ISO/TR 16178-2012 pdf free.Footwear – Critical substances potentially present in footwear and footwear components.
This Technical Report describes the critical chemical substances, their potential risks, the materials in which they can be found and the test method(s) which can be used to quantify them. It does not include requirements; it is the responsibility of the user of this Technical Report to fix his/her level of acceptance, for instance using a defined concentration or detection limit or quantification limit.
NOTE The proposed test methods indicate the state of the art. Some substances do not include a test method, as no test method is available at the time of publication of this Technical Report. If possible, it is intended to include a test method in a revision of this Technical Report.
This Technical Report applies to any kind of footwear and footwear components.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1 allergen
substance that Is capable of inducing an allergic reaction
2.2 allergy
immunologically mediated response to certain specific substances
NOTE 1 The specific substances are allergens.
NOTE 2 Type-i allergy (respiratory allergy) is mediated by lgE antibodies and can cause asthma, rhinitis and urticaria. NOTE 3 Type-4 allergy (dermal allergy) is mediated by T-cells and can cause dermatitis,
2.3 detection limit
value from which a substance is considered detectable
NOTE This means that the signal associated to the substance is three times bigger than the background noise signal, The limit of detection is determined experimentally by the laboratory for each substance.
2.4 quantification limit
value from which a substance is considered measurable
NOTE It is the value where the uncertainty of measurement is equal to 50 % of the determined value.
2.5 absence of a chemical
state in which a chemical is lacking from a material, where the test method is unable to detect it
NOTE The amount of the chemical is smaller than the detection limit of the test method.ISO/TR 16178 pdf free download.
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