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ISO 21220:2008 refers to particulate air filters for general ventilation. It describes testing methods and the test rig for measuring filter performance. The test rig is designed for an air flow rate between 0,25 m3/s (900 m3/h, 530 ft3/min) and 1,5 m3/s (5 400 m3/h, 3 178 ft3/min). ISO 21220:2008 applies to air filters having an initial efficiency of less than 99 % with respect to 0,4 �m…

ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how the standard is applied are also included in informative…

ISO 24490:2016 specifies the minimum requirements for the design, manufacture and testing of centrifugal pumps for cryogenic service. ISO 24490:2016 does not apply to reciprocating pumps. This International Standard also gives guidance on the design of installations (see Annex A). It does not specify requirements for operation or maintenance. NOTE For general requirements for materials used in…

ISO 6578:2017 specifies the calculation procedure to convert the volume of liquefied petroleum gas (LPG) and liquefied natural gas (LNG) under the conditions at the time of measurement to the equivalent volume of liquid or vapour at the standard condition, i.e. 15 °C and 101,325 kPaA, or to the equivalent mass or energy (calorific content). It applies to the quantities of refrigerated hydrocarbon…

IEC 60601-1:2005+A1:2012, 1.1 is replaced by: This document applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment. This document applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services. NOTE 1 A party that assembles on…

This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment by a single patient in…

This document establishes the terms, definitions, methodologies, and calculations that are necessary for the recovery of waste from plastic products and materials labelled as industrially compostable (hereafter referred to as compostable plastic waste) through organic recycling. The document identifies the different types of organic recycling technologies used in the recovery and subsequent…

ISO 11161:2007 specifies the safety requirements for integrated manufacturing systems (IMS) that incorporate two or more interconnected machines for specific applications, such as component manufacturing or assembly. It gives requirements and recommendations for the safe design, safeguarding and information for the use of such IMSs. ISO 11161:2007 is not intended to cover safety aspects of…

IEC 60601-2-31:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as defined in 201.3.206. HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this…

ISO 14577-1:2015 specifies the method of instrumented indentation test for determination of hardness and other materials parameters for the following three ranges: macro range: 2 N ≤ F ≤ 30 kN; micro range: 2 N > F; h > 0,2 µm; and nano range: h ≤ 0,2 µm. For the nano range, the mechanical deformation strongly depends on the real shape of indenter tip and the calculated material parameters…