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: 2006Address of Standards Organization:   ASTM International (ASTM)  100 Barr Harbor Drive  West Conshohocken, PA 19428-2959  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 ControlsType 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 §888.3030 Regulation

Number Device Name Device Class ProductCode §888.3030Plate, Fixation, BoneClass 2HRS§888.3030Staple, Fixation, BoneClass 2JDR 

CFR §888.3040 RegulationNumber Device Name DeviceClass Product Code §888.3040Pin, Fixation, SmoothClass 2HTY§888.3040Pin, Fixation, ThreadedClass 2JDW 

Standard Specification and Test Methods for Metallic Bone Staples. (Orthopaedics)

References

• http://www.nssf.info/Standards/Developers/index.xalte• http://www.iso-standards-international.com/what.htm• http://www.astm.org/cgibin/SoftCart.exe/index.shtml?

L+mystore+vcdt9564+1180786942• http://standards.gov/standards_gov/index.cfm• http://www.cen.eu/cenorm/homepage.htm• http://www.etsi.org/• http://www.nssf.info/index.xalter

Thanks for your attention