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4 Quality management system elements 4.1 Documentation 4.1.1 Procedures for the development, validation, routine control and product release from sterilization shall be specified. 4.1.2 Documents and records required by this part of ISO 17665 shall be reviewed and approved by designated personnel (see 4.2.1). Documents and records shall be controlled in accordance with the applicable clauses of ISO 13485. 4.2 […]

4.4 Measurement, analysis and improvement — Control of nonconforming product Procedures for control of product designated as nonconforming and for correction, corrective action and preventive action shall be specified. These procedures shall comply with the applicable clauses of ISO 13485. 5 Sterilizing agent characterization 5.1 Sterilizing agent The composition, storage conditions and shelf life for the sterilizing agent shall be […]

4 Design requirements 4.1 General characteristics The equipment is a warning system designed to detect radioactivity of gamma emitters contained in recyclable or non-recyclable materials, issuing a visual and/or audible alarm, when the signal from the radiation detection system exceeds an alarm threshold.  The alarm threshold is not a fixed value, but an expected value depending on the measuring […]

The numbers given in brackets are the tolerances defining the range of acceptable values for the results of either the type testing reference measurements specified in Clause 7 or the routine measurements specified in Clause 8. If the published tolerance requirement cannot be met, then the 95 % confidence level that is achievable should be reported. It shall then be […]

For peripheral units (measuring transducers etc.), or if the equipment is in a decentralized configuration, then if the above humidity stresses are exceeded, the actual humidity occurring at the location of the equipment concerned shall be used in the design. 4.2 Special service conditions Special arrangements shall be agreed between the appropriate parties involved when service conditions can be proved […]

4 Clothing design 4.1 General Protective clothing for firefighters capable of satisfying the levels of performance specified in this European Standard shall protect the wearer’s body, except the head, hands and feet. It may be comprised of:  a coverall,  a suit provided with an interface area, or  a number of inner and/or outer garments designed to be […]

1 Scope 1.1 Main purpose This European standard defines the characteristics required to synthetically describe the organisation and content of human anatomy within a terminological system. It is intended primarily for use with computer-based applications such as clinical electronic health records, decision support and for various bio-medical research purposes. This European standard will serve to facilitate the construction of new […]

5.5 Preliminary information Prior to the test, the AE Test Organisation shall collect the following information: a) relevant Product Standard; b) type of equipment or structure and material characteristics and specifications; c) design- and test pressure; d) working- and test temperature; e) assembly and/or layout drawings with sufficient details of the structure; f) material specifications, including heat treatment; if applicable […]

1 Scope This European Standard specifies a method for determining the dissolved residual matter in liquefied petroleum gases (LPG), in the range of 40 mg/kg to 100 mg/kg. Higher concentrations can be determined by adjusting the sample size. The dissolved residue is the amount of organic compounds that are detectable by gas chromatography after evaporation of the sample at ambient […]

1 Scope This document specifies a pull-out test method for the verification of the applicability of the declared outer diameter of the transverse bars with corrosion protection coating φ tot,g in the calculation of the anchorage capacity of transverse anchorage bars (see A.10.3 in prEN 12602:2006) in prefabricated reinforced components of autoclaved aerated concrete (AAC). 2 Normative references The following […]