Applicable Standard for IVD Product| Type of Standards available for IVD| Medical Device | Lecture-2

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Applicable Standard for IVD Product| Type of Standards available for IVD| Medical Device | Lecture-2
@ivdmanufacturing7208

In today 's lecture I will be covering the scope of IVD where Standards are applicable namely-

Vocabulary
IVD Design
Risk
Manufacturing
Quality Control
Pre Market Evaluation
Analytical Performance
Specimen Collection and Transport
Self Consideration and Testing
Stability
Robustness
Clinical Performance
Labelling
Post Market Surveillance
Changes

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
IEC 62366:2015 Medical devices—Part 1: Application of usability engineering to medical devices
IEC/TR 62366-2:2016Medical devices -- Part 2: Guidance on the application of usability engineering to medical devices
MM03-Ed3 Molecular Diagnostic Methods for Infectious Diseases, 3rd Edition
MM09-A2 Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline
POCT04-A2 Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline
EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
ISO 14971:2007 Medical Devices – Application of Risk Management to Medical Devices
ISO/TR 24971:2013 Medical devices -- Guidance on the application of ISO 14971
ISO 15198:2004 Clinical Laboratory Medicine - In Vitro Diagnostic Medical Devices - Validation of User Quality Control Procedures by the Manufacturer
EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
EN 61010-2-101:2002 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
ISO 13485:2016 Medical devices - Quality management systems -Requirements for regulatory purposes
ISO 9000:2015 Quality management systems – Fundamentals and vocabulary
21 CFR Part 820 Quality System Regulation
EN 13975:2003 Sampling Procedures Used for Acceptance Testing of In Vitro Diagnostic Medical Devices - Statistical Aspects
16142-2 Medical devices - Recognized essential principles of safety and performance of
medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
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#ISO9001
#MDR2017
#production
#diagnostics
#Audit
#medicaldevice
#QMS
#IVDMANUFACTURING
#adsivdmanufacturing
#manufacturingindustries

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