AAMI Normes américaines Normes

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 plus

289,05 €

AAMI TIR42:2021

Evaluation of particulate associated with vascular medical devices
31/03/2021 - PDF - Anglais - AAMI
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240,88 €

AAMI/ISO 14155:2020

Clinical investigation of medical devices for human subjects - Good clinical practice
07/12/2020 - PDF - Anglais - AAMI
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289,05 €

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
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134,28 €

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
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134,28 €

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
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249,08 €

AAMI TIR105:2020

Risk management guidance for combination products
10/09/2020 - PDF - Anglais - AAMI
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233,70 €

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 plus

205,00 €

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 plus

249,08 €

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 plus

249,08 €

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 plus

21,53 €

AAMI/IEC 62366-1: 2015+AMD1:2020 (Consolidated Text)

Medical devices - Part 1: Application of usability engineering to medical devices, including Amendment 1
01/07/2020 - PDF - Anglais - AAMI
En savoir plus

249,08 €

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 plus

205,00 €

AAMI/ISO 8637-3:2018:2020

Extracorporeal systems for blood purification - Part 3: Plasmafilters
01/07/2020 - PDF - Anglais - AAMI
En savoir plus

166,05 €

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 plus

166,05 €

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 plus

249,08 €

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 plus

249,08 €

AAMI/ISO 10993-11:2017

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
27/04/2020 - PDF - Anglais - AAMI
En savoir plus

205,00 €

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
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233,70 €

AAMI RT3: 2020

Radiation therapy machine characterization
21/02/2020 - Papier - Anglais - AAMI
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39,52 €

AAMI RT3: 2020

Radiation therapy machine characterization
21/02/2020 - PDF - Anglais - AAMI
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0,00 €

AAMI/ISO TI (R2041)6:2020

Medical devices - Post-market surveillance for manufacturers
16/02/2020 - PDF - Anglais - AAMI
En savoir plus

249,08 €

AAMI/ISO TI (R2497)1:2020

Medical devices - Guidance on the application of ISO 14971
02/02/2020 - PDF - Anglais - AAMI
En savoir plus

289,05 €

AAMI RD47:2020

Reprocessing of hemodialyzers
23/01/2020 - Papier - Anglais - AAMI
En savoir plus

294,32 €

AAMI RD47:2020

Reprocessing of hemodialyzers
23/01/2020 - PDF - Anglais - AAMI
En savoir plus

249,08 €

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 plus

197,60 €

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 plus

137,35 €

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 plus

163,28 €

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 plus

134,28 €

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 plus

134,28 €

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 plus

334,88 €

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 plus

289,05 €

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 plus

195,52 €

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 plus

166,05 €

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 plus

195,52 €

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 plus

166,05 €

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 plus

235,04 €

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
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205,00 €

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 plus

264,16 €

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 plus

233,70 €

AAMI CR500:2019

Basic Introduction to the IEC 60601 Series
18/12/2019 - Papier - Anglais - AAMI
En savoir plus

195,52 €

AAMI CR500:2019

Basic Introduction to the IEC 60601 Series
18/12/2019 - PDF - Anglais - AAMI
En savoir plus

166,05 €

AAMI ST72:2019

Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
01/11/2019 - Papier - Anglais - AAMI
En savoir plus

294,32 €

AAMI ST72:2019

Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing, Includes Erratum (2020)
01/11/2019 - PDF - Anglais - AAMI
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249,08 €

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 plus

294,32 €

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 plus

249,08 €

AAMI TIR97:2019

Principles for medical device security - Postmarket risk management for device manufacturers
27/09/2019 - Papier - Anglais - AAMI
En savoir plus

294,32 €

AAMI TIR97:2019

Principles for medical device security - Postmarket risk management for device manufacturers
27/09/2019 - PDF - Anglais - AAMI
En savoir plus

