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1- Tests for absorbent cotton gauze, absorbent cotton and viscose gauze - EN 14079-1 The European Standard EN 14079-1 describes the physical and chemical test methods and requirements for the evaluation of absorbent cotton gauze, absorbent cotton and viscose gauze used as materials for compresses and wound packing products for medical use.
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2- Tests for absorbent cotton gauze, absorbent cotton and viscose gauze compresses and wound packing products -EN 14079-2 The European Standard EN 14079-2 describes the physical and chemical test methods and requirements for the evaluation of absorbent cotton gauze, absorbent cotton and viscose gauze compresses and wound packing products.
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3- Tests for nonwovens used in the manufacture of compresses for medical use- EN 1644-1 The European Standard EN 1644 -1 specifies the physical and chemical tests methods for the evaluation of Nonwovens used as materials for compresses for medical use.
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4- Tests for finished compresses for medical use- EN 1644-2 The European Standard EN 1644 -2 specifies the physical and chemical tests methods for the evaluation of finished nonwoven compresses.
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5- Tests for surgical gowns, drapes and clean air suits- EN 13795-1 The European Standard EN 13795 has the purpose to give general guidance on the characteristics of single-use and reusable surgical drapes, gowns and clean air suits. To comply with the EN 13795 series of standards, products shall meet all the requirements specified in Tables of Part 3 when tested according to EN 13795-2 throughout their useful life.
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6- Tests for plain paper, creped paper and nonwoven wrapping material - EN 868 -2 The European Standard EN 868-2 describes test methods and values for materials for sterile barrier systems and /or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
Plain paper
Creped paper
Nonwoven wrapping material
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7- Sterility tests - ISO 11737-2 Tests of sterility are carried through in accordance with ISO 11737-2 and consist of a direct aseptic immersion of the product, after the sterilization process, in a growth- promoting medium followed by incubation during a specific period of time. The number of samples needed for the sterility tests is at the discretion of the customer. Care should be taken in order to avoid inadvertent contamination of the product.
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8- Determination of a population of microorganisms on products (Bioburden) - ISO 11737-1 The knowledge of the bioburden is crucial during a sterilization process validation, as well as during routine control of manufacturing processes. The estimation of population of microorganisms is determined in accordance with EN ISO 11737-1. The number, as well as the sampling criteria is of the responsibility of the entity that subcontracts the analysis. The handling should be done in order to avoid inadvertent contamination of the product .The sampling should be done in double packing.
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9- Accelerated aging - ASTM F 1980-02 An accelerated aging study is used to support the assignment of an expiration date. Accelerated aging is a process in which products and/or packaging are stored in a environmental chamber at an elevated temperature (T) and/or humidity (RH), (if humidity effects are need to be considered), to simulate a longer period of real time aging.
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10- Tests for materials, sterile barrier systems and packaging systems- ISO 11607 ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
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11- Tests for absorbent cotton - Portuguese Pharmacopeia The Portuguese Pharmacopeia describes the physical, chemical test methods and requirements for the evaluation of absorbent cotton.
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12- Test for Absorbent Capacity od Dressings – ISO 11948 ISO 11948 defines the appropriate method for defining the absorption capacity of absorbent dressings
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13- Tests for Adhesiveness – ISO 29862, PSTC 101 ISO 29862 defines a set of methods for the determination of adhesiveness properties for adhesive materials. Tests of 90 and 180 ° and on different bases (stainless steel or other that imitate the application of the adhesive) are provided.
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14- Tests for endotoxins - AAMI ST72:2002/R2010 USP Chapter 85 defined the test method for detection and quantification of endotoxins from Gram negative bacteria using lysate from Limulus polyphemus or Tachypleus tridentatus. There are three techniques available for the test execution: gel-cloth (qualitative), turbidimetric and chromogenic (quantitative). The technique used by Bastos Viegas for quantification of endotoxins is the chromogenic.
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