AAMI Normes américaines Normes

AAMI/ISO 11737-1:2018

AAMI/ISO CDV-3 11737-1, Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product
01/01/2018 - PDF sécurisé - Anglais - AAMI
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154,56 €

AAMI/ISO 13408-2:2018

Aseptic processing of health care products - Part 2: Sterilizing filtration
01/01/2018 - PDF sécurisé - Anglais - AAMI
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113,16 €

AAMI Standards online

AAMI Standards online
01/01/2018 - CD-Rom - Anglais - AAMI
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1 798,60 €

AAMI/ISO 14708-3:2017

Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
01/01/2017 - PDF sécurisé - Anglais - AAMI
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191,36 €

AAMI CI 86:2017

Cochlear implant systems - Safety, performance and reliability
01/01/2017 - PDF sécurisé - Anglais - AAMI
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237,36 €

AAMI/ISO 25539-1:2017

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
01/01/2017 - PDF sécurisé - Anglais - AAMI
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237,36 €

AAMI/ISO 10993-6:2017

Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
01/01/2017 - PDF sécurisé - Anglais - AAMI
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136,16 €

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 sécurisé - Anglais - AAMI
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237,36 €

AAMI ST 90:2017

Processing of health care products - Quality management systems for processing in health care facilities
01/01/2017 - PDF sécurisé - Anglais - AAMI
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191,36 €

AAMI ST 79:2017

Guide complet stérilisation à la vapeur et l'assurance de la stérilité dans les établissements de soins de santé
01/01/2017 - PDF sécurisé - Anglais - AAMI
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364,32 €

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
01/01/2017 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI/ISO 17664:2017

Sterilization of health care products - Information to be provided by the device manufacturer for the processing of medical devices
01/01/2017 - PDF sécurisé - Anglais - AAMI
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168,36 €

AAMI/ISO 11138-4:2017

Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
01/01/2017 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/ISO 11138-5:2017

Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
01/01/2017 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/ISO 11138-1:2017

Sterilization of health care products - Biological indicators - Part 1: General requirements
01/01/2017 - PDF sécurisé - Anglais - AAMI
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191,36 €

AAMI/ISO 11138-3:2017

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
01/01/2017 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/ISO 11138-2:2017

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
01/01/2017 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/ISO 11137-3:2017

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
01/01/2017 - PDF sécurisé - Anglais - AAMI
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168,36 €

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 sécurisé - Anglais - AAMI
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204,24 €

AAMI/IEC 62304 AMD 1:2016

Medical device software - Software life cycle processes, Amendment 1
01/01/2016 - PDF sécurisé - Anglais - AAMI
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191,36 €

AAMI/ISO 15223-2:2016

Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation
01/01/2016 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes
01/01/2016 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI/ISO 80369-5:2016

Small-bore connectors for liquids and gases in healthcare application - Part 5: Connectors for limb cuff inflation applications
01/01/2016 - PDF sécurisé - Anglais - AAMI
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168,36 €

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
01/01/2016 - PDF sécurisé - Anglais - AAMI
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204,24 €

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 and medical electrical systems intended for use in the emergency medical services environment
01/01/2016 - PDF sécurisé - Anglais - AAMI
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204,24 €

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 sécurisé - Anglais - AAMI
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204,24 €

AAMI/ISO 18242:2016

Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
01/01/2016 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/ISO 18241:2016

Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
01/01/2016 - PDF sécurisé - Anglais - AAMI
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136,16 €

AAMI/ISO 15674:2016

Cardiovascular implants and artificial organs - Hardshell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
01/01/2016 - PDF sécurisé - Anglais - AAMI
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95,68 €

AAMI/ISO 15675:2016

Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
01/01/2016 - PDF sécurisé - Anglais - AAMI
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95,68 €

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 sécurisé - Anglais - AAMI
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109,48 €

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 sécurisé - Anglais - AAMI
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109,48 €

AAMI/ISO 22442-1:2016

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
01/01/2016 - PDF sécurisé - Anglais - AAMI
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168,36 €

AAMI/IEC 60601-2-21/A1:2016

Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers, Amendment 1
01/01/2016 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/IEC 60601-2-20/A1:2016

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of transport infant incubators, Amendment 1
01/01/2016 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/ISO 7198:2016

Cardiovascular implants and extracorporeal systems - Vascular Prostheses - Tubular vascular grafts and vascular patches
01/01/2016 - PDF sécurisé - Anglais - AAMI
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204,24 €

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

Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery (Amendment 1)
01/01/2016 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/IEC 60601-2-50/A1:2016

Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment, Amendment 1
01/01/2016 - PDF sécurisé - Anglais - AAMI
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95,68 €

AAMI ST 55:2016

Table-top steam sterilizers
01/01/2016 - PDF sécurisé - Anglais - AAMI
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168,36 €

AAMI/ISO 7199:2016

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
01/01/2016 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/ISO 80369-7:2016

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
01/01/2016 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI/ISO 15223-1:2016 (R2017)

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
01/01/2016 - PDF sécurisé - Anglais - AAMI
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168,36 €

AAMI/IEC 80601-2-35/A1:2016

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses intended for heating in medical use, Amendment 1
01/01/2016 - PDF sécurisé - Anglais - AAMI
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95,68 €

AAMI/IEC 60601-2-19/A1:2016

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators, Amendment 1
01/01/2016 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI EQ 89:2015

Guidance for the use of medical equipment maintenance strategies and procedures
01/01/2015 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/IEC 62366-1:2015

Medical devices - Application of usability Engineering to medical devices
01/01/2015 - PDF sécurisé - Anglais - AAMI
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191,36 €

AAMI/ISO 80369-20:2015

Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
01/01/2015 - PDF sécurisé - Anglais - AAMI
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191,36 €

AAMI ST 91:2015

Flexible and semi-rigid endoscope reprocessing in health care facilities
01/01/2015 - PDF sécurisé - Anglais - AAMI
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204,24 €

ANSI/AAMI/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
01/01/2015 - PDF sécurisé - Anglais - AAMI
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252,08 €

AAMI HA 60601-1-11:2015

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 sécurisé - Anglais - AAMI
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285,20 €

AAMI/ISO 5840-2:2015

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
01/01/2015 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI/ISO 12417-1:2015

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
01/01/2015 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI/ISO 5840-1:2015

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
01/01/2015 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI/ISO 23747:2015

Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
01/01/2015 - PDF sécurisé - Anglais - AAMI
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126,96 €

AAMI/ISO 5367:2015

Anaesthetic and respiratory equipment - Breathing sets and connectors
01/01/2015 - PDF sécurisé - Anglais - AAMI
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191,36 €

AAMI/ISO 26782:2015

Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans
01/01/2015 - PDF sécurisé - Anglais - AAMI
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168,36 €

AAMI/ISO 8836:2015

Suction catheters for use in the respiratory tract
01/01/2015 - PDF sécurisé - Anglais - AAMI
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168,36 €

AAMI Standards - Dialysis (PDF Format)

The 2015 collection consists of 11 AAMI Hemodialysis standards, six of which were published in 2014
01/01/2015 - PDF sécurisé - Anglais - AAMI
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497,72 €

AAMI TIR34:2014

Water for the reprocessing of medical devices
08/04/2014 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI ST 15883-1/A1:2014

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests - Amendment 1
01/01/2014 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI/ISO 5841-2:2014

Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
01/01/2014 - PDF sécurisé - Anglais - AAMI
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136,16 €

AAMI 13958:2014

Concentrates for haemodialysis and related therapies
01/01/2014 - PDF sécurisé - Anglais - AAMI
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136,16 €

AAMI 11663:2014

Quality of dialysis fluid for haemodialysis and related therapies
01/01/2014 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI 13959:2014

Water for haemodialysis and related therapies
01/01/2014 - PDF sécurisé - Anglais - AAMI
En savoir plus

109,48 €

AAMI 26722:2014

Water treatment equipment for haemodialysis applications and related therapies
01/01/2014 - PDF sécurisé - Anglais - AAMI
En savoir plus

168,36 €

AAMI 23500:2014

Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
01/01/2014 - PDF sécurisé - Anglais - AAMI
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237,36 €

AAMI/ISO 11607-1 AMD 1:2014

Amendment 1 to ANSI/AAMI/ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging
01/01/2014 - PDF sécurisé - Anglais - AAMI
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58,88 €

AAMI/ISO 10993-3:2014

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
01/01/2014 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/ISO 11140-1:2014

Sterilization of health care products - Chemical indicators - Part 1: General requirements
01/01/2014 - PDF sécurisé - Anglais - AAMI
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136,16 €

AAMI/IEC 80601-2-58:2014

Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
01/01/2014 - PDF sécurisé - Anglais - AAMI
En savoir plus

136,16 €

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 sécurisé - Anglais - AAMI
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204,24 €

AAMI/ISO 11607-1/A1:2014 (R2016)

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging
01/01/2014 - PDF sécurisé - Anglais - AAMI
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55,20 €

AAMI/ISO 11607-2 AMD 1:2014 (R2016)

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
01/01/2014 - PDF sécurisé - Anglais - AAMI
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58,88 €

AAMI ST 15883-2:2013 (R2015)

Washer-disinfectors, Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc
01/01/2013 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI EQ 56:2013

Recommended practice for a medical equipment management program
01/01/2013 - PDF sécurisé - Anglais - AAMI
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168,36 €

AAMI/ISO 13408-1/A1:2013 (R2017)

Aseptic processing of health care products - Part 1: General requirements
01/01/2013 - PDF sécurisé - Anglais - AAMI
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58,88 €

AAMI/IEC 60601-1-8:2013

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
01/01/2013 - PDF sécurisé - Anglais - AAMI
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707,48 €

AAMI/IEC 80601-2-30/A1:2013 (R2017)

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated type non-invasive sphygmomanometers and Amendment 1
01/01/2013 - PDF sécurisé - Anglais - AAMI
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55,20 €

AAMI EC 53:2013

ECG trunk cables and patient leadwires
01/01/2013 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/ISO 11137-1 AMD 1:2013

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1
01/01/2013 - PDF sécurisé - Anglais - AAMI
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29,44 €

AAMI/ISO 13408-6/A1:2013

Aseptic processing of health care products - Part 6: Isolator systems - Amendment 1
01/01/2013 - PDF sécurisé - Anglais - AAMI
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58,88 €

AAMI ST 8:2013

Hospital steam sterilizers
01/01/2013 - PDF sécurisé - Anglais - AAMI
En savoir plus

168,36 €

AAMI/ISO 5841-3:2013

Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
01/01/2013 - PDF sécurisé - Anglais - AAMI
En savoir plus

109,48 €

AAMI ST 58:2013

Chemical sterilization and high-level disinfection in health care facilities
01/01/2013 - PDF sécurisé - Anglais - AAMI
En savoir plus

237,36 €

AAMI/ISO 11137-2:2013

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
01/01/2013 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI AT 6:2013

Autologous transfusion devices
01/01/2013 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/ISO 8637 AMD 1:2013 (R2015)

Cardiovascular Implants and Extracorporeal Systems - Hemodialyzers, Hemodiafilters, Hemofilters and Hemoconcentrators
01/01/2013 - PDF sécurisé - Anglais - AAMI
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58,88 €

AAMI NS 4:2013 (R2017)

Transcutaneous electrical stimulators
01/01/2013 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/ISO 27185:2012 (R2017)

Cardiac rhythm management devices - Symbols to be used with cardiac rhythm management device labels, and information to be supplied - General requirements
01/01/2012 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI/ISO 25539-3:2012 (R2015)

Cardiovascular Implants - Endovascular Devices - Part 3: Vena Cava Filters
01/01/2012 - PDF sécurisé - Anglais - AAMI
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223,56 €

AAMI PB 70:2012

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
01/01/2012 - PDF sécurisé - Anglais - AAMI
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136,16 €

AAMI/ISO 11658:2012

Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
01/01/2012 - PDF sécurisé - Anglais - AAMI
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95,68 €

AAMI/IEC 60601-2-47:2012 (R2017)

Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
01/01/2012 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI/ISO 10993-12:2012

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
01/01/2012 - PDF sécurisé - Anglais - AAMI
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136,16 €

AAMI ES 60601-1/Amendment 1:2012

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Amendment 1
01/01/2012 - PDF sécurisé - Anglais - AAMI
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223,56 €

AAMI/ISO 13408-7:2012

Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products
01/01/2012 - PDF sécurisé - Anglais - AAMI
En savoir plus

136,16 €

AAMI ST 15883-1/A2:2012

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests, Amendment 2
01/01/2012 - PDF sécurisé - Anglais - AAMI
En savoir plus

32,20 €

AAMI/IEC 60601-2-16:2012

Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
01/01/2012 - PDF sécurisé - Anglais - AAMI
En savoir plus

204,24 €

AAMI ST 15883-3:2012 (R2015)

Washer-disinfectors, Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
01/01/2012 - PDF sécurisé - Anglais - AAMI
En savoir plus

109,48 €

AAMI/ISO 5840-3:2012

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by minimally invasive techniques
01/01/2012 - PDF sécurisé - Anglais - AAMI
En savoir plus

237,36 €

AAMI EC 57:2012

Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms
01/01/2012 - PDF sécurisé - Anglais - AAMI
En savoir plus

168,36 €

AAMI BF 7:2012

Blood transfusion microfilters
01/01/2012 - PDF sécurisé - Anglais - AAMI
En savoir plus

109,48 €

AAMI/ISO 14117:2012

Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
01/01/2012 - PDF sécurisé - Anglais - AAMI
En savoir plus

237,36 €

AAMI BF 64:2012

Leukocyte reduction filters
01/01/2012 - PDF sécurisé - Anglais - AAMI
En savoir plus

109,48 €

AAMI/ISO 25539-2:2012

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
01/01/2012 - PDF sécurisé - Anglais - AAMI
En savoir plus

237,36 €

AAMI/ISO 13408-3:2012 (R2015)

Aseptic processing of health care products - Part 3: Lyophilization
01/01/2012 - PDF sécurisé - Anglais - AAMI
En savoir plus

109,48 €

AAMI/ISO 13408-5:2012 (R2015)

Aseptic processing of health care products - Part 5: Sterilization in place
01/01/2012 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/ISO 11140-4:2012 (R2015)

Sterilization Of Health Care Products - Chemical Indicators - Part 4: Class 2 Indicators As An Alternative To Bowie And Dick Test For Detection Of Steam Penetration
01/01/2012 - PDF sécurisé - Anglais - AAMI
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168,36 €

AAMI/ISO 11140-3:2012 (R2015)

Sterilization Of Health Care Products - Chemical Indicators - Part 3: Class 2 Indicator Systems For Use In The Bowie And Dick-Type Steam Penetration Test
01/01/2012 - PDF sécurisé - Anglais - AAMI
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168,36 €

AAMI/ISO 11140-5:2012 (R2015)

Sterilization of Health Care Products - Chemical Indicators - Part 5: Class 2 Indicators for Bowie and Dick Air Removal Test Sheets and Packs
01/01/2012 - PDF sécurisé - Anglais - AAMI
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136,16 €

AAMI/ISO 13022:2012

Medical products containing viable human cells -- Application of risk management and requirements for processing practices
01/01/2012 - PDF sécurisé - Anglais - AAMI
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223,56 €

AAMI TIR30:2011(R2016)

A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
08/10/2011 - PDF - Anglais - AAMI
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183,08 €

AAMI ST 67:2011 (R2017)

Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled 'sterile'
01/01/2011 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/IEC 60601-2-27:2011 (R2017)

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
01/01/2011 - PDF sécurisé - Anglais - AAMI
En savoir plus

204,24 €

AAMI/ISO 14160:2011 (R2016)

Sterilization of health care products--Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives--Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
01/01/2011 - PDF sécurisé - Anglais - AAMI
En savoir plus

191,36 €

AAMI/IEC 60601-2-25:2011 (R2017)

Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
01/01/2011 - PDF sécurisé - Anglais - AAMI
En savoir plus

285,20 €

AAMI ST 72:2011 (R2016)

Bacterial endotoxin - Test methods, routine monitoring and alternatives to batch testing
01/01/2011 - PDF sécurisé - Anglais - AAMI
En savoir plus

204,24 €

AAMI/IEC 80601-2-35:2011

Medical electrical equipment - Part 2-35: Particular requirements for basic safety and essential performance of blankets, pads and mattresses intended for heating in medical use, 2nd edition
01/01/2011 - PDF sécurisé - Anglais - AAMI
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95,68 €

AAMI TIR12:2010 Redline

Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
07/09/2010 - PDF - Anglais - AAMI
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218,04 €

AAMI/ISO 14708-5:2010 (R2015)

Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
01/01/2010 - PDF sécurisé - Anglais - AAMI
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192,28 €

AAMI/ISO 10993-10:2010 (R2014)

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
01/01/2010 - PDF sécurisé - Anglais - AAMI
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192,28 €

ANSI/AAMI/ ISO 8638:2010/(R)2015

Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
01/01/2010 - PDF sécurisé - Anglais - AAMI
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144,44 €

AAMI/IEC 80001-1:2010

Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
01/01/2010 - PDF sécurisé - Anglais - AAMI
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168,36 €

AAMI/IEC 60601-2-4:2010 (R2015)

Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
01/01/2010 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI/ISO 10993-13:2010 (R2014)

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
01/01/2010 - PDF sécurisé - Anglais - AAMI
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95,68 €

AAMI/ISO 14155:2010

Clinical investigation of medical devices for human subjects - Good clinical practice
01/01/2010 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI/ISO 20857:2010 (R2015)

Sterilization of health care products - Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices
01/01/2010 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI/ISO 27186:2010 (R2011)

Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
01/01/2010 - PDF sécurisé - Anglais - AAMI
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237,36 €

AAMI/ISO 18472:2010 (R2015)

Sterilization of Health Care Products - Biological and Chemical Indicators - Test Equipment
01/01/2010 - PDF sécurisé - Anglais - AAMI
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191,36 €

AAMI/ISO 80369-1:2010

Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
01/01/2010 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI EC 12:2010 (R2015)

Disposable ECG electrodes
01/01/2010 - PDF sécurisé - Anglais - AAMI
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136,16 €

AAMI/IEC 60601-2-19:2009 (R2014)

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
01/01/2009 - PDF sécurisé - Anglais - AAMI
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168,36 €

AAMI/IEC 60601-2-20:2009 (R2014)

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
01/01/2009 - PDF sécurisé - Anglais - AAMI
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168,36 €

AAMI/IEC 60601-2-50:2009 (R2014)

Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
01/01/2009 - PDF sécurisé - Anglais - AAMI
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136,16 €

AAMI/ISO 10993-5:2009 (R2014)

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
01/01/2009 - PDF sécurisé - Anglais - AAMI
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136,16 €

AAMI/IEC 80601-2-30:2009

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
01/01/2009 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI/ISO 10993-1:2009 (R2013)

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
01/01/2009 - PDF sécurisé - Anglais - AAMI
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136,16 €

AAMI/ISO 11737-2:2009 (R2014)

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
01/01/2009 - PDF sécurisé - Anglais - AAMI
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109,48 €

AAMI/IEC 80601-2-30/C1:2009

Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
01/01/2009 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI/ISO 14161:2009 (R2014)

Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
01/01/2009 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI ES 60601-1 C 1 and A2:2009 (R2012)

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
01/01/2009 - PDF sécurisé - Anglais - AAMI
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895,16 €

AAMI ST 15883-1:2009 (R2014)

Washer-disinfectors, Part 1: General requirements, terms and definitions and tests
01/01/2009 - PDF sécurisé - Anglais - AAMI
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204,24 €

AAMI/ISO 14937:2009 (R2013)

Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
01/01/2009 - PDF sécurisé - Anglais - AAMI
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175,72 €