ANSI/NCSL Z540.3-2006 – American National Standard for Calibration-Requirements for the Calibration of Measuring and Test Equipment.
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The objective of this National Standard is to establish the technical requirements for the calibration of measuring and test equipment.
This is done through the use of a system of functional components.
Collectively, these components are used to manage and assure that the accuracy and reliability of the measuring and test equipment are in accordance with identified performance requirements.
In implementing its objective, this National Standard describes the technical requirements for establishing and maintaining:
• the acceptability of the performance of measuring and test equipment;
• the suitability of a calibration for its intended application;
• the compatibility of measurements with the National Measurement System; and
• the traceability of measurement results to the International System of Units (SI).
In the development of this National Standard attention has been given to:
• expressing the technical requirements for a calibration system supporting both government and industry needs;
• applying best practices and experience with related national, international, industry, and government standards; and
• balancing the needs and interests of all stakeholders.
In addition, this National Standard includes and updates the relevant calibration system requirements for measuring and test equipment described by the previous standards, Part 11 of ANSI/NCSL Z540.1 (R2002) and Military Standard 45662A.
This National Standard is written for both Supplier and Customer, each term being interpreted in the broadest sense. The “Supplier may be a producer, distributor, vendor, or a provider of a product, service, or information. The “Customer” may be a consumer, client, enduser, retailer, or purchaser that receives a product or service.
Reference to this National Standard may be made by:
• customers when specifying products (including services) required;
• suppliers when specifying products offered;
• legislative or regulatory bodies;
• agencies or organizations as a contractual condition for procurement; and
• assessment organizations in the audit, certification, and other evaluations of calibration systems and their components.
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This National Standard is specific to calibration systems. A calibration system operating in full compliance with this National Standard promotes confidence and facilitates management of the risks associated with measurements, tests, and calibrations.8
Equipment intended for use in potentially explosive atmospheres (ATEX)
What are ATEX and IECEx?
ATEX (“ATmosphères EXplosibles”, explosive atmospheres in French) is a standard set in the European Union for explosion protection in the industry. ATEX 95 equipment directive 94/9/EC concerns equipment intended for use in potentially explosive areas. Companies in the EU where the risk of explosion is evident must also use the ATEX guidelines for protecting the employees. In addition, the ATEX rules are obligatory for electronic and electrical equipment that will be used in potentially explosive atmospheres sold in the EU as of July 1, 2003.
IEC (International Electrotechnical Commission) is a nonprofit international standards organization that prepares and publishes International Standards for electrical technologies. The IEC TC/31 technical committee deals with the standards related to equipment for explosive atmospheres. IECEx is an international scheme for certifying procedures for equipment designed for use in explosive atmospheres.
The objective of the IECEx Scheme is to facilitate international trade in equipment and services for use in explosive atmospheres, while maintaining the required level of safety.
In most cases, test equipment that is required to be operated in an explosive environment would be qualified and installed by the company’s facility services department and not the calibration personnel. One must also keep in mind that there would be two different avenues for the calibration of those pieces of test equipment:
on-site and off-site. If the test instrument that is used in an explosive environment must be calibrated on-site (in the explosive environment), then all the standards used for that calibration must also comply with explosive environment directives. However, if it were possible to remove the test equipment from the explosive environment when due for their period calibration, then there would be no requirement for the standards used for their calibration to meet the explosive
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environment directives, saving money on expensive standards and possibly expensive training of calibration personnel in order for them to work in those conditions.
Having said that, there may be a need for the calibration personnel to be aware of the ATEX regulations. An informative website for information on ATEX can be found by typing in the following link:
http://ec.europa.eu/enterprise/atex/indexinfor.htm. Several languages are available for retrieving the information.
Another informative website is the International Electrotechnical Commission Scheme for Certification to Standards Relating to Equipment for use in Explosive Atmospheres (IECEx Scheme). The link is: http://www.iecex.com/guides.htm.
1. Bucher, Jay L. 2007. The Quality Calibration Handbook.
Milwaukee: ASQ Quality Press.
2. The Story of the Egyptian Cubit. http://www.ncsli.org/misc/
cubit.cfm. (18 October, 2008)
3. 21CFR Part 211.68, 211.160: http://www.accessdata.fda.gov/
scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211/
(5 July, 2012)
4. 21CFR Part 11. http://www.fda.gov/downloads/
RegulatoryInformation/Guidances/ucm125125.pdf (5 July, 2012) and http://www.fda.gov/RegulatoryInformation/Guidances/
ucm125067.htm?utm_campaign=Google2&utm_
source=fdaSearch&utm_medium=website&utm_term=21 CFR part 11&utm_content=3
5. GAMP. http://en.wikipedia.org/wiki/Good_Automated_
Manufacturing_Practice (5 July, 2012)
6. NCSL International. 2006. ANSI/NCSL Z540.3-2006.
Boulder, CO.
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