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Standard [CURRENT] 2025
Human factors engineering-Design of medical devices
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Technical rule [CURRENT] 2025
Best practices for designing accessible at-home diagnostic test kits
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External transport of reusable medical devices for processing
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Cybersecurity considerations unique to machine learning–enabled medical devices
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Standard [CURRENT] 2024
Healthcare technology management (HTM) educational programs Corrigendum 1
Free of charge
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
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Healthcare technology management (HTM) educational programs
This document has been modified by: AAMI EQ110 Corrigendum 1:2024
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Chemical sterilization and high-level disinfection in health care facilities
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Technical rule [CURRENT] 2024
Microbiological methods - Understanding and use of product bioburden data
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
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Quality Management System (QMS) guidance on compliance with FDA's Final Rule on combination products
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General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing
Processing of dilators, transesophageal and ultrasound probes in health care facilities
Compatibility of materials subject to sterilization
Standard for a medical equipment management program
Alternate equipment management (AEM) program in healthcare delivery organizations (HDOs)
Technical rule [CURRENT] 2023
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
Standard [CURRENT] 2023
Aseptic processing of health care products - Part 1: General requirements
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems Amendment 1: Application of risk management
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management
Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation item for a biological indicator
Water for the processing of medical devices
Microbiological aspects of ethylene oxide sterilization
Application of ISO 14971 to machine learning in artificial intelligence - Guide
Guidance on the use of AGILE practices in the development of medical device software
Standard for medical device security - Security risk management for device manufacturers
Sterilization of health care products - Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
Technical rule [CURRENT] 2022
Sterilization of health care products - Radiation - Part 4: Guidance on process control
Standard [CURRENT] 2022
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
Sterilization of health care products - Biological and chemical indicators - Test equipment
Medical devices - Symbols to be used with information to be supplied by the manufacturer- Part 1: General requirements
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
Guidance on transferring health care products between radiation sterilization sources
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
Safety and effectiveness of health IT software and systems - Part 1: Fundamental concepts, principles, and requirements
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
Standard for Medical Device Interoperability
Standard for Risk Concerns for Interoperable Medical Products
Standard for Interoperable Item Development Life Cycle
Standard for Interoperable Item Integration Life Cycle
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
Sterilization of health care products - Microbiological methods - Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
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
Technical rule [CURRENT] 2021
Fluid delivery performance testing for infusion pumps
Standard [CURRENT] 2021
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, Amendment 2
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Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests, Amendment 1
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
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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
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, Amendment 2
Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
End-to-end microbiological quality and sterility assurance
Evaluation of particulate associated with vascular medical devices
Ultrapure dialysis fluid for hemodialysis and related therapies
Water testing methodologies
Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmax SD-S
General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
Active implantable medical devices- Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
Flexible and semi-rigid endoscope processing in health care facilities
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Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1
Medical devices - Information to be supplied by the manufacturer
Pre-standard 2020
Safety and effectiveness of health IT software and systems - Part 4: Application of human factors engineering
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Standard [CURRENT] 2020
Radiation therapy machine characterization
Technical rule [CURRENT] 2020
Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
Medical devices - Guidance on the application of ISO 14971
Medical devices - Post-market surveillance for manufacturers
Clinical investigation of medical devices for human subjects - Good clinical practice
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
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Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
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Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
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Medical devices - Part 1: Application of usability engineering to medical devices + Amendment 1
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Risk management guidance for combination products
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
Reprocessing of hemodialyzers
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
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Pre-standard 2019
Safety and effectiveness of health IT software and systems - Part 3: Application of risk management
Standard [CURRENT] 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
Non-invasive sphygmomanometers - Clinical investigation of intermittent automated measurement type
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements
Medical devices - Application of risk management to medical devices
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
This document has been modified by: AAMI/ISO 11607-2/A1:2023
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Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
This document has been modified by: AAMI/ISO 11607-1/A1:2023
Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
Technical rule [CURRENT] 2019
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
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Basic Introduction to the IEC 60601 Series
Medical device safety assurance case guidance
Principles for medical device security - Postmarket risk management for device manufacturers
Medical equipment management - Vocabulary used in medical equipment programs
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