BS EN ISO 4823:2015 pdf download – Dentistry — Elastomeric impression materials (ISO 4823:2015).
6 Pre-test planning approaches The information in this Clause is provided to help test operators avoid losses of time due to trial and error efforts occurring when such information is not taken into account before test procedures, such as those described in Clause 7, are begun. 6.1 Sampling Observe the following guidelines when procuring samples of materials for testing. a) Procure only samples that have been packaged for retail or franchise marketing and that have labelling Use by dates that have not expired. b) Wherever possible, select only those samples that have the same lot (batch) number [see 5.2.1 e)]. c) Sample size required — as much as 900 ml might be needed for conducting all of the required tests and for the considerable practice, that might be necessary for the test operator to become proficient in specimen preparation and testing, and — for the gypsum materials needed for the impression material compatibility with gypsum test, at least 1 000 g. 6.2 Pre-test product examinations These examinations are helpful in determining whether the sample procured (6.1) is fit for objective testing.
6.2.1 Examinations for compliance with labelling requirements Examine the consumer packaging components for compliance with the labelling requirements before any attempt to open a packaging component has defaced or obliterated any labelling entry information needed for storage or use of the product (for example, Use by date). NOTE At this point, it is recommended that the following information about the product be recorded for future reference in a test record format, if possible: — brand name, type, and class of the product, if applicable, along with an added numeric or alpha numeric symbol for the sample; — Use by date for the product; — lot number for each component. 6.2.2 Examinations for effectiveness of the packaging Before opening any primary packaging container, examine it for possibilities that the quality of the content might have been compromised since its manufacture. For example, evidence such as the following: — loose tube caps or canister lids or leakage; — container rupture or punctures; — shrinkage of the content of a container such as can be detected by sight, sound, or touch. Caution — Do not use any compromised materials for preparing specimens. 6.2.3 Examinations for compliance with requirements for instructions for use