249,08 €

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 plus

351,52 €

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 plus

289,05 €

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 plus

351,52 €

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 plus

289,05 €

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 plus

163,28 €

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 plus

134,28 €

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 plus

195,52 €

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
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166,05 €

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 plus

235,04 €

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 plus

205,00 €

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 plus

235,04 €

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 plus

205,00 €

AAMI/ISO 14971:2019

Medical devices - Application of risk management to medical devices
01/05/2019 - Papier - Anglais - AAMI
En savoir plus

279,76 €

AAMI/ISO 14971:2019

Medical devices - Application of risk management to medical devices
01/05/2019 - PDF - Anglais - AAMI
En savoir plus

249,08 €

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 plus

113,78 €

AAMI EQ93:2019

Medical equipment management - Vocabulary used in medical equipment programs
18/04/2019 - Papier - Anglais - AAMI
En savoir plus

145,60 €

AAMI EQ93:2019

Medical equipment management - Vocabulary used in medical equipment programs
18/04/2019 - PDF - Anglais - AAMI
En savoir plus

116,85 €

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 plus

264,16 €

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 plus

233,70 €

AAMI 2800-1:2019

Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2019)
25/02/2019 - Papier - Anglais - AAMI
En savoir plus

488,80 €

AAMI 2800-1:2019

Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2019)
25/02/2019 - PDF - Anglais - AAMI
En savoir plus

424,35 €

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 plus

289,05 €

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 plus

249,08 €

AAMI TIR38:2019

Medical device safety assurance case report guidance
25/01/2019 - Papier - Anglais - AAMI
En savoir plus

294,32 €

AAMI TIR38:2019

Medical device safety assurance case report guidance
25/01/2019 - PDF - Anglais - AAMI
En savoir plus

249,08 €

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 plus

210,08 €

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 plus

166,05 €

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 plus

163,28 €

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 plus

134,28 €

AAMI SW91:2018

Classification of defects in health software
02/11/2018 - Papier - Anglais - AAMI
En savoir plus

294,32 €

AAMI SW91:2018

Classification of defects in health software
02/11/2018 - PDF - Anglais - AAMI
En savoir plus

249,08 €

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 plus

0,00 €

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 plus

195,52 €

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 plus

233,70 €

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 plus

205,00 €

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 plus

205,00 €

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 plus

166,05 €

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 plus

163,28 €

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 plus

134,28 €

AAMI TIR77:2018

Technical Information Report Sorbent-based regenerative hemodialysis systems
08/06/2018 - Papier - Anglais - AAMI
En savoir plus

195,52 €

AAMI TIR77:2018

Technical Information Report Sorbent-based regenerative hemodialysis systems
08/06/2018 - PDF - Anglais - AAMI
En savoir plus

166,05 €

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 plus

372,32 €

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 plus

309,55 €

AAMI TIR67:2018

Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
25/04/2018 - Papier - Anglais - AAMI
En savoir plus

294,32 €

AAMI TIR67:2018

Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
25/04/2018 - PDF - Anglais - AAMI
En savoir plus

249,08 €

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 plus

195,52 €

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 plus

166,05 €

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 plus

221,52 €

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 plus

177,33 €

AAMI TIR16:2017

162
17/11/2017 - Papier - Anglais - AAMI
En savoir plus

195,52 €

AAMI TIR16:2017

Microbiological aspects of ethylene oxide sterilization
17/11/2017 - PDF - Anglais - AAMI
En savoir plus

171,18 €

AAMI/ISO 13408-2:2018

Aseptic processing of health care products - Part 2:Sterilizing filtration
17/11/2017 - Papier - Anglais - AAMI
En savoir plus

163,28 €

AAMI/ISO 13408-2:2018

Aseptic processing of health care products - Part 2:Sterilizing filtration
17/11/2017 - PDF - Anglais - AAMI
En savoir plus

