais - AAMI
En savoir plus199,00 € -
AAMI EQ93:2019
Medical equipment management - Vocabulary used in medical equipment programs
18/04/2019 - PDF - Anglais - AAMI
En savoir plus135,00 € -
AAMI/ISO 81060-2:2019
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
22/03/2019 - Papier - Anglais - AAMI
En savoir plus363,00 € -
AAMI/ISO 81060-2:2019
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
22/03/2019 - PDF - Anglais - AAMI
En savoir plus270,00 € -
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 - Anglais - AAMI
En savoir plus334,00 € -
AAMI/IEC 80601-2-30:2018:2019
Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
30/01/2019 - PDF - Anglais - AAMI
En savoir plus279,00 € -
AAMI TIR38:2019
Medical device safety assurance case report guidance
25/01/2019 - Papier - Anglais - AAMI
En savoir plus381,00 € -
AAMI TIR38:2019
Medical device safety assurance case report guidance
25/01/2019 - PDF - Anglais - AAMI
En savoir plus288,00 € -
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 - Papier - Anglais - AAMI
En savoir plus256,00 € -
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 - Anglais - AAMI
En savoir plus192,00 € -
AAMI/ISO 11607-2: 2019
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
01/01/2019 - Papier - Anglais - AAMI
En savoir plus220,00 € -
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 - Anglais - AAMI
En savoir plus155,00 € -
381,00 €
-
288,00 €
-
AAMI HIT1000-1 (PS):2018
Safety and effectiveness of health IT software and systems - Part 1: Fundamental concepts, principles, and requirements
01/10/2018 - PDF - Anglais - AAMI
En savoir plus0,00 € -
AAMI TIR68:2018
Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
30/09/2018 - Papier - Anglais - AAMI
En savoir plus251,00 € -
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 - Anglais - AAMI
En savoir plus270,00 € -
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 - Anglais - AAMI
En savoir plus237,00 € -
AAMI/IEC 60601-2-21:2009 (R2014) & A1:2016
Medical Electrical Equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
01/09/2018 - PDF - Anglais - AAMI
En savoir plus230,00 € -
AAMI/IEC 60601-2-50:2009:2018 (R2014) & A1:2016
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
01/09/2018 - PDF - Anglais - AAMI
En savoir plus192,00 € -
AAMI/ISO TI(R2190)0:2018
Guidance for uncertainty analysis regarding the application of ISO/TS 10974
19/07/2018 - Papier - Anglais - AAMI
En savoir plus220,00 € -
AAMI/ISO TI(R2190)0:2018
Guidance for uncertainty analysis regarding the application of ISO/TS 10974
19/07/2018 - PDF - Anglais - AAMI
En savoir plus155,00 € -
AAMI TIR77:2018
Technical Information Report Sorbent-based regenerative hemodialysis systems
08/06/2018 - Papier - Anglais - AAMI
En savoir plus256,00 € -
AAMI TIR77:2018
Technical Information Report Sorbent-based regenerative hemodialysis systems
08/06/2018 - PDF - Anglais - AAMI
En savoir plus192,00 € -
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 - Papier - Anglais - AAMI
En savoir plus451,00 € -
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 - Anglais - AAMI
En savoir plus358,00 € -
AAMI TIR67:2018 (R2022)
Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
25/04/2018 - Papier - Anglais - AAMI
En savoir plus390,00 € -
AAMI TIR67:2018 (R2022)
Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
25/04/2018 - PDF - Anglais - AAMI
En savoir plus297,00 € -
AAMI TIR40:2018
Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
31/01/2018 - Papier - Anglais - AAMI
En savoir plus256,00 € -
AAMI TIR40:2018
Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
31/01/2018 - PDF - Anglais - AAMI
En savoir plus192,00 € -
AAMI/ISO 11737-1:2018
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
24/01/2018 - Papier - Anglais - AAMI
En savoir plus269,00 € -
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 - Anglais - AAMI
En savoir plus205,00 € -
256,00 €
-
AAMI TIR16:2017 (R2020)
Microbiological aspects of ethylene oxide sterilization
17/11/2017 - PDF - Anglais - AAMI
En savoir plus192,00 € -
AAMI/ISO 13408-2:2018
Aseptic processing of health care products - Part 2:Sterilizing filtration
17/11/2017 - Papier - Anglais - AAMI
En savoir plus220,00 € -
AAMI/ISO 13408-2:2018
Aseptic processing of health care products - Part 2:Sterilizing filtration
17/11/2017 - PDF - Anglais - AAMI
En savoir plus155,00 € -
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 - Papier - Anglais - AAMI
En savoir plus220,00 € -
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 - Anglais - AAMI
En savoir plus155,00 € -
AAMI ST79:2017
Comprehensive guide to steam sterilization and sterility assurance in health care facilities with Amendments A1:2020, A2:2020, A3:2020, A4:2020
01/10/2017 - Papier - Anglais - AAMI
En savoir plus576,00 € -
AAMI ST79:2017
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
with amendments A1:2020, A2:2020, A3:2020, A4:2020
01/10/2017 - PDF - Anglais - AAMI
En savoir plus483,00 € -
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 - Papier - Anglais - AAMI
En savoir plus381,00 € -
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 - Anglais - AAMI
En savoir plus288,00 € -
220,00 €
-
155,00 €
-
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 - Papier - Anglais - AAMI
En savoir plus251,00 € -
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 - Anglais - AAMI
En savoir plus186,00 € -
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 - Papier - Anglais - AAMI
En savoir plus314,00 € -
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 - Anglais - AAMI
En savoir plus237,00 € -
AAMI/ISO TIR80002-2:2017
