Medical Devices Web Portal
Includes


*The following is a sampling of the contents and not a complete listing.

AAMI
ANSI/AAMI/ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ANSI/AAMI/ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI/AAMI/ISO TIR11135-2:2008 Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1
ANSI/AAMI/ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI/AAMI/ISO 11137-2:2006 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ANSI/AAMI/ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
ANSI/AAMI/ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements
ANSI/AAMI/ISO 13408-2:2003 Aseptic processing of health care products - Part 2: Filtration
ANSI/AAMI/ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
ANSI/AAMI/ISO TIR14969:2004 Quality management systems - Medical devices - Guidance on the application of ISO 13485:2003
ANSI/AAMI/ISO 14971:2007 Medical devices - Application of risk management to medical devices
ANSI/AAMI/ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI/AAMI/ISO TIR17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1
ANSI/AAMI/IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
ANSI/AAMI/IEC 80601-2-58:2008 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery
ANSI/AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD)
ANSI/AAMI/IEC 62304:2006 Medical device software - Software life cycle processes
ANSI/AAMI EQ56:1999/(R)2008 Recommended practices for a medical equipment management program
ANSI/AAMI HE74:2001/(R)2009 Human factors design process for medical devices
ANSI/AAMI PB70:2003 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
ANSI/AAMI PC69:2007 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
ANSI/AAMI RD5:2003/(R)2008 Hemodialysis Systems
ANSI/AAMI RD16:2007 Cardiovascular Implants and Artificial Organs-Hemodialyzers‚ Hemodiafilters‚ Hemofilters‚ and Hemoconcentrators
ANSI/AAMI RD17:2007 Cardiovascular Implants and Artificial Organs-Extracorporeal Blood Circuit for Hemodialyzers‚ Hemodiafilters‚ and Hemofilters
ANSI/AAMI RD47:2008 Reprocessing of hemodialyzers
ANSI/AAMI RD52:2004 Dialysate for hemodialysis (Consolidated text with Amendments 1 through 4)
ANSI/AAMI RD61:2006 Concentrates for Hemodialysis
ANSI/AAMI RD62:2006 Water Treatment Equipment for Hemodialysis Applications
ANSI/AAMI ST41:2008 Ethylene oxide sterilization in health care facilities: Safety and effectiveness
ANSI/AAMI ST65:2008 Processing of reusable surgical textiles for use in health care facilities
ANSI/AAMI ST72:2002 Bacterial endotoxin -Test methodologies, routine monitoring and alternatives to batch testing
ANSI/AAMI ST79:2006 and A1:2008, A2:2009 Comprehensive guide to steam sterilization and sterility assurance in health care facilities (Consolidated text)
AAMI TIR12:2004 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
AAMI TIR14:2009 Contract sterilization using ethylene oxide
AAMI TIR17:2008 Compatibility of materials subject to sterilization
AAMI TIR28:2009 Product adoption and process equivalence for ethylene oxide sterilization
AAMI TIR32:2004 Medical device software risk management
AAMI TIR36:2007 Validation of software for regulated processes

IEC
IEC 60601-2-6: 1984 Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Microwave Therapy Equipment
IEC 61223-2-7:1999-09 Evaluation and Routine Testing in Medical Imaging Departments - Part 2-7: Constancy Tests - Equipment for Intra-Oral Dental Radiography Excluding Dental Panoramic Equipment
IEC 60601-2-10: 1987 Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Nerve and Muscle Stimulators
IEC 60601-2-16:1998-02 Medical Electrical Equipment - Part 2-16: Particular Requirements for the Safety of Haemodialysis‚ Haemodiafiltration and Haemofiltration Equipment
IEC 60601-2-46:1998 Medical Electrical Equipment - Part 2-46: Particular Requirements for the Safety of Operating Tables
IEC 61675-3:1998-02 Radionuclide Imaging Devices - Characteristics and Test Conditions - Part 3: Gamma Camera Based Wholebody Imaging Systems
IEC 61948-1:2001-02 Nuclear Medicine Instrumentation - Routine Tests - Part 1: Radiation Counting Systems
IEC 61948-2:2001-02 Nuclear Medicine Instrumentation - Routine Tests - Part 2: Scintillation Cameras and Single Photon Emission Computed Tomography Imaging
IEC 62054-21:2004-05 Electricity Metering (AC) - Tariff and Load Control - Part 21: Particular Requirements for Time Switches
IEC 62220-1:2003-10 Medical Electrical Equipment - Characteristics of Digital X-Ray Imaging Devices - Part 1: Determination of the Detective Quantum Efficiency

