ANSI/AAMI/ISO
13408 - Aseptic Processing of Health Care Products Package
The
ANSI/AAMI/ISO 13408 - Aseptic Processing of Health Care Products Package
provides guidance and the requirements on processes, programs and procedures to
develop, validate and control the manufacturing process of a
aseptically-processed health care products. An alternative to terminal
sterilization, aseptic processing enables the sterility of pre-sterilized
components and products during assembly allowing the final product to be sterile
in its final container (resulting in an terminally sterilized product). In
addition to the general requirement, the ANSI/AAMI/ISO 13408 - Aseptic
Processing of Health Care Products Package provides the various processes to
attain a terminally sterilized product.
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Price: $346.00
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ANSI/AAMI/ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects Package
The ANSI/AAMI/ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects Package defines procedures and requirements for the conduct and performance of clinical investigations of medical devices under normal clinical use. This package aims to protect human subjects, ensure the scientific conduct of the clinical investigation and assist monitors, investigators, ethic committees and all bodies involved in the conformity assessment of medical devices.
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Price: $$150.00
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DIN EN 980 and DIN EN 1041 Medical Devices Package (Foreign Standard)
The DIN EN 980 and DIN EN 1041 Medical Devices Package specifies the guidelines and requirements for information that is to be supplied by a manufacturer of medical devices regulated by Council Directive 90/385/EEC and Council Directive 93/42/EEC. It also provides symbols for use in the information supplied by the manufacturer of medical devices. The DIN EN 980 and DIN EN 1041 Medical Devices Package enables conformity of manufacturers' informational requirements and symbols for medical devices.
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Price: $423.00
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ISO 13485 /
14971 / 14969 - Medical Devices Package
The ISO 13485 / 14971 / 14969 - 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. |
Price: $397.00
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ISO 11135 -
Sterilization of Health Care Products Package
ISO 11135 - Sterilization of Health Care Products Package specifies the
requirements for the development, validation and routine control of ethylene
oxide sterilization process for medical devices and other healthcare products. |
Price: $207.00
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ANSI/AIHA Z88. Respirator Package
ANSI/AIHA Z88. Respirator Package provides guidance for medical professional to determine the qualifications to administer the use of respirators
on patients under the respiratory protection program. The ANSI/AIHA Z88. Respirator Package also provides guidance for training individuals on conducting
respirator fit testing and air purifying respirator components.
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Price: $147.00
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ISO 13485 and
ISO 14971 - Medical Devices Package
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.
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Price: $297.00
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ISO 21549 - Health Informatics Package
The ISO 21549 - Health Informatics Package provides the platform for developing the structure of the patient healthcard data. The structure consists of device data, identification data, administrative data, clinical data, electronic prescription, security data and limited / extended clinical data.
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Price: $262.00
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ISO 11737 - Sterilization of Medical Devices Package
The ISO 11737 - Sterilization of Medical Devices Package provides the requirements to estimate and determine the population of viable microorganisms on a product and to test the sterility of a product that has been treated with a sterilizing agent. The determination of bioburden can be used to validate the sterilization process, monitor the manufacturing processes and assess the overall environmental monitoring programme.
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Price: $156.00
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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.
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Price: $157.00
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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.
Total savings of 30% off the individual list price.
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Price: $252.00
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ISO 11137 - Sterilization of Health Care Products Package
The ISO 11137 - Sterilization of Health Care Products Package provides the requirements for developing, validating and routinely controlling the
sterilization process of medical devices
Total savings of 25% off the individual list price.
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Price: $236.00
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ISO 10993 - Biological Evaluation of Medical Devices Package
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 complete with the entire collection of ISO 10993 standards.
Total savings of 33% off the individual list price.
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Price: 983.00
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Biological Evaluation
of Medical Devices Standards Package
More than 15 standards have been complied to create the Biological Evaluation of Medical Devices package. For your convenience it includes animal welfare requirements,
ethylene oxide sterilization, identification and quantification of potential degradation products, limits for leachable substances, clinical investigation plans
and medical devices for human subjects.
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Price: $495.00
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Cardiovascular Medical Device Package
This Cardiovascular Medical Device Package includes the safety, monitoring and performance requirements for the more frequently used cardio medical devices.
The package consists of standards that envelope cardiac monitors, sphygmomanometers, electrocardiographs, ECG cables / lead wires / electrodes,
blood pressure transducers and defibrillator devices. This 13 standard Cardiovascular Medical Device package is essential.
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Price: $954.00
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Health Informatics - Patient Healthcard Data Package
The Health Informatics - Patient Healthcard Data Package provides the platform for developing the structure of the patient healthcard 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 healthcard and good principles and practices for a clinical data warehouse.
Total Savings: 20% of individual purchase price.
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Price: $414.00
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ISO 594 - Conical Fittings Package
The ISO 594 - Conical Fittings Package specifies the requirements for conical lock fittings with a 6% taper. It covers conical fittings made of rigid and semi-rigid materials to be used with hypodermic needles and syringes. Test methods for gauging and performance are also included.
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Price: $121.00
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