Medical device software - Part 2: Validation of software for medical device quality systems
18/08/2017 - PDF - Anglais, Français - AAMI
En savoir plus334,00 € -
220,00 €
-
155,00 €
-
314,00 €
-
237,00 €
-
AAMI/ISO 11138-1:2017
Sterilization of health care products - Biological indicators - Part 1: General requirements
01/08/2017 - Papier - Anglais - AAMI
En savoir plus381,00 € -
AAMI/ISO 11138-1:2017
Sterilization of health care products - Biological indicators - Part 1: General requirements
01/08/2017 - PDF - Anglais - AAMI
En savoir plus288,00 € -
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 - Papier - Anglais - AAMI
En savoir plus199,00 € -
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 - Anglais - AAMI
En savoir plus135,00 € -
AAMI/ISO 11138-2:2017
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
01/08/2017 - Papier - Anglais - AAMI
En savoir plus199,00 € -
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 - Anglais - AAMI
En savoir plus135,00 € -
AAMI/ISO 11138-4:2017
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
01/08/2017 - Papier - Anglais - AAMI
En savoir plus199,00 € -
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 - Anglais - AAMI
En savoir plus135,00 € -
AAMI/ISO 11138-3:2017
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
01/08/2017 - Papier - Anglais - AAMI
En savoir plus199,00 € -
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 - Anglais - AAMI
En savoir plus135,00 € -
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 - Papier - Anglais - AAMI
En savoir plus381,00 € -
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 - Anglais - AAMI
En savoir plus288,00 € -
AAMI ST90:2017
Processing of health care products - Quality management systems for processing in health care facilities
18/07/2017 - Papier - Anglais - AAMI
En savoir plus363,00 € -
AAMI ST90:2017
Processing of health care products - Quality management systems for processing in health care facilities
18/07/2017 - PDF - Anglais - AAMI
En savoir plus270,00 € -
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 - Anglais - AAMI
En savoir plus288,00 € -
AAMI TIR17:2017
Compatibility of materials subject to sterilization
11/06/2017 - Papier - Anglais - AAMI
En savoir plus400,00 € -
AAMI TIR17:2017
Compatibility of materials subject to sterilization
11/06/2017 - PDF - Anglais - AAMI
En savoir plus307,00 € -
AAMI TIR21:2017 (R2020)
Systems Used to Forecast Remaining Pacemaker Battery Service Life
11/06/2017 - Papier - Anglais - AAMI
En savoir plus381,00 € -
AAMI TIR21:2017 (R2020)
Systems Used to Forecast Remaining Pacemaker Battery Service Life
11/06/2017 - PDF - Anglais - AAMI
En savoir plus288,00 € -
0,00 €
-
AAMI/ISO 25539-1:2017
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
25/05/2017 - Papier - Anglais - AAMI
En savoir plus314,00 € -
AAMI/ISO 25539-1:2017
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
25/05/2017 - PDF - Anglais - AAMI
En savoir plus237,00 € -
AAMI TIR69:2017 (R2020)
Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
28/04/2017 - Papier - Anglais - AAMI
En savoir plus381,00 € -
AAMI TIR69:2017 (R2020)
Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
28/04/2017 - PDF - Anglais - AAMI
En savoir plus288,00 € -
AAMI/ISO 14708-3:2017
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
02/03/2017 - Papier - Anglais - AAMI
En savoir plus363,00 € -
AAMI/ISO 14708-3:2017
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
02/03/2017 - PDF - Anglais - AAMI
En savoir plus270,00 € -
AAMI TIR66:2017 (R2020)
Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
28/02/2017 - Papier - Anglais - AAMI
En savoir plus314,00 € -
AAMI TIR66:2017 (R2020)
Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
28/02/2017 - PDF - Anglais - AAMI
En savoir plus237,00 € -
ANSI/AAMI/ISO 10993-6:2016
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
10/01/2017 - Papier - Anglais - AAMI
En savoir plus256,00 € -
ANSI/AAMI/ISO 10993-6:2016
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
10/01/2017 - PDF - Anglais - AAMI
En savoir plus192,00 € -
AAMI CI86:2017
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
06/01/2017 - Papier - Anglais - AAMI
En savoir plus427,00 € -
AAMI CI86:2017
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
06/01/2017 - PDF - Anglais - AAMI
En savoir plus334,00 € -
AAMI/ISO 15223-1:2016
Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
15/12/2016 - Papier - Anglais - AAMI
En savoir plus256,00 € -
AAMI/ISO 15223-1:2016
Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
15/12/2016 - PDF - Anglais - AAMI
En savoir plus192,00 € -
AAMI TIR15:2016 (R2020)
Physical aspects of ethylene oxide sterilization
18/11/2016 - Papier - Anglais - AAMI
En savoir plus256,00 € -
192,00 €
-
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 - Papier - Anglais - AAMI
En savoir plus381,00 € -
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 - Anglais - AAMI
En savoir plus288,00 € -
AAMI/ISO 7199:2016
Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
18/11/2016 - Papier - Anglais - AAMI
En savoir plus220,00 € -
AAMI/ISO 7199:2016
Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
18/11/2016 - PDF - Anglais - AAMI
En savoir plus155,00 € -
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 - Papier - Anglais - AAMI
En savoir plus220,00 € -
AAMI/ISO 15675:2016
Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
18/11/2016 - Papier - Anglais - AAMI
En savoir plus199,00 € -
AAMI/ISO 15675:2016
Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
18/11/2016 - PDF - Anglais - AAMI
En savoir plus135,00 €