134,28 €

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 plus

163,28 €

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 plus

134,28 €

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 plus

482,56 €

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 plus

418,20 €

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 plus

294,32 €

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 plus

249,08 €

AAMI TIR72:2017

Dialysis fluid chemical composition
08/09/2017 - Papier - Anglais - AAMI
En savoir plus

163,28 €

AAMI TIR72:2017

Dialysis fluid chemical composition
08/09/2017 - PDF - Anglais - AAMI
En savoir plus

134,28 €

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 plus

190,32 €

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 plus

160,93 €

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 plus

235,04 €

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 plus

205,00 €

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 plus

289,05 €

AAMI TIR71:2017 (R2020)

Guidance for logging of alarm system data
11/08/2017 - Papier - Anglais - AAMI
En savoir plus

163,28 €

AAMI TIR71:2017 (R2020)

Guidance for logging of alarm system data
11/08/2017 - PDF - Anglais - AAMI
En savoir plus

134,28 €

AAMI TIR59:2017

Integrating human factors into design controls
04/08/2017 - Papier - Anglais - AAMI
En savoir plus

235,04 €

AAMI TIR59:2017

Integrating human factors into design controls
04/08/2017 - PDF - Anglais - AAMI
En savoir plus

205,00 €

AAMI/ISO 11138-1:2017

Sterilization of health care products - Biological indicators - Part 1: General requirements
01/08/2017 - Papier - Anglais - AAMI
En savoir plus

294,32 €

AAMI/ISO 11138-1:2017

Sterilization of health care products - Biological indicators - Part 1: General requirements
01/08/2017 - PDF - Anglais - AAMI
En savoir plus

249,08 €

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 plus

145,60 €

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 plus

116,85 €

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 plus

145,60 €

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 plus

116,85 €

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 plus

145,60 €

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 plus

116,85 €

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 plus

145,60 €

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 plus

116,85 €

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
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294,32 €

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 plus

249,08 €

AAMI ST90:2017

Processing of health care products - Quality management systems for processing in health care facilities
18/07/2017 - Papier - Anglais - AAMI
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278,72 €

AAMI ST90:2017

Processing of health care products - Quality management systems for processing in health care facilities
18/07/2017 - PDF - Anglais - AAMI
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233,70 €

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 plus

249,08 €

AAMI TIR17:2017

Compatibility of materials subject to sterilization
11/06/2017 - Papier - Anglais - AAMI
En savoir plus

327,60 €

AAMI TIR17:2017

Compatibility of materials subject to sterilization
11/06/2017 - PDF - Anglais - AAMI
En savoir plus

265,48 €

AAMI TIR21:2017 (R2020)

Systems Used to Forecast Remaining Pacemaker Battery Service Life
11/06/2017 - Papier - Anglais - AAMI
En savoir plus

287,04 €

AAMI TIR21:2017 (R2020)

Systems Used to Forecast Remaining Pacemaker Battery Service Life
11/06/2017 - PDF - Anglais - AAMI
En savoir plus

241,90 €

AAMI RT2:2017

Radiation therapy readiness check
01/06/2017 - PDF - Anglais - AAMI
En savoir plus

0,00 €

AAMI/ISO 25539-1:2017

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
25/05/2017 - Papier - Anglais - AAMI
En savoir plus

266,24 €

AAMI/ISO 25539-1:2017

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
25/05/2017 - PDF - Anglais - AAMI
En savoir plus

205,00 €

AAMI TIR69:2017 (R2020)

Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
28/04/2017 - Papier - Anglais - AAMI
En savoir plus

294,32 €

AAMI TIR69:2017 (R2020)

Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
28/04/2017 - PDF - Anglais - AAMI
En savoir plus

256,25 €

AAMI/ISO 14708-3:2017

Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
02/03/2017 - Papier - Anglais - AAMI
En savoir plus

278,72 €

AAMI/ISO 14708-3:2017

Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
02/03/2017 - PDF - Anglais - AAMI
En savoir plus

