Matériel Médical / Medical equipment

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AAMI Standards and Recommended Practices

More than 200 national and international standards, recommended practices, technical information reports, and other resources covering sterilization, dialysis, biological evaluation of medical devices, quality systems, and medical equipment.

bulletALWAYS up to date

This is an annual subscription service. That means you are never out of touch with the technical documents you need. You'll get two CDs annually and around-the-clock access on the web for documents released between updates. We'll e-mail you every time a new document is available so you can download it instantly. That means no waiting, ever.

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AAMI Standards on CD is fully searchable so you can quickly locate the documents you need. Search by document name, title, or locate a specific term or phrase across the entire collection! Convenient links to give you more detailed information like in-depth descriptions and document history. And, every AAMI Standards on CD comes with a free Adobe Acrobat Reader.

ASTM VOL 13 - Medical Devices & Services

This section includes Volumes 13.01 and 13.02.

VOLUME 13.01


This volume provides the latest standards for:

Medical and Surgical Materials and Devices—standards address metals, polymers, and ceramics for implants; prostheses; medical and surgical devices; devices used in arthroplasty and osteosynthesis; silicone elastomers, gels, and foams in medical applications; and tissue engineered medical products. Each standard typically covers manufacture, chemical requirements, mechanical requirements, special tests, and certification. Accompanying the specifications are test methods, practices, guides, classifications, and terminology.

Anesthetic and Respiratory Equipment—specifications cover anesthesia machines and monitors, laryngoscopes, bronchoscopes, ventilators, and associated equipment.

Manufacture of Pharmaceutical Products—covers the application of process analytical technology (PAT) within the pharmaceutical industry, highlighting PAT system management, implementation, and practices.


VOLUME 13.02

Emergency Medical Services—covers emergency medical dispatch, ambulances, fixed wing basic and specialized units, and basic training for emergency medical technicians.

Search and Rescue—addresses search, rescue, and recovery operations, including the testing and maintenance of equipment, management and operations, and personnel training.

Anesthetic and Respiratory Equipment—specifications cover anesthesia machines and monitors, laryngoscopes, bronchoscopes, ventilators, and associated equipment.


Safety of Electromedical Devices

The book discusses the legal and technical requirements for manufacturers, designers and testers of electromedical devices. It describes which obstacles must be overcome to introduce a medical device on the European market, but also informs readers as to pitfalls and opportunities, and in which way safety can be achieved and product liability limited. It explains how the newly required risk management process, which comprises risk analysis, risk assessment, risk management and risk control, can be implemented. As a final essential consideration, the book describes which safety requirements are to be met and how they can be satisfied and tested.