Vocabulary Standard for IVD Products| In-Vitro Diagnostic | Medical Device | Series Lecture-3

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Vocabulary Standard for IVD Products| In-Vitro Diagnostic | Medical Device | Series Lecture-3
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In today 's lecture I will be covering the document by which vocabulary are decided for remaining standards .

Vocabulary-

Global Harmonization Task Force (GHTF)-
The document herein was produced by the Global Harmonization Task Force, a voluntary
group of representatives from medical device regulatory agencies and the regulated industry.
The document is intended to provide non-binding guidance for use in the regulation of medical
devices, and has been subject to consultation throughout its development
The purpose of this document is to publish a list of definitions used in all GHTF Final
Documents for use as a GHTF Glossary of Terms

IEC/VIM-
n general, a vocabulary is a “terminological dictionary which contains designations and definitions from one or more specific subject fields” (ISO 1087-1:2000, 3.7.2). The present Vocabulary pertains to metrology, the “science of measurement and its application”. It also covers the basic principles governing quantities and units. The field of quantities and units could be treated in many different ways.


Standard: A document, established by consensus and approved by a recognized body, that
provides, for common and repeated use, rules, guidelines or characteristics for
activities or their results, aimed at the achievement of the optimum degree of
order in a given context.

In vitro diagnostic (IVD)medical device: A medical device, whether used alone or in combination,
intended by the manufacturer for the in vitro examination of specimens derived
from the human body solely or principally to provide information for diagnostic,
monitoring or compatibility purposes

1. WHO,
2. Global Harmonization Task Force (GHTF)
3. International Medical Device Regulators Forum (IMDRF)
4. Asian Harmonization Working Party (AHWP)
5. International Organization for Standardization (ISO),
6. International Electrotechnical Commission (IEC), and
7. Clinical and Laboratory Standards Institute (CLSI).

List of Queries-
What is ISO Standards ?
What is ISO Standard for IVD Products?
What is ISO Standards for In-Vitro Diagnostic Products?
Standard for IV Products.
Standard for Medical Device Products
ISO 9000:2015 Quality management systems – Fundamentals and vocabulary
ISO 3534-1:2006 Statistics -- Vocabulary and symbols -- Part 1: General statistical terms and terms used in probability


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