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ISO DIS 21899 - Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks
March 7, 2019 - ISO

This document specifies the validation and verification requirements necessary for a biobank to be able to demonstrate that it operates its production of biological materials with validated and/or verified methods that are fit-for-purpose. This document is intended for the use by...

ISO TS 21726 - Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
February 1, 2019 - ISO

This document describes the basis for, selection of, and general applicability of a threshold of toxicological concern (TTC) value for a constituent present in/on a medical device or released from a medical device. The TTC values in this document can be used for: - comparing to a maximum...

ISO DIS 21151 - In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for international harmonization protocols establishing metrological traceability of values assigned to calibrators and human samples
March 13, 2019 - ISO

This International Standard specifies requirements for a protocol implemented by an international body to achieve equivalent results among two or more IVD MDs for the same measurand for cases where there are no reference measurement procedures and no fit-for-purpose certified reference...

ISO DIS 5840-1 - Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
January 14, 2019 - ISO

This part of ISO 5840 is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements. ISO 5840 is applicable to: newly developed and modified heart valve substitutes;...

ISO DIS 5840-3 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
January 14, 2019 - ISO

This part of ISO 5840 is applicable to all devices intended for implantation as a transcatheter heart valve substitute (see Annex A for examples). This part of ISO 5840 is applicable to both newly developed and modified transcatheter heart valve substitutes and to the accessory...

ISO DIS 5840-2 - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
January 14, 2019 - ISO

This part of ISO 5840 is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components. This part of...

ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
August 1, 2018 - ISO

This document specifies: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of medical devices based on the nature and duration of their contact with the body; - the evaluation of existing relevant...

ISO DIS 23368 - Anaesthetic and respiratory equipment — Low flow nasal cannulae for oxygen therapy
May 23, 2019 - ISO

This device-specific standard specifies requirements for low flow nasal cannulae, used in both home care 5 and hospital environments for the administration of oxygen therapy. This document does not include requirements to prevent the proliferation of fire within the tubing but does specify a...

ISO DIS 11890-2 - Paints and varnishes — Determination of volatile organic compound (VOC) and semi volatile organic compound (SVOC) content — Part 2: Gas-chromatographic method
April 23, 2019 - ISO

This document is one of a series of standards dealing with the sampling and testing of coating materials and their raw materials. It specifies a method for the determination of the volatile organic compounds (VOC) content and the semi-volatile organic compounds (SVOC) content of...

ISO DIS 15096 - Jewellery and precious metals - Determination of 999 0/00 silver - Difference method using ICP-OES
April 12, 2019 - ISO

This document specifies the analytical procedure for the determination of silver with a nominal content of and above 999 ‰ (parts per thousand). This document specifies a method intended to be used as the recommended method for the determination of silver of fineness of and above 999 ‰, including...

ISO DIS 8784-3 - Pulp, paper and board — Microbiological examination — Part 3: Enumeration of yeast and mould based on disintegration
April 8, 2019 - ISO

This part of ISO 8784 specifies a method for determining the total number of colony-forming units of yeast and mould in dry market pulp, paper and paperboard after disintegration. The enumeration relates to specific media.

ISO DIS 15007 - Road vehicles — Measurement and analysis of driver visual behaviour with respect to transport information and control systems
April 8, 2019 - ISO

This document defines key terms and parameters applied in the analysis of driver visual behaviour focused on glance and glance-related measures. It gives guidelines and minimum requirements on equipment and procedures for analysing driver visual behaviour including assessment of TICS to - plan...

ISO DIS 2702 - Fasteners - Heat-treated self-tapping screws - Mechanical and physical properties
April 5, 2019 - ISO

This document specifies the mechanical and physical properties of heat-treated self-tapping screws made of steel, with thread ST2,2 to ST9,5 in accordance with ISO 1478, together with the related test methods. Self-tapping screws are designed to form mating threads in materials into...

ISO/IEC DIS 17000 - Conformity assessment - Vocabulary and general principles
April 5, 2019 - ISO

This document specifies general terms and definitions relating to conformity assessment, including the accreditation of conformity assessment bodies, and to the use of conformity assessment to facilitate trade. A description of the functional approach to conformity assessment is included in Annex...

ISO DIS 21384-4 - Unmanned aircraft systems — Part 4: Terms and definitions
April 5, 2019 - ISO

This document defines terms and definitions relating to Unmanned Aircraft Systems that are widely used in science and technology.

ISO/IEC DIS 24091 - Information technology — Power efficiency measurement specification v3.0.3
April 5, 2019 - ISO

Abstract This document describes a standardized method to assess the energy efficiency of commercial storage products in both active and idle states of operation. A taxonomy is defined that classifies storage products in terms of operational profiles and supported features. Test definition and...

ISO DIS 12176-5 - Plastics pipes and fittings — Equipment for fusion jointing polyethylene systems — Part 5: Two-dimensional data coding of components and data exchange format for PE piping systems
April 5, 2019 - ISO

This part of ISO 12176 specifies an encoding system for data of components, assembly methods and jointing operations for polyethylene (PE) piping systems for gas, water and other industrial uses. These data may be used in a traceability system and/or used to perform the fusion of components...

ISO DIS 22031 - Sampling and test method for cleanable filter media taken from filters of systems in operation
April 5, 2019 - ISO

This International Standard specifies the sampling method of fabric filter media from filter system in operation and test method thereof to evaluate the degradation of filter media for dry type filtering dust collector (hereafter referred to as "bag filters") used in thermal power plants, municipal...

ISO DIS 21384-1 - Unmanned aircraft systems — Part 1: General specification
April 4, 2019 - ISO

This document specifies the general requirements for UAS for civil applications including commercial. This document provides the foundation and common terms, definitions and references relevant to the whole standard, the purpose of which is to provide a safety quality standard for the safe...

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