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GOST 9533 - "Trowels, tuck pointing tools. Specifications"
January 22, 1981 - GOST
A description is not available for this item.
FDA Regulatory Affairs
February 28, 2014 - CRC

Preface This book is a roadmap to the U.S. Food and Drug Administration (FDA) and drug, biologic, and medical device development. The book is written in plain English, with an emphasis on easy access to understanding how this Agency operates with respect to the practical...

Handbook of Medical Device Design
September 14, 2000 - CRC

The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and...

21 CFR PART 821 - MEDICAL DEVICE TRACKING REQUIREMENTS
April 1, 2017 - FAA

(a) The regulations in this part implement section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act), which provides that the Food and Drug Administration may require a manufacturer to adopt a method of tracking a class II or class III device, if the device meets one of the...

ISO/IEEE FDIS 11073-10207 - Health informatics - Personal health device communication - Part 10207: Domain information and service model for service-oriented point-of-care medical device communication
August 24, 2018 - ISO

The scope of this standard is the definition and structuring of information that is communicated in a distributed system of point-of-care medical devices and medical information technology (IT) systems in which medical data needs to be exchanged or networked...

IEEE 11073-10207 - Health informatics - Point-of-care medical device communication - Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
December 6, 2017 - IEEE

The scope of this standard is the definition and structuring of information that is communicated in a distributed system of point-of-care medical devices and medical information technology (IT) systems in which medical data needs to be exchanged or networked...

IEEE P11073-10201 DRAFT - Health informatics - Point-of-care medical device communication - Part 10201: Domain information model
October 1, 2018 - IEEE

The scope of this project is to define a general object-oriented information model that may be used to structure information and identify services used in point-of-care medical device communications. The scope is primarily focused on acute care medical devices and...

DS/ISO/IEEE 11073-20702 - Health informatics – Point-of-care medical device communication – Part 20702: Medical devices communication profile for web services
September 3, 2018 - DS

Abstract: Within the context of the ISO/IEEE 11073 family of standards for point-of-care (PoC) medical device communication, a communication protocol specification for a distributed system of PoC medical devices and medical IT systems that need to exchange...

DI-TCSP-82040 - RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)
May 3, 2016 - NPFC

Use/relationship: This Data Item Description (DID) is published by the U.S Army Medical Research & Materiel Command (USAMRMC) to facilitate the acquisition of technical data to support the research and development of drugs, biologics, medical devices, or some component thereof...

IEEE P11073-20701 DRAFT - Draft Standard for Service-Oriented Medical Device Exchange Architecture and Protocol Binding
July 1, 2018 - IEEE

The scope of this standard is a service-oriented medical device architecture and communication protocol specification for distributed system of Point-of-Care (PoC) medical devices and medical IT systems that need to exchange data or safely control networked...

DSF/ISO/IEEE 11073-20702 - Health informatics – Point-of-care medical device communication – Part 20702: Medical devices communication profile for web services
DS

The scope of this standard is a communication protocol specification for a distributed system of point-of-care (PoC) medical devices and medical IT systems that need to exchange data or safely control networked PoC medical devices by defining a profile for...

DSF/ISO/IEEE 11073-10207 - Health informatics -- Personal health device communication -- Part 10207: Domain information and service model for service-oriented point-of-care medical device communication
DS

The scope of this standard is the definition and structuring of information that is communicated in a distributed system of point-of-care medical devices and medical information technology (IT) systems in which medical data needs to be exchanged or networked...

IEEE P11073-10101 DRAFT - Draft Standard for Health Informatics-Point-of-Care Medical Device Communication-Nomenclature
June 1, 2018 - IEEE

The scope of this standard is nomenclature architecture for point-of-care (POC) medical device communication (MDC). It consists of three parts: the body of the standard, which defines the overall architecture of the organization and relationships among nomenclature components;...

AAMI EQ93 - Medical equipment management - Vocabulary used in medical equipment programs
January 1, 2018 - AAMI

This standard provides consensus definitions for key terms used in medical equipment management around the maintenance, repair and servicing of medical devices, so that all stakeholders involved in the regulation, management and use of medical devices have common...

ISO/IEEE 11073-20702 - Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services
September 1, 2018 - ISO

The scope of this standard is a communication protocol specification for a distributed system of point-of-care (PoC) medical devices and medical IT systems that need to exchange data or safely control networked PoC medical devices by defining a profile for...

IEEE 11073-20702 - Health informatics - Point-of-care medical device communication - Part 20702: Medical Devices Communication Profile for Web Services
January 1, 2018 - IEEE

The scope of this standard is a communication protocol specification for a distributed system of point-of-care (PoC) medical devices and medical IT systems that need to exchange data or safely control networked PoC medical devices by defining a profile for...

CSA ISO 17664 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
January 1, 2018 - CSA

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective...

ISO 17664 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
October 1, 2017 - ISO

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective...

AAMI 17664 - Processing of health care products-Information to be provided by the medical device manufacturer for the processing of medical devices
January 1, 2017 - AAMI

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective...

ASQ H1426 - Quality Risk Management in the FDA-Regulated Industry
January 1, 2012 - ASQ

Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. The U.S. Food and Drug Administration (FDA) and its worldwide counterparts are...

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