ENV 5613 Instructor: Dr. Berrin Tansel Presented by: Puneet Gill & Waseem Haider

Meaning of word standard something considered by an authority or by general consent as a basis of comparison an approved model an object that is regarded as the usual or most common size or form of its kind a rule or principle that is used as a basis for judgment an average or normal requirement, quality, quantity, level, grade, etc

What are standards? Standard is a published specification that establishes a common language, and contains a technical specification or other precise criteria and is designed to be used consistently, as a rule, a guideline, or a definition. Standards are applied to many materials, products, methods and services. They help to make life simpler, and increase the reliability and the effectiveness of many goods and services we use.

Creating a Standard Standard is created by appropriately qualified and experienced people who are brought together. They discuss and agree on the details that will form the new standard.

The organizations behind standards  American Society for Testing and Materials (ASTM)  European Committee for Standardization (CEN)  International Organization for Standardization (ISO)  Government departments  National organizations  Independent organizations  Trade associations  National standards bodies

About ASTM International  Established 1898  Provides an open forum for developing voluntary consensus standards used globally.  Non-profit, non-government organization funded primarily through the sale of its publications.  Publishes over 12,000 standards and various technical publications.  Over 32,000 members participating from over 115 nations.

How are standards used in legislation?  Used for regulation  Typically set health, safety or environmental criteria  Used for procurement  Sets the requirements that must be met by those supplying to the government

How are standards used in legislation?  U.S. food and drug administration  U.S. environmental protection agency  U.S. department of housing and urban development  U.S. department of defense

Regulatory agency U.S. food and drug administration modernization act indicates that the product manufacturer “ may declare conformity” to “ recognized” standards to meet some or all regulatory requirements. FDA publishes an annual list of “recognized medical devices standards” Includes deviations from the standard containing in a supplementary data sheet.

What all are there in standard? 1.Recognition List Number 2.Effective Date 3.Part B: Supplementary information 4.Item 201: ASTM F564-02(2006) 5.Date of Standard 6.Address of Standards Organization 7.Recognized Standards

What all are there in standard? 8.Devices Affected 9.Processes Affected 10. Type of Standard 11. Extent of Recognition 12. Related Citation and Product Codes 13. Regulation Number, Device Name, Device Class 14. Class Product 15. Technical Contact

Example: Standard Specification and Test Methods for Metallic Bone Staples. (Orthopaedics)  Recognized Consensus Standards  Recognition List Number: 016  Effective Date: 11/03/2006  Part B: Supplementary information  Item 201: ASTM F564-02(2006)

Date of Standard: 2006 Address of Standards Organization: ASTM International (ASTM) 100 Barr Harbor Drive West Conshohocken, PA CDRH Office and Division Associated with Recognized Standards: Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices (DGRND) Devices Affected: Metallic Bone Staples (non-spinal applications) Processes Affected: 510(K), PMA, IDE, PDP, HDE, Design Controls Type of Standard: Vertical, National, Test Method Extent of Recognition: Complete Standard Standard Specification and Test Methods for Metallic Bone Staples. (Orthopaedics)

Test methods provide examples of acceptable types of test setups and methods for the characterization of metallic bone staples. Additional information should be provided to document deviations from the standard as well as to document that the design of the product will provide adequate mechanical properties for the particular application. Related CFR Citations and Product Codes: CFR § Regulation Number Device Name Device Class Product Code § Plate, Fixation, BoneClass 2HRS§ Staple, Fixation, BoneClass 2JDR CFR § Regulation Number Device Name Device Class Product Code § Pin, Fixation, SmoothClass 2HTY§ Pin, Fixation, ThreadedClass 2JDW Standard Specification and Test Methods for Metallic Bone Staples. (Orthopaedics)

References store+vcdt

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