ISO 10993 - Biological Evaluation of Medical Devices Package
ISO 10993 - Medical Devices Complete Set, Parts 1 Thru 20 (Save 55% Of List Prices)
The ISO 10993 - Biological Evaluation of Medical Devices Package has an array of standards on testing, the identification / quantification of degradation products and other general biological evaluation of medical devices. The general biological evaluation of medical devices standards in this package include basic evaluation and testing, sterilization residuals, limits for leachable substances, and the preparation of samples / reference materials for testing. The referenced products are for the identification / quantification of degradation products are metals / alloys, ceramics and polymeric devices. These particular standards are supported by a toxicokinetic study design standard and framework standard for potential degradation products. The medical devices tests in this package are for system toxicity, hypersensitivity, local effects after implantation, genotoxicity, carcinogenicity, reproductive toxicity and interactions with blood.
This package is 55% off the individual list price and includes the following standards:
- ISO 10993-1:2018
- ISO 10993-2:2006
- ISO 10993-3:2014
- ISO 10993-4:2017
- ISO 10993-5:2009
- ISO 10993-6:2016
- ISO 10993-7:2008
- ISO 10993-7/Cor1:2009
- ISO 10993-9:2019
- ISO 10993-10:2010
- ISO 10993-11:2017
- ISO 10993-12:2012
- ISO 10993-13:2010
- ISO 10993-14:2001
- ISO 10993-15:2019
- ISO 10993-16:2017
- ISO 10993-17:2002
- ISO 10993-18:2020
- ISO/TS 10993-19:2020
- ISO/TS 10993-20:2006
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EN 980 / EN 1041 / EN ISO 14971 / EN ISO 13485 Medical Devices Package
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EN 980, EN 1041, EN ISO 14971, and EN ISO 13485 Medical Devices Package specifies the requirements for medical devices information supplied by a manufacturer along with symbols and labeling used in conjunction with that information. This package also provides the application of risk management and quality management systems in association with medical devices.
The EN 980, EN 1041, EN ISO 14971 and EN ISO 13485 Medical Devices Package includes:
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ISO 11138 - Sterilization of Health care Products Package
ISO 11138 - Sterilization Of Health Care Products Package - Parts 1 To 7
ISO 11138 - Sterilization of Health care Products Package provides methods for testing systems containing viable microorganisms providing a defined resistance to a specified sterilization process. The biological indicators sterilization processes supported in the ISO 11138 - Sterilization of Health care Products Package includes ethylene oxide, moist heat, dry heat, low-temperature steam, and formaldehyde.
This package includes the following standards:
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ISO 13485 / ISO 9001 - Medical Devices Quality Management Set
ISO 13485 And ISO 9001
The ISO 13485 / ISO 9001 - Medical Devices Quality Management Set specifies regulatory requirements for a medical device quality management system that can be used by organizations, suppliers and others involved in the various stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing, final decommissioning, and disposal of medical devices. ISO 13485 / ISO 9001 - Medical Devices Quality Management Set includes:
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ISO 15223 / ISO 10993-1 / ISO 11607 - Medical Devices Package
ISO 15223 / ISO 10993-1 / ISO 11607 - Medical Devices Package
ISO 15223 / ISO 10993-1 / ISO 11607 - Medical Devices Package provides the requirements necessary to protect terminally sterilized medical devices until the point of use.
ISO 15223 / ISO 10993-1 / ISO 11607 - Medical Devices also provides the requirements to be used for the development, selection, and validation of medical devices symbols. In addition, the package suggests the risk management process for terminally sterilized medical devices and the package includes:
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EN ISO 13485 / EN ISO 14971 - Risk and Quality Management Medical Devices Package
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ISO 10993-1 / ISO 10993-5 / ISO 10993-10 - Biological Evaluation of Medical Devices Package
ISO 10993-1 / ISO 10993-5 / ISO 10993-10 - Biological Evaluation of Medical Devices
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ISO 10993-1 / ISO 10993-5 / ISO 10993-10 - Biological Evaluation of Medical Devices Package includes:
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ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package
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ISO 11137 - Sterilization of Health Care Products Package
ISO 11137-1, ISO 11137-2 And ISO 11137-3
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This package includes the following ISO Standards:
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ISO 11737 - Sterilization of Medical Devices Package
ISO 11737 - Sterilization Of Medical Devices Package (Save 29% Off List Prices)
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The ISO 13485 and ISO 14971 - Medical Devices Package provides regulatory requirements for quality management medical device systems and incorporating and maintaining a risk management system associated with the use of medical devices. This package includes:
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ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package
ISO 13485 And ISO/TR 14969 Quality Management Systems Medical Devices Package
The ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package specifies the requirements and procedures to implement a quality management system for an organization that needs to consistently meet regulatory requirements applicable to medical devices and related services. The guidance standard ISO/TR 14969 provides approaches to establish objectives, implement, monitor and measure the processes to improve performance. The requirements and process approach are relevant to any regulated organization that designs and develops, produces, installs or services medical devices or provides related services. This package has a total savings of 30% off the list price and includes:
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ISO 21549 - Health Informatics Package
ISO 21549-1, ISO 21549-2, ISO 21549-3, ISO 21549-4, ISO 21549-5, ISO 21549-6, ISO 21549-7 And ISO 21549-8
The ISO 21549 - Health Informatics Package provides the platform for developing the structure of the patient health card data. The structure consists of device data, identification data, administrative data, clinical data, electronic prescription, security data and limited / extended clinical data. Additional standards are included that establish a common framework for the content / structure, architecture for electronic health records, physical characteristics of the health card and good principles and practices for a clinical data warehouse. This package contains the following documents:
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ISO 11607 - Terminally Sterilized Medical Devices Package
ISO 11607 - Terminally Sterilized Medical Devices Package.
The ISO 11607 - Terminally Sterilized Medical Devices Package provides the requirements and test methods for packaging intended to maintain the sterility of terminally sterilized medical devices until the point of use. It also provides the requirements for the development and validation of processes including forming, sealing, and assembly of packaging used for sterilized medical devices. This package includes ISO 11607-1:2019, ISO 11607-2:2019. It has been reduced 15% off of the individual list price.
ISO 11607 - Terminally Sterilized Medical Devices Package includes:
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- ISO 11607-2:2019
EN 62366 / EN ISO 14971 / EN 1041 / ISO 10993-1 - Medical Devices Package
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EN 62366 / EN ISO 14971 / EN 1041 / ISO 10993-1 - Medical Devices Package includes:
- EN 1041:2008+A1:2013
- EN 10993-1:2018
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ISO 18562 Evaluation of Breathing Gas Pathways Package
ISO 18562 - Evaluation Of Breathing Gas Pathways Package
Access guidelines and general principles to evaluate and test the biocompatibility of breathing gas pathways in healthcare applications. The ISO 18562 package is applicable to breathing gas medical devices such as ventilators, anesthesia workstations, breathing systems, oxygen conserving equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing system filters and Y-pieces as well as any breathing accessories intended to be used with such medical devices.
ISO 18562 - Evaluation of Breathing Gas Pathways Package includes:
- ISO 18562-1:2017
- ISO 18562-2:2017
- ISO 18562-3:2017
- ISO 18562-4:2017