AAMI Normes américaines Normes

AAMI TIR109:2025

External transport of reusable medical devices for processing
01/01/2025 - PDF - Anglais - AAMI
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234,00 €

Sterilization of health care products—Chemical indicators—Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
01/01/2024 - PDF - Anglais - AAMI
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285,00 €

AAMI TIR106:2024

Microbiological methods—Understanding and use of product bioburden data
01/01/2024 - PDF - Anglais - AAMI
En savoir plus

234,00 €

AAMI TIR48:2024

Quality Management System (QMS) guidance on compliance with FDA's Final Rule on combination products
01/01/2024 - PDF - Anglais - AAMI
En savoir plus

267,00 €

AAMI TIR99:2024

Processing of dilators, transesophageal and ultrasound probes in health care facilities
01/01/2024 - PDF - Anglais - AAMI
En savoir plus

285,00 €

ANSI/AAMI ST24:2024

General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
01/01/2024 - PDF - Anglais - AAMI
En savoir plus

234,00 €

ANSI/AAMI ST58:2024

Chemical sterilization and high-level disinfection in health care facilities
01/01/2024 - PDF - Anglais - AAMI
En savoir plus

396,00 €

AAMI CR513:2024

Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing
01/01/2024 - PDF - Anglais - AAMI
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153,00 €

ANSI/AAMI EQ56:2024

Standard for a medical equipment management program
01/01/2024 - PDF - Anglais - AAMI
En savoir plus

267,00 €

ANSI/AAMI EQ103:2024

Alternate equipment management (AEM) program in healthcare delivery organizations (HDOs)
01/01/2024 - PDF - Anglais - AAMI
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234,00 €

ANSI/AAMI EQ110:2024

Healthcare technology management (HTM) educational programs
01/01/2024 - PDF - Anglais - AAMI
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153,00 €

AAMI TIR17:2024

Compatibility of materials subject to sterilization
01/01/2024 - PDF - Anglais - AAMI
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330,00 €

ANSI/AAMI/ISO 10993-13-2010/(R)2019:2023

Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices
01/01/2023 - PDF - Anglais - AAMI
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134,00 €

ANSI/AAMI SW96:2023

Standard for medical device security—Security risk management for device manufacturers
01/01/2023 - PDF - Anglais - AAMI
En savoir plus

285,00 €

AAMI TIR34971:2023

Application of ISO 14971 to machine learning in artificial intelligence—Guide
01/01/2023 - PDF - Anglais - AAMI
En savoir plus

234,00 €

AAMI TIR45:2023

Guidance on the use of AGILE practices in the development of medical device software
01/01/2023 - PDF - Anglais - AAMI
En savoir plus

330,00 €

AAMI TIR45:2023 Redline

Guidance on the use of AGILE practices in the development of medical device software
01/01/2023 - PDF - Anglais - AAMI
En savoir plus

330,00 €

ANSI/AAMI/ISO 11138-8:2023

Sterilization of health care products—Biological indicators—Part 8: Method for validation of a reduced incubation item for a biological indicator
01/01/2023 - PDF - Anglais - AAMI
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153,00 €

AAMI/ISO TIR16775:2023

Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2
01/01/2023 - PDF - Anglais - AAMI
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396,00 €

ANSI/AAMI ST108:2023

Water for the processing of medical devices
01/01/2023 - PDF - Anglais - AAMI
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330,00 €

AAMI/ISO TIR21387:2023

Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
01/01/2023 - PDF - Anglais - AAMI
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189,00 €

AAMI TIR16:2023

Microbiological aspects of ethylene oxide sterilization
01/01/2023 - PDF - Anglais - AAMI
En savoir plus

285,00 €

ANSI/AAMI/ISO 13408-1:2023

Aseptic processing of health care products—Part 1: General requirements
01/01/2023 - PDF - Anglais - AAMI
En savoir plus

330,00 €

ANSI/AAMI HIT1000-1:2022

Safety and effectiveness of health IT software and systems—Part 1: Fundamental concepts, principles, and requirements
01/01/2022 - PDF - Anglais - AAMI
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267,00 €

AAMI TIR104:2022

Guidance on transferring health care products between radiation sterilization sources
01/01/2022 - PDF - Anglais - AAMI
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234,00 €

ANSI/AAMI 2700-2-1:2022

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
01/01/2022 - PDF - Anglais - AAMI
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267,00 €

ANSI/AAMI/UL 2800-1-1:2022

Standard for Risk Concerns for Interoperable Medical Products
01/01/2022 - PDF - Anglais - AAMI
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285,00 €

ANSI/AAMI/UL 2800-1-2:2022

Standard for Interoperable Item Development Life Cycle
01/01/2022 - PDF - Anglais - AAMI
En savoir plus

267,00 €

ANSI/AAMI/UL 2800-1-3:2022

Standard for Interoperable Item Integration Life Cycle
01/01/2022 - PDF - Anglais - AAMI
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234,00 €

ANSI/AAMI/UL 2800-1:2022

Standard for Medical Device Interoperability
01/01/2022 - PDF - Anglais - AAMI
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330,00 €

ANSI/AAMI/ISO 18472:2022

Sterilization of health care products—Biological and chemical indicators—Test equipment
01/01/2022 - PDF - Anglais - AAMI
En savoir plus

267,00 €

ANSI/AAMI/ISO 5840-1:2022

Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements
01/01/2022 - PDF - Anglais - AAMI
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330,00 €

ANSI/AAMI/ISO 5840-2:2022

Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes
01/01/2022 - PDF - Anglais - AAMI
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285,00 €

ANSI/AAMI/ISO 5840-3:2022

Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques
01/01/2022 - PDF - Anglais - AAMI
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285,00 €

ANSI/AAMI/ISO 15223-1:2022

Medical devices—Symbols to be used with information to be supplied by the manufacturer— Part 1: General requirements
01/01/2022 - PDF - Anglais - AAMI
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267,00 €

AAMI/ISO TIR22456:2022

Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
01/01/2022 - PDF - Anglais - AAMI
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189,00 €

ANSI/AAMI PB70:2022 Redline

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
01/01/2022 - PDF - Anglais - AAMI
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285,00 €

ANSI/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
01/01/2022 - PDF - Anglais - AAMI
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234,00 €

ANSI/AAMI/ISO 17664-2:2022

Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices
01/01/2022 - PDF - Anglais - AAMI
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234,00 €

ANSI/AAMI ST98:2022

Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices
01/01/2022 - PDF - Anglais - AAMI
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267,00 €

AAMI/ISO TIR11137-4:2022/(R)2023

Sterilization of health care products—Radiation—Part 4: Guidance on process control
01/01/2022 - PDF - Anglais - AAMI
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285,00 €

ANSI/AAMI PB70:2022

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
01/01/2022 - PDF - Anglais - AAMI
En savoir plus

285,00 €

ANSI/AAMI/ISO 13004:2022

Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD
01/01/2022 - PDF - Anglais - AAMI
En savoir plus

285,00 €

AAMI CR510:2021

Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
01/01/2021 - PDF - Anglais - AAMI
En savoir plus

134,00 €

AAMI TIR101:2021

Fluid delivery performance testing for infusion pumps
01/01/2021 - PDF - Anglais - AAMI
En savoir plus

285,00 €

ANSI/AAMI CN27:2021

General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
01/01/2021 - PDF - Anglais - AAMI
En savoir plus

234,00 €

AAMI TIR58:2021/(R)2025

Water testing methodologies
01/01/2021 - PDF - Anglais - AAMI
En savoir plus

267,00 €

ANSI/AAMI ST91:2021

Flexible and semi-rigid endoscope processing in health care facilities
01/01/2021 - PDF - Anglais - AAMI
En savoir plus

385,00 €

AAMI TIR42:2021

Evaluation of particulate associated with vascular medical devices
01/01/2021 - PDF - Anglais - AAMI
En savoir plus

267,00 €

ANSI/AAMI PC76:2021

Active implantable medical devices— Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
01/01/2021 - PDF - Anglais - AAMI
En savoir plus

330,00 €

AAMI TIR43:2021/(R)2025

Ultrapure dialysis fluid for hemodialysis and related therapies
01/01/2021 - PDF - Anglais - AAMI
En savoir plus

267,00 €

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
01/01/2021 - PDF - Anglais - AAMI
En savoir plus

267,00 €

AAMI TIR100:2021

End-to-end microbiological quality and sterility assurance
01/01/2021 - PDF - Anglais - AAMI
En savoir plus

189,00 €

ANSI/AAMI/ISO 20417:2021

Medical devices—Information to be supplied by the manufacturer
01/01/2021 - PDF - Anglais - AAMI
En savoir plus

330,00 €

AAMI/ISO TIR20416:2020

Medical devices—Post-market surveillance for manufacturers
01/01/2020 - PDF - Anglais - AAMI
En savoir plus

267,00 €

AAMI/ISO TIR24971:2020

Medical devices—Guidance on the application of ISO 14971
01/01/2020 - PDF - Anglais - AAMI
En savoir plus

330,00 €

ANSI/AAMI RD47:2020

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

285,00 €

ANSI/AAMI MP80601-2-49:2020 (IEC 80601-2-49:2020, MOD)

Medical electrical equipment—Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
01/01/2020 - PDF - Anglais - AAMI
En savoir plus

267,00 €

AAMI HIT1000-4(PS):2020

Safety and effectiveness of health IT software and systems—Part 4: Application of human factors engineering
01/01/2020 - PDF - Anglais - AAMI
En savoir plus

23,00 €

AAMI TIR105:2020

Risk management guidance for combination products
01/01/2020 - PDF - Anglais - AAMI
En savoir plus

267,00 €

ANSI/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
01/01/2020 - PDF - Anglais - AAMI
En savoir plus

285,00 €

ANSI/AAMI/IEC 80601-2-78:2020

Medical electrical equipment—Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
01/01/2020 - PDF - Anglais - AAMI
En savoir plus

285,00 €

ANSI/AAMI/ISO 10993-16:2020/(R)2022

Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
01/01/2020 - PDF - Anglais - AAMI
En savoir plus

153,00 €

AAMI TIR12:2020/(R)2023

Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
01/01/2020 - PDF - Anglais - AAMI
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285,00 €

ANSI/AAMI/ISO 14155:2020

Clinical investigation of medical devices for human subjects—Good clinical practice
01/01/2020 - PDF - Anglais - AAMI
En savoir plus

330,00 €

AAMI/ISO TIR10993-19:2020

Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
01/01/2020 - PDF - Anglais - AAMI
En savoir plus

189,00 €

AAMI TIR97:2019/(R)2023

Principles for medical device security—Postmarket risk management for device manufacturers
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

285,00 €

AAMI HIT1000-3(PS):2019

Safety and effectiveness of health IT software and systems—Part 3: Application of risk management
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

23,00 €

AAMI TIR102:2019

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

330,00 €

AAMI TIR38:2019

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

285,00 €

AAMI TIR75:2019

Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

234,00 €

ANSI/AAMI EQ93:2019/(R)2025

Medical equipment management—Vocabulary used in medical equipment programs
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

134,00 €

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
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

234,00 €

ANSI/AAMI ST67:2019

Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled —sterile—
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

153,00 €

ANSI/AAMI ST72:2019

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

285,00 €

ANSI/AAMI/ISO 11138-7:2019

Sterilization of health care products—Biological indicators—Part 7: Guidance for the selection, use and interpretation of results
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

285,00 €

ANSI/AAMI/ISO 14117:2019/(R)2025

Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

330,00 €

ANSI/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

189,00 €

ANSI/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

153,00 €

ANSI/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
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

189,00 €

ANSI/AAMI/ISO 14971:2019

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

285,00 €

ANSI/AAMI/ISO 23500-1:2019

Preparation and quality management of fluids for haemodialysis and related therapies—Part 1: General requirements
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

330,00 €

ANSI/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
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

267,00 €

ANSI/AAMI/ISO 23500-3:2019

Preparation and quality management of fluids for haemodialysis and related therapies—Part 3: Water for haemodialysis and related therapies
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

189,00 €

ANSI/AAMI/ISO 23500-4:2019

Preparation and quality management of fluids for haemodialysis and related therapies—Part 4: Concentrates for haemodialysis and related therapies
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

234,00 €

ANSI/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
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

189,00 €

ANSI/AAMI/ISO 81060-2:2019

Non-invasive sphygmomanometers—Clinical investigation of intermittent automated measurement type
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

267,00 €

AAMI CR500:2019

Basic Introduction to the IEC 60601 Series
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

189,00 €

ANSI/AAMI/ISO 10993-15:2019

Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

153,00 €

AAMI/ISO/IEC Guide 63:2019

Guide to the development and inclusion of aspects of safety in International Standards for medical devices
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

227,00 €

ANSI/AAMI/ISO 11607-1:2019/A1:2023

Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems Amendment 1: Application of risk management
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

189,00 €

ANSI/AAMI/ISO 11607-2:2019/A1:2023

Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management
01/01/2019 - PDF - Anglais - AAMI
En savoir plus

153,00 €

AAMI TIR40:2018/(R)2022

Sterilization of health care products—Radiation—Guidance on dose setting utilizing a Modified Method 2
01/01/2018 - PDF - Anglais - AAMI
En savoir plus

189,00 €

AAMI TIR77:2018

Sorbent-based regenerative hemodialysis systems
01/01/2018 - PDF - Anglais - AAMI
En savoir plus

189,00 €

AAMI/ISO TIR10974:2018

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
01/01/2018 - PDF - Anglais - AAMI
En savoir plus

354,00 €

AAMI/ISO TIR21900:2018

Guidance for uncertainty analysis regarding the application of ISO/TS 10974
01/01/2018 - PDF - Anglais - AAMI
En savoir plus

153,00 €

ANSI/AAMI SW91:2018

Classification of defects in health software
01/01/2018 - PDF - Anglais - AAMI
En savoir plus

285,00 €

ANSI/AAMI/ISO 10993-1:2018

Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
01/01/2018 - PDF - Anglais - AAMI
En savoir plus

285,00 €

ANSI/AAMI/ISO 11737-1:2018

Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products
01/01/2018 - PDF - Anglais - AAMI
En savoir plus

285,00 €

ANSI/AAMI/ISO 13408-2:2018

Aseptic processing of health care products—Part 2: Sterilizing filtration
01/01/2018 - PDF - Anglais - AAMI
En savoir plus

153,00 €

ANSI/AAMI/ISO 80369-1:2018

Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements
01/01/2018 - PDF - Anglais - AAMI
En savoir plus

153,00 €

ANSI/AAMI/IEC 80601-2-30:2018

Medical electrical equipment—Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
01/01/2018 - PDF - Anglais - AAMI
En savoir plus

285,00 €

ANSI/AAMI/ISO 8637-3:2018

Extracorporeal systems for blood purification—Part 3: Plasmafilters
01/01/2018 - PDF - Anglais - AAMI
En savoir plus

189,00 €

ANSI/AAMI/ISO 8637-2:2018

Extracorporeal systems for blood purification— Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
01/01/2018 - PDF - Anglais - AAMI
En savoir plus

189,00 €

ANSI/AAMI/IEC 60601-2-16:2018

Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
01/01/2018 - PDF - Anglais - AAMI
En savoir plus

285,00 €

ANSI/AAMI/IEC 60601-2-39:2018

Medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
01/01/2018 - PDF - Anglais - AAMI
En savoir plus

234,00 €

AAMI TIR67:2018/(R)2022

Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
01/01/2018 - PDF - Anglais - AAMI
En savoir plus

285,00 €

AAMI TIR68:2018/(R)2022

Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
01/01/2018 - PDF - Anglais - AAMI
En savoir plus

234,00 €

ANSI/AAMI/ISO 11737-1:2018/A1:2021

Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products—AMENDMENT 1
01/01/2018 - PDF - Anglais - AAMI
En savoir plus

153,00 €

AAMI TIR21:2017/(R)2020

Systems used to forecast remaining pacemaker battery service life
01/01/2017 - PDF - Anglais - AAMI
En savoir plus

285,00 €

AAMI TIR69:2017/(R)2020

Risk management of radio-frequency wireless coexistence for medical devices and systems
01/01/2017 - PDF - Anglais - AAMI
En savoir plus

285,00 €

AAMI TIR72:2017

Dialysis fluid chemical composition
01/01/2017 - PDF - Anglais - AAMI
En savoir plus

153,00 €

ANSI/AAMI CI86:2017

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

330,00 €

AAMI/ISO TIR15499:2017

Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process
01/01/2017 - PDF - Anglais - AAMI
En savoir plus

189,00 €

AAMI/ISO TIR80002-2:2017

Medical device software—Part 2: Validation of software for medical device quality systems
01/01/2017 - PDF - Anglais - AAMI
En savoir plus

330,00 €

ANSI/AAMI ST90:2017/(R)2024

Processing of health care products—Quality management systems for processing in health care facilities
01/01/2017 - PDF - Anglais - AAMI
En savoir plus

267,00 €

ANSI/AAMI/ISO 10993-11:2017/(R)2023

Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
01/01/2017 - PDF - Anglais - AAMI
En savoir plus

234,00 €

ANSI/AAMI/IEC 60601-2-2:2017

Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
01/01/2017 - PDF - Anglais - AAMI
En savoir plus

285,00 €

ANSI/AAMI/ISO 10993-4:2017

Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
01/01/2017 - PDF - Anglais - AAMI
En savoir plus

285,00 €

ANSI/AAMI/ISO 11137-3:2017/(R)2023

Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine control
01/01/2017 - PDF - Anglais - AAMI
En savoir plus

153,00 €

ANSI/AAMI/ISO 11138-1:2017/(R)2024

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

285,00 €

ANSI/AAMI/ISO 11138-2:2017/(R)2024

Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes
01/01/2017 - PDF - Anglais - AAMI
En savoir plus

134,00 €

ANSI/AAMI/ISO 11138-3:2017/(R)2024

Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes
01/01/2017 - PDF - Anglais - AAMI
En savoir plus

134,00 €

ANSI/AAMI/ISO 11138-4:2017/(R)2024

Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes
01/01/2017 - PDF - Anglais - AAMI
En savoir plus

134,00 €

ANSI/AAMI/ISO 11138-5:2017/(R)2024

Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
01/01/2017 - PDF - Anglais - AAMI
En savoir plus

134,00 €

ANSI/AAMI/ISO 14708-3:2017

Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulators
01/01/2017 - PDF - Anglais - AAMI
En savoir plus

267,00 €

ANSI/AAMI/ISO 16142-2:2017 [HISTORICAL]

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
01/01/2017 - PDF - Anglais - AAMI
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285,00 €

ANSI/AAMI/ISO 25539-1:2017

Cardiovascular implants— Endovascular devices—Part 1: Endovascular prostheses
01/01/2017 - PDF - Anglais - AAMI
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234,00 €

AAMI TIR59:2017

Integrating human factors into design controls
01/01/2017 - PDF - Anglais - AAMI
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234,00 €

AAMI TIR66:2017/(R)2025

Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
01/01/2017 - PDF - Anglais - AAMI
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234,00 €

AAMI TIR71:2017/(R)2020

Guidance for logging of alarm system data
01/01/2017 - PDF - Anglais - AAMI
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153,00 €

ANSI/AAMI/ISO 8637-1:2017

Extracorporeal systems for blood purification—Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
01/01/2017 - PDF - Anglais - AAMI
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234,00 €

ANSI/AAMI ST79:2017/(R)2022 w/ AMDs A1:2020, A2:2020, A3:2020, A4:2020

Comprehensive guide to steam sterilization and sterility assurance in health care facilities
01/01/2017 - PDF - Anglais - AAMI
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478,00 €

AAMI TIR35:2016/(R)2021

Sterilization of health care products—Radiation sterilization—Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
01/01/2016 - PDF - Anglais - AAMI
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234,00 €

AAMI TIR57:2016/(R)2023

Principles for medical device security—Risk management
01/01/2016 - PDF - Anglais - AAMI
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330,00 €

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
01/01/2016 - PDF - Anglais - AAMI
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285,00 €

AAMI/IEC TIR80002-3:2016

Medical Device Software—Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
01/01/2016 - PDF - Anglais - AAMI
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234,00 €

ANSI/AAMI ST55:2016/(R)2023

Table-top steam sterilizers
01/01/2016 - PDF - Anglais - AAMI
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234,00 €

ANSI/AAMI/ISO 10993-6:2016

Biological evaluation of medical devices—Part 6: Tests for local effects after implantation
01/01/2016 - PDF - Anglais - AAMI
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189,00 €

ANSI/AAMI/ISO 13485:2016/(R)2019

Medical devices—Quality management systems—Requirements for regulatory purposes
01/01/2016 - PDF - Anglais - AAMI
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285,00 €

ANSI/AAMI/ISO 15674:2016

Cardiovascular implants and artificial organs—Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
01/01/2016 - PDF - Anglais - AAMI
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134,00 €

ANSI/AAMI/ISO 15675:2016

Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial blood line filters
01/01/2016 - PDF - Anglais - AAMI
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134,00 €

ANSI/AAMI/ISO 15676:2016

Cardiovascular implants and artificial organs—Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
01/01/2016 - PDF - Anglais - AAMI
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153,00 €

ANSI/AAMI/ISO 16142-1:2016 [HISTORICAL]

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
01/01/2016 - PDF - Anglais - AAMI
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285,00 €

ANSI/AAMI/ISO 18241:2016

Cardiovascular implants and extracorporeal systems—Cardiopulmonary bypass systems—Venous bubble traps
01/01/2016 - PDF - Anglais - AAMI
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189,00 €

ANSI/AAMI/ISO 18242:2016

Cardiovascular implants and extracorporeal systems—Centrifugal blood pumps
01/01/2016 - PDF - Anglais - AAMI
En savoir plus

153,00 €

ANSI/AAMI/ISO 22442-1:2016

Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management
01/01/2016 - PDF - Anglais - AAMI
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234,00 €

ANSI/AAMI/ISO 22442-2:2016

Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and handling
01/01/2016 - PDF - Anglais - AAMI
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153,00 €

ANSI/AAMI/ISO 80369-3:2016

Small-bore connectors for liquids and gases in healthcare applications—Part 3: connectors for enteral applications
01/01/2016 - PDF - Anglais - AAMI
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285,00 €

ANSI/AAMI/ISO 80369-3:2016/A1:2019

Small-bore connectors for liquids and gases in healthcare applications—Part 3: Connectors for enteral applications—Amendment 1
01/01/2016 - PDF - Anglais - AAMI
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153,00 €

ANSI/AAMI/ISO 80369-5:2016

Small-bore connectors for liquids and gases in healthcare applications—Part 5: Connectors for limb cuff inflation applications
01/01/2016 - PDF - Anglais - AAMI
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234,00 €

ANSI/AAMI/ISO 80369-6:2016

Small-bore connectors for liquids and gases in healthcare applications—Part 6: Connectors for neuraxial applications
01/01/2016 - PDF - Anglais - AAMI
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285,00 €

ANSI/AAMI/ISO 80369-7:2016

Small-bore connectors for liquids and gases in healthcare applications—Part 7: Connectors for intravascular or hypodermic applications
01/01/2016 - PDF - Anglais - AAMI
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285,00 €

ANSI/AAMI/ISO TIR19024:2016

Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass
01/01/2016 - PDF - Anglais - AAMI
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189,00 €

ANSI/AAMI/ISO 7198:2016

Cardiovascular implants—Tubular vascular prostheses
01/01/2016 - PDF - Anglais - AAMI
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285,00 €

ANSI/AAMI/ISO 7199:2016

Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators)
01/01/2016 - PDF - Anglais - AAMI
En savoir plus

153,00 €

AAMI/IEC TIR62366-2:2016

Medical devices—Part 2: Guidance on the application of usability engineering to medical devices
01/01/2016 - PDF - Anglais - AAMI
En savoir plus

330,00 €

ANSI/AAMI/IEC 60601-1-12:2016

Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment & medical electrical systems intended for use in emergency medical services environ.
01/01/2016 - PDF - Anglais - AAMI
En savoir plus

285,00 €

AAMI TIR14:2016/(R)2024

Contract sterilization using ethylene oxide
01/01/2016 - PDF - Anglais - AAMI
En savoir plus

153,00 €

AAMI TIR28:2016/(R)2024

Product adoption and process equivalence for ethylene oxide sterilization
01/01/2016 - PDF - Anglais - AAMI
En savoir plus

153,00 €

AAMI TIR15:2016/(R)2024

Physical aspects of ethylene oxide sterilization
01/01/2016 - PDF - Anglais - AAMI
En savoir plus

189,00 €

ANSI/AAMI/IEC 60601-1-12:2016/A1:2021

Medical electrical equipment—Part 1-12: General requirements—Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services environment—Amendment 1
01/01/2016 - PDF - Anglais - AAMI
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134,00 €

ANSI/AAMI/IEC 60601-1-12:2016 & A1:2021 Redline

Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance— Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services envi
01/01/2016 - PDF - Anglais - AAMI
En savoir plus

285,00 €

AAMI TIR65:2015/(R)2022

Sustainability of medical devices—Elements of a responsible product life cycle
01/01/2015 - PDF - Anglais - AAMI
En savoir plus

267,00 €

AAMI/IEC TIR60878:2015

Graphic symbols for electrical equipment in medical practice
01/01/2015 - PDF - Anglais - AAMI
En savoir plus

510,00 €

ANSI/AAMI EQ89:2015/(R)2023

Guidance for the use of medical equipment maintenance strategies and procedures
01/01/2015 - PDF - Anglais - AAMI
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153,00 €

ANSI/AAMI/ISO 80369-20:2015

Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
01/01/2015 - PDF - Anglais - AAMI
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267,00 €

ANSI/AAMI/IEC TIR62354:2015

General testing procedures for medical electrical equipment
01/01/2015 - PDF - Anglais - AAMI
En savoir plus

537,00 €

ANSI/AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD)

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.
01/01/2015 - PDF - Anglais - AAMI
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396,00 €

ANSI/AAMI/IEC 62366-1:2015/(R)2021+AMD1:2020 (Consolidated Text)

Medical devices—Part 1: Application of usability engineering to medical devices + Amendment 1
01/01/2015 - PDF - Anglais - AAMI
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285,00 €

ANSI/AAMI HA60601-1-11:2015/A1:2021

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, Amendment 1
01/01/2015 - PDF - Anglais - AAMI
En savoir plus

134,00 €

ANSI/AAMI HA60601-1-11:2015 & A1:2021 Redline

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
01/01/2015 - PDF - Anglais - AAMI
En savoir plus

396,00 €

AAMI TIR62:2014/(R)2019

Generating reports for the purpose of submitting defibrillation waveform data for evaluation
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

134,00 €

AAMI TIR52:2014/(R)2022

Environmental monitoring for terminally sterilized healthcare products
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

134,00 €

AAMI TIR55:2014/(R)2017

Human factors engineering for processing medical devices
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

189,00 €

AAMI/IEC TIR80001-2-5:2014

Application of risk management for IT-networks incorporating medical devices—Part 2-5: Application guidance—Guidance for distributed alarm systems
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

234,00 €

AAMI TIR60:2014/(R)2019

Common mode rejection in ECG monitoring
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

153,00 €

AAMI TIR61:2014/(R)2019

Generating reports for human factors design validation results for external cardiac defibrillator
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

153,00 €

AAMI/IEC TIR80001-2-7:2014

Application of risk management for IT-networks incorporating medical devices—Part 2-7: Application guidance—Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
01/01/2014 - PDF - Anglais - AAMI
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330,00 €

AAMI/ISO TIR17665-3:2014/(R)2016

Sterilization of health care products—Moist Heat—Guidance on the designation of a medical product to a product family and processing category for steam sterilization
01/01/2014 - PDF - Anglais - AAMI
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285,00 €

ANSI/AAMI/ISO 10993-3:2014/(R)2023

Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
01/01/2014 - PDF - Anglais - AAMI
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285,00 €

ANSI/AAMI/IEC 80601-2-58:2014

Medical electrical equipment—Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery
01/01/2014 - PDF - Anglais - AAMI
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189,00 €

ANSI/AAMI/IEC 80601-2-58:2014/A1:2016

Amendment 1 to Medical Electrical Equipment Part 2-58
01/01/2014 - PDF - Anglais - AAMI
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153,00 €

ANSI/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
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

330,00 €

ANSI/AAMI/ISO 11135:2014/A1:2018

Sterilization of health-care products— Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices—Amendment 1: Revision of Annex E, Single batch release
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

153,00 €

ANSI/AAMI/ISO 11140-1:2014

Sterilization of health care products—Chemical indicators—Part 1: General requirements
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

189,00 €

ANSI/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
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

285,00 €

ANSI/AAMI/ISO TIR37137:2014

Cardiovascular biological evaluation of medical devices—Guidance for absorbable implants
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

153,00 €

AAMI TIR50:2014/(R)2017

Post-market surveillance of use error management
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

234,00 €

AAMI TIR51:2014/(R)2017

Human factors engineering—Guidance for contextual inquiry
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

153,00 €

ANSI/AAMI/IEC 60601-1-2:2014

Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

396,00 €

AAMI/ISO TIR80001-2-6:2014

Application of risk management for IT-networks incorporating medical—Application guidance—Part 2-6: Guidance for responsibility agreements
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

153,00 €

AAMI TIR63:2014/(R)2023

Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

153,00 €

ANSI/AAMI/IEC 60601-1-2:2014/A1:2021

Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests, Amendment 1
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

267,00 €

ANSI/AAMI/IEC 60601-1-2:2014 & A1:2021 Redline

Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests Consolidated Text, Redline Version
01/01/2014 - PDF - Anglais - AAMI
En savoir plus

330,00 €

ANSI/AAMI NS4:2013/(R)2017

Transcutaneous electrical nerve stimulators
01/01/2013 - PDF - Anglais - AAMI
En savoir plus

153,00 €

ANSI/AAMI ST15883-2:2013/(R)2023 (ISO 15883-2:2006 MOD)

Washer-disinfectors—Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
01/01/2013 - PDF - Anglais - AAMI
En savoir plus

153,00 €