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ISO 4823 - Dentistry — Elastomeric impression and bite registration materials
February 1, 2021 - ISO

This document specifies the requirements and their test methods for elastomeric impression and bite registration materials. NOTE This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405...

ISO 21899 - Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks
June 1, 2020 - ISO

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

ISO 10993-12 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
January 1, 2021 - ISO

This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993...

ISO 10993-23 - Biological evaluation of medical devices - Part 23: Tests for irritation
January 1, 2021 - ISO

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts...

ISO 21912 - Solid recovered fuels — Safe handling and storage of solid recovered fuels
February 1, 2021 - ISO

This document provides principles and requirements for safe handling, treatment and storage of solid recovered fuels (SRF), prepared from non-hazardous waste, to be used for energy purposes. This document covers process stages from point of acceptance of material to point of delivery of SRF....

ISO 28399 - Dentistry — External tooth bleaching products
March 1, 2021 - ISO

This document specifies the requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of...

ISO 5840-1 - Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
January 1, 2021 - ISO

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

ISO TR 22758 - Biotechnology — Biobanking — Implementation guide for ISO 20387
May 1, 2020 - ISO

This document provides guidance to biobanks on how to implement the quality management, management, and technical requirements of ISO 20387. It expands on aspects of ISO 20387 and provides examples for illustration purposes. The aim of this document is to assist biobanks to address...

ISO 5840-2 - Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
January 1, 2021 - ISO

This document 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 document is applicable to...

ISO TS 10993-19 - Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
March 1, 2020 - ISO

This document provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, i.e. physico‑chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to...

ISO 10993-18 - Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
January 1, 2020 - ISO

This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally...

ISO DIS 9564-5 - Financial services — Personal Identification Number (PIN) management and security — Part 5: Methods for the generation, change, and verification of PINs and card security data using the advanced encryption standard
April 14, 2021 - ISO

This document provides requirements and guidance for methods of Issuer PIN Management using AES. It additionally defines a method for generating and verifying Card Security Codes using AES. The processes defined in this Standard (in order as presented) are: - PIN Generation - PIN Change - PIN...

ISO DIS 5383 - Agricultural tyres for lawn and garden tractors — 3-part code designated tyres
April 5, 2021 - ISO

A paragraph. This document establishes the designation, the dimensions, the approved rim contours and the load ratings for 3-part code designated tyres in diagonal or radial construction for lawn, garden tractors and agricultural machines, with a nominal rim diameter code 18 and below.

ISO 27269 - Health informatics — International patient summary
April 1, 2021 - ISO

This document defines the core data set for a patient summary document that supports continuity of care for a person and coordination of their healthcare. It is specifically aimed at supporting the use case' scenario for 'unplanned, cross border care' and is intended to be an international patient...

ISO/IEC 24800-2 - Information technology — JPSearch — Part 2: Registration, identification and management of schema and ontology
April 1, 2021 - ISO

This document specifies a series of interfaces to allow disparate systems an interoperable management of image repositories. It also specifies the general rules which govern the usage of metadata in JPSearch and provides a specification which - provides rules for the representation of image...

ISO 20579-3 - Surface chemical analysis — Sample handling, preparation and mounting — Part 3: Biomaterials
April 1, 2021 - ISO

This document gives guidance on methods of handling, mounting and surface treatment for a biomaterial specimen prior to surface chemical analysis. It is intended for the analyst as an aid in understanding the specialized specimen-handling conditions required for analyses by the following...

ISO 19148 - Geographic information — Linear referencing
April 1, 2021 - ISO

This document specifies a conceptual schema for locations relative to a one-dimensional object as measurement along (and optionally offset from) that object. It defines a description of the data and operations required to use and support linear referencing. This document is applicable to...

ISO 23692 - Microbeam analysis — Electron probe microanalysis — Quantitative analysis of Mn dendritic segregation in continuously cast steel product
April 1, 2021 - ISO

This document specifies procedures for quantitative analysis of Mn dendritic segregation in steel billets, blooms, slabs using electron probe microanalysis (EPMA). This document is mainly applicable to continuously cast products with Mn content more than 0,01 % by mass. It can also be used for...

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