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6 Posts in this encyclopedia categorySimulant Solutions
Food simulants are standardised test solutions that mimic different food categories and are used to determine migration of substances from food contact materials. EU Regulation (EU) No 10/2011 defines four simulants (A, B, C, D) for plastics.
Standard
A standard is a document that establishes, by consensus and approved by a recognised standardisation body, requirements, specifications, guidelines, or characteristics for products, processes, or services. Standards are voluntary in principle but can become mandatory through legislation or regulation.
STERILE EO
STERILE EO designates medical devices sterilised using ethylene oxide (EO) gas. EO sterilisation is a low-temperature process suitable for heat-sensitive materials such as plastics and polymers. The symbol is standardised in ISO 15223-1. The sterility assurance level (SAL) of validated EO processes is typically 10⁻⁶.
STERILE R
STERILE R designates medical devices sterilised by ionising radiation – typically gamma radiation (Co-60) or electron beam. The process is governed by ISO 11137 and achieves a sterility assurance level (SAL) of 10⁻⁶. It is suited to single-use articles, plastics, and pre-packaged products, and leaves no chemical residues.
Suitable for food
Food grade designates products approved for direct or indirect contact with foodstuffs. The legal basis is EU Regulation (EC) No 1935/2004. Gloves used in food processing must demonstrate that no substances migrate to food in quantities that could endanger human health or impair food quality.