ISO 10993-18:2020 pdf download – Biological evaluation of medicaldevices — Part 18: Chemical characterization of medical device materials within a risk management process
ISO 10993-18:2020 pdf download – Biological evaluation of medicaldevices — