ISO 21563-2013 pdf download.Dentistry – Hydrocolloid impression materials.
ISO 21563 specifies the requirements and tests for helping determine whether the elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also specifies requirements for labelling and instructions for use.
NOTE This International Standard specifies no requirements or tests for freedom from unacceptable biological hazards. However, it is recommended that, to address possible biological hazards associated with the use of hydrocolloid impression materials, interested parties should refer to ISO 7405 and ISO 10993.
2 Normative references
The following referenced documents are indispensable for application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 6873, Dentistry — Gypsum products
ISO 3696, Water for analytical laboratory use — Specification and test methods
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1 bonding
adherence o the reversible and non-reversible impression material components constituting a single impression after each of the separate but interfacing materials has reached the level of elasticity and effective setting required for successful removal from the mouth
3.2 bulk container
labelled consumer packaging or primary packaging container holding a greater amount of otherwise unpackaged granular, liquid, powder, or other loose substance than is usually needed for a single dental clinical or laboratory procedure
3.3 combined reversible/non-reversible impression material system
system of impression making in which a light bodied agar material is first syringed around selected teeth so that it can bond with the non-reversible alginate material that will be forced over it later during the formation of an impression
5 Requirements — Characteristics and properties
The requirements applicable to only one category of hyd rocolloid impression materials (agar or alginate)
are stated immediately below in 51. to 55, The requirements applicable to both categories are displayed
in Table 1 which constitutes a part of Clause 5.
5.1 Consistency (agar impression materials of all Types, in the sol state only)
After being exposed to the recommended storing temperature treatment recommended in the manufacturer’s instructions, the material shall have a consistency that will allow the entire content of the tube or syringes to be extruded within 30 s. No specimens need to be made but material shall be tested to see if all can be extruded within 30s.
5.2 Working time (alginate materials only)
When tested in accordance with 7.1. the thickness of the layer of material remaining between the tip of the test penetrator and the test base plate shall not exceed 0,25 mm.
5.3 Initial setting time (alginate materials only)
When tested in accordance with 22. the initial setting time shall be within 20 % of that stated in the manufacturer’s instructions 18.2.3 h)I
5.4 Linear dimensional change (Type 3A agar materials only)
When tested in accordance with Z. the dimensional change shall not exceed 1,0 %
5.5 Tensile bond strength (Type 3A agar materials only)
When tested in accordance with 29. the minimum tensile bond strength shall not be less than 50 kPa.ISO 21563 pdf free download.
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