Category: EN standards

1 Scope This standard specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be re-sterilizable and medical devices intended to be sterilized by the processor. This standard specifies requirements for the information to be provided by the medical device manufacturer, so that the medical device can be processed safely and […]

4.1.5 The value assigned to a measurement standard at a given level shall be associated with an uncertainty of measurement that shall include inherited consecutive uncertainty contributions from measurement standards and measurement procedures at all higher levels of the calibration hierarchy. NOTE The chosen measure of uncertainty preferably should be estimated according to the GUM (see clause 6). 4.1.6 To […]

The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 16017. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 16017 are encouraged to investigate the possibility of applying the most recent editions of […]

1 Scope This test method covers equipment and techniques for determining porosity in noble metal coatings, particularly electrodeposits of gold, palladium and palladium-nickel alloy (70 % to 90 % palladium) and clad metals used on electrical contacts. The gel-bulk procedure is not as sensitive to small pores and is more complex than porosity tests involving gaseous corrodants (see ISO 14647 […]

1 Scope This European Standard specifies how a welding procedure specification for electron or laser beam welding is qualified by a welding procedure test. This standard is a part of a series of standards, details of this series are given in prEN ISO 15607, annex A. It defines the conditions for the execution of welding procedure qualification tests and the […]

1 Scope This International Standard specifies requirements for pumping or alternative means designed to remove normal accumulations of bilge water for small craft with a hull length, L H , up to 24 m according to ISO 8666. This International Standard does not set requirements for bilge pumps or bilge-pumping systems designed for damage control. 2 Normative references The following […]

1 Scope This European Standard gives guidance on tests used for characterizations of coatings produced by thermal spraying. It is not possible in this document to go into details regarding the different types of coatings and large numbers of coatings due to the fact that all meltable materials can be processed by thermal spraying and that so many and varied […]

1 Scope This part of ISO 1 4698 establishes the principles and basic methodology of a formal system of biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom technology is applied for that purpose. This part of ISO 1 4698 specifies the methods required for monitoring risk zones in a consistent way and for applying control measures appropriate […]

1 Scope This part of ISO 1 4692 gives the terms, definitions and symbols used in the specification, manufacture, testing and installation of glass-reinforced plastics (GRP) piping installations associated with offshore applications on both fixed and floating topsides facilities for oil and gas industry production and processing. It also describes the philosophy and provides guidance on the range of suitable […]

1 Scope This International Standard give guidelines on the use of screening methods used for the determination of aflatoxin M 1 content in milk and milk products, based upon competitive enzyme immunoassays. For legal purposes, positive enzyme immunoassay results require confirmation by an accepted reference method. However, depending on whether the test complies with the specifications given hereafter, enzyme immunoassays […]