![]() ![]() If a single sampling plan is used, Table 2-A of the standard indicates the number of samples (the sample size) to be inspected for the production evaluation. Inspection type (tightened normal reduced)ĪNSI / AAMI PB70-2012 requires an AQL of 4.0% and an RQL of 20%.įor the AQL of 4.0%, the standard ISO 2859-1 can be used to calculate the number of individual samples for various lot sizes.įor this example, if the lot size is 1 000 10 000 or 100 000 units, with a Normal inspection type and an inspection Level II, a look at Table 1 of the standard identifies the sample size code letters.įor these lot sizes, the sample size code letters are J, L and N, respectively for 1 000 10 000 and 100 000 units.When those two parameters are part of a specification requirements, they imply that the tested finished goods must be submitted to a specific sampling plan which depends on three parameters : The AQL is defined as the Acceptance Quality Level expressed in % and the RQL is the Rejectable Quality Level also expressed in %. This statistical approach introduces two parameters of quality level: AQL and RQL ![]() What is the AQL 4.0% and the RQL 20% mentioned in the AAMI PB70-2012 specification?Ī statistical approach has been developed to limit the producer’s risk (the highest defective rate considered acceptable in the process) and the consumer’s risk (the highest defective rate accepted by the customer). ![]()
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