233,70 €

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 plus

235,04 €

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 plus

205,00 €

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 plus

195,52 €

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 plus

166,05 €

AAMI CI86:2017

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
06/01/2017 - Papier - Anglais - AAMI
En savoir plus

351,52 €

AAMI CI86:2017

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
06/01/2017 - PDF - Anglais - AAMI
En savoir plus

289,05 €

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 plus

195,52 €

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 plus

166,05 €

AAMI TIR15:2016

Physical aspects of ethylene oxide sterilization
18/11/2016 - Papier - Anglais - AAMI
En savoir plus

195,52 €

AAMI TIR15:2016

Physical aspects of ethylene oxide sterilization
18/11/2016 - PDF - Anglais - AAMI
En savoir plus

171,18 €

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 plus

336,96 €

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 plus

249,08 €

AAMI/ISO 7199:2016

Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
18/11/2016 - Papier - Anglais - AAMI
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163,28 €

AAMI/ISO 7199:2016

Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
18/11/2016 - PDF - Anglais - AAMI
En savoir plus

134,28 €

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 plus

163,28 €

AAMI/ISO 15675:2016

Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
18/11/2016 - Papier - Anglais - AAMI
En savoir plus

145,60 €

AAMI/ISO 15675:2016

Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
18/11/2016 - PDF - Anglais - AAMI
En savoir plus

116,85 €

AAMI/ISO 18242:2016

Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
18/11/2016 - Papier - Anglais - AAMI
En savoir plus

163,28 €

AAMI/ISO 18242:2016

Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
18/11/2016 - PDF - Anglais - AAMI
En savoir plus

134,28 €

AAMI TIR28:2016

Product adoption and process equivalency for ethylene oxide sterilization
18/11/2016 - Papier - Anglais - AAMI
En savoir plus

163,28 €

AAMI TIR28:2016

Product adoption and process equivalency for ethylene oxide sterilization
18/11/2016 - PDF - Anglais - AAMI
En savoir plus

134,28 €

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 - Anglais - AAMI
En savoir plus

134,28 €

AAMI/ISO 22442-1:2016

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
17/11/2016 - Papier - Anglais - AAMI
En savoir plus

206,96 €

AAMI/ISO 22442-1:2016

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
17/11/2016 - PDF - Anglais - AAMI
En savoir plus

177,33 €

AAMI/ISO 22442-2:2016

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
17/11/2016 - Papier - Anglais - AAMI
En savoir plus

163,28 €

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 - Anglais - AAMI
En savoir plus

134,28 €

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 - Papier - Anglais - AAMI
En savoir plus

145,60 €

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 - Anglais - AAMI
En savoir plus

116,85 €

AAMI/ISO 18241:2016

Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
07/11/2016 - Papier - Anglais - AAMI
En savoir plus

195,52 €

AAMI/ISO 18241:2016

Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
07/11/2016 - PDF - Anglais - AAMI
En savoir plus

166,05 €

AAMI ST55:2016

Table-Top Steam Sterilizers
01/11/2016 - Papier - Anglais - AAMI
En savoir plus

235,04 €

AAMI ST55:2016

Table-Top Steam Sterilizers
01/11/2016 - PDF - Anglais - AAMI
En savoir plus

205,00 €

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 - Papier - Anglais - AAMI
En savoir plus

195,52 €

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 - Anglais - AAMI
En savoir plus

166,05 €

AAMI/IEC 60601-1-12:2016

Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performan - Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
06/10/2016 - PDF - Anglais - AAMI
En savoir plus

249,08 €

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 - Papier - Anglais, Français - AAMI
En savoir plus

277,68 €

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 - Anglais, Français - AAMI
En savoir plus

205,00 €

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 - Papier - Anglais - AAMI
En savoir plus

294,32 €

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 - Anglais - AAMI
En savoir plus

249,08 €

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 - Papier - Anglais - AAMI
En savoir plus

163,28 €

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 - Anglais - AAMI
En savoir plus

134,28 €