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This standard provides guidelines for precleaning, leak-testing, cleaning, packaging (where indicated), storage, highlevel disinfecting, and/or sterilizing of flexible gastrointestinal (GI) endoscopes; flexible bronchoscopes; flexible ear, nose, and throat endoscopes; surgical flexible...
ISO 15759:2005 specifies the dimensional and functional requirements for plastics caps with inserted elastomeric liners, attached to the infusion container [blow-fill-seal (BFS) container] by welding or by collar technique. These caps are intended for use in the packaging and handling of...
Inclusions This International Standard specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences...
This Standard specifies essential elements for using steam to sterilize medical devices in health care settings, with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to health care setting personnel and patients. Notes: 1) The term "health...
This European Standard specifies general requirements for dental equipment used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, packaging, marking, labelling, and information supplied...
This standard applies to mechanical refrigeration equipment consisting of an integrated single package refrigeration unit, or separate Unit Cooler and condensing unit sections, where the condensing section can be located either outdoor or indoor. Controls may be integral, or can be...
The scope of this European Standard is to set up a suitable measuring methodology allowing accurate measurement of the maximum sound pressure level produced by consumer's headphones and earphones when associated with personal music players.NOTE This standard does not apply to acoustically open or...
This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier properties, durability, package and seal integrity, visibility and appearance, processing, printing ink...
This design and evaluation guide describes seven categories for evaluating flexible medical packages and packaging materials. These include safety, barrier properties, durability, package and seal integrity, visibility and appearance, processing, and printing ink...
General This recommended practice provides guidelines for the selection and use of liquid chemical sterilants (LCSs)/highlevel disinfectants (HLDs) and gaseous chemical sterilizers that have been cleared for marketing by the U.S. Food and Drug Administration (FDA) for use in hospitals and other...
This part of ISO 9187 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products. It is applicable to ampoules with and without a colour break-ring; the provision of ampoules...
This part of ISO 9187 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products. It is applicable to ampoules with and without a colour break-ring; the provision of ampoules...
This part of ISO 9187 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products. It is applicable to ampoules with and without a colour break-ring; the provision of ampoules...
This part of ISO 8536 specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this part of ISO 8536 are intended...
This part of ISO 8536 specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this part of ISO 8536 are intended...