ISO
ISO 3575 Continuous Hot-Dip Zinc-Coated Carbon Steel Sheet of Commercial and Drawing Qualities
ISO 5834-5 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene - Part 5: Morphology Assessment Method
ISO 7197 Neurosurgical Implants - Sterile‚ Single-Use Hydrocephalus Shunts and Components
ISO 7376 Anaesthetic and Respiratory Equipment - Laryngoscopes for Tracheal Intubation
ISO 7867-2 Tyres and Rims (Metric Series) for Agricultural Tractors and Machines - Part 2: Service Description and Load Ratings
ISO 7886-3 Sterile Hypodermic Syringes for Single Use - Part 3: Auto-Disable Syringes for Fixed-Dose Immunization
ISO 8536-4 Infusion Equipment for Medical Use - Part 4: Infusion Sets for Single Use‚ Gravity Feed
ISO 8548-5 Prosthetics and Orthotics - Limb Deficiencies - Part 5: Description of the Clinical Condition of the Person Who Has Had an Amputation
ISO 8551 Prosthetics and Orthotics - Functional Deficiencies - Description of the Person to be Treated with an Orthosis‚ Clinical Objectives of Treatment‚ and Functional Requirements of the Orthosis
ISO 8871-5 Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use - Part 5: Functional Requirements and Testing
ISO 9342-1 Optics and Optical Instruments - Test Lenses for Calibration of Focimeters - Part 1: Test Lenses for Focimeters Used for Measuring Spectacle Lenses
ISO 9342-2 Optics and Optical Instruments - Test Lenses for Calibration of Focimeters - Part 2: Test Lenses for Focimeters Used for Measuring Contact Lenses
ISO 9927-3 Cranes - Inspections - Part 3: Tower Cranes
ISO 10322-1 Ophthalmic Optics - Semi-Finished Spectacle Lens Blanks - Part 1: Specifications for Single-Vision and Multifocal Lens Blanks
ISO 10322-2 Ophthalmic Optics - Semi-Finished Spectacle Lens Blanks - Part 2: Specifications for Progressive Power Lens Blanks
ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
ISO 10993-12 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
ISO 11418-1 Containers and Accessories for Pharmaceutical Preparations - Part 1: Drop-Dispensing Glass Bottles
ISO 11418-2 Containers and Accessories for Pharmaceutical Preparations - Part 2: Screw-Neck Glass Bottles for Syrups
ISO 11418-3 Containers and Accessories for Pharmaceutical Preparations - Part 3: Screw-Neck Glass Bottles (Veral) for Solid and Liquid Dosage Forms
ISO 11737-1 Sterilization of Medical Devices - Microbiological Methods - Part 1: Determination of a Population of Microorganisms on Products
ISO 11810-1 Lasers and Laser-Related Equipment - Test Method and Classification for the Laser Resistance of Surgical Drapes and/or Patient Protective Covers - Part 1: Primary Ignition and Penetration
ISO 11979-3 Ophthalmic Implants - Intraocular Lenses - Part 3: Mechanical Properties and Test Methods
ISO 11979-5 Ophthalmic Implants - Intraocular Lenses - Part 5: Biocompatibility
ISO 11979-7 Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations
ISO 11979-8 Ophthalmic Implants - Intraocular Lenses - Part 8: Fundamental Requirements
ISO/TR 14283 Implants for Surgery - Fundamental Principles
ISO 14408 Tracheal Tubes Designed for Laser Surgery - Requirements for Marking and Accompanying Information
ISO 14630 Non-Active Surgical Implants - General Requirements
ISO 15137 Self-Adhesive Hanging Devices for Infusion Bottles and Injection Vials - Requirements and Test Methods
ISO 15375 Hanging Devices for Multiple Use With Infusion Bottles - Requirements and Test Methods
ISO 15614-10 Specification and Qualification of Welding Procedures for Metallic Materials - Welding Procedure Test - Part 10: Hyperbaric Dry Welding
ISO/TR 16142 Medical Devices - Guidance on the Selection of Standards In Support of Recognized Essential Principles of Safety and Performance of Medical Devices
ISO/TS 20836 Microbiology of Food and Animal Feeding Stuffs - Polymerase Chain Reaction (PCR) for the Detection of Food-Borne Pathogens - Performance Testing for Thermal Cyclers
ISO 21649 Needle-Free Injectors for Medical Use - Requirements and Test Methods
ISO/TR 22520 Portable Hand-Held Forestry Machines - A-Weighted Emission Sound Pressure Levels at the Operator's Station - Comparative Data In 2002
ISO 23328-1 Breathing System Filters for Anaesthetic and Respiratory Use - Part 1: Salt Test Method to Assess Filtration Performance
ISO 23328-2 Breathing System Filters for Anaesthetic and Respiratory Use - Part 2: Non-Filtration Aspects
ISO/TS 24348 Ophthalmic Optics - Spectacle Frames - Method for the Simulation of Wear and Detection of Nickel Release From Coated Metal and Combination Spectacle Frames
ISO 25539-1 Cardiovascular Implants - Endovascular Devices - Part 1: Endovascular Prostheses
ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories

ASTM
Volume 13.01 Medical and Surgical Materials and Devices; Anesthetic and Respiratory Equipment; Pharmaceutical Application of Process Analytical Technology
Volume 13.02 Emergency Medical Services; Search and Rescue

DIN
EN 375 Information Supplied by the Manufacturer With In Vitro Diagnostic Reagents for Professional Use
EN 13612 Performance Evaluation of In Vitro Diagnostic Medical Devices