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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 16073-5 - Wildland firefighting personal protective equipment - Requirements and test methods - Part 5: Helmets
February 19, 2019 - ISO

This document specifies the minimum performance requirements and methods of test for helmets used for wildland firefighting. This document covers the general design of wildland firefighting helmets, the minimum levels of performance for the materials employed and the methods of test used....

ISO DIS 16073-3 - Wildland firefighting personal protective equipment - Requirements and test methods - Part 3: Clothing
January 23, 2019 - ISO

This document specifies methods of test and minimum performance requirements for personal protective clothing, designed to protect the wearer's body, except for the head, hands, and feet, that is worn during wildland firefighting and associated activities. This clothing is not intended to provide...

ISO DIS 16073-7 - Wildland firefighting personal protective equipment - Requirements and test methods - Part 7: Face and eye protection
January 24, 2019 - ISO

This document specifies the minimum performance requirements and methods of test for personal protective equipment (PPE) face & eye protection, for wildland firefighting. This document covers the general design of the PPE, the minimum levels of performance for the materials employed and the...

ISO DIS 16073-8 - Wildland firefighting personal protective equipment - Requirements and test methods - Part 8: Hearing
January 23, 2019 - ISO

This document specifies the minimum performance requirements and methods of test for hearing protection used when wildland firefighting. This document covers the general design of the PPE, the minimum levels of performance for the materials employed and the methods of test used. This PPE is...

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 16073-1 - Wildland firefighting personal protective equipment - Requirements and test methods - Part 1: General
January 24, 2019 - ISO

This document specifies the minimum performance requirements and methods of test for personal protective equipment (PPE) covering the torso, neck, arms, hands, legs, feet, head, eyes and hearing that is used for wildland firefighting. This document covers the general design of the PPE, the minimum...

ISO DIS 16073-4 - Wildland firefighting personal protective equipment - Requirements and test methods - Part 4: Gloves
February 1, 2019 - ISO

This document specifies the minimum performance requirements and methods of test for personal protective equipment (PPE), gloves, that cover the hands whilst wildland firefighting. This document covers the general design of the PPE, the minimum levels of performance for the materials...

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 10993-18 - Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Évaluation biologique
August 8, 2018 - ISO

This document specifies a framework for the identification of biological hazards and the estimation and control of biological risks from material constituents, using a stepwise approach to the characterization of a medical device through: - the identification of its...

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/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 21982 - Assembly tools for screws and nuts - Ratcheting wrenches - Technical requirements
March 21, 2019 - ISO

This International Standard specifies the dimensions and technical requirements for ratcheting wrenches used in assembly or disassembly of hexagonal and double hexagonal fasteners. NOTE The wrenches covered by this standard are the ones identified in ISO 1703:2018 under reference No.1 1 01...

ISO DIS 19440 - Enterprise modelling and architecture - Constructs for enterprise modelling
March 19, 2019 - ISO

This standard identifies and specifies constructs necessary for users who are modelling enterprises in conformance with EN ISO 19439:2008. This standard focuses on, but is not restricted to, engineering and the integration of manufacturing and related services in the enterprise. The...

ISO 20387 - Biotechnology - Biobanking - General requirements for biobanking
August 1, 2018 - ISO

This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality. This document is applicable to all organizations...

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