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| articles:nist_traceability [2025/11/18 20:29] – rrandall | articles:nist_traceability [2025/11/18 20:33] (current) – [An "unbroken chain of calibrations" to what?] rrandall |
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| (b) (1) Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be __traceable to national or international standards__. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.</WRAP> | (b) (1) Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be __traceable to national or international standards__. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.</WRAP> |
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| <WRAP info center round box 80%>On February 2, 2024, the U.S. FDA issued an [[https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments|official ruling incorporating, by reference, the 2016 edition of ISO 13485]]. However, this incorporation does not change the requirements contained in Sec. 820.72(b)(1). ISO 13485:2016, sec. 7.6a also requires measuring equipment to be "//calibrated or verified, or both, at specified intervals or prior to use, against measurement standards traceable to international or national measurement standards...//".</WRAP> | <WRAP info center round box 80%>On February 2, 2024, the U.S. FDA issued an [[https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments|official ruling incorporating, by reference, the 2016 edition of ISO 13485]] (effective February 2, 2026). However, this incorporation does not change the requirements contained in Sec. 820.72(b)(1). Even if it did, ISO 13485:2016, sec. 7.6a also requires measuring equipment to be "calibrated or verified, or both, at specified intervals or prior to use, against measurement standards //traceable to international or national measurement standards...//".</WRAP> |
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| Similar antiquated language appears in [[http://everyspec.com/MIL-STD/MIL-STD-1300-1399/MIL-STD-1309D_87/|MIL-STD-1309D]], (12 February 1992), which doesn't even recognize international standards or offer alternatives where no national measurement standards exist: | Similar antiquated language appears in [[http://everyspec.com/MIL-STD/MIL-STD-1300-1399/MIL-STD-1309D_87/|MIL-STD-1309D]], (12 February 1992), which doesn't even recognize international standards or offer alternatives where no national measurement standards exist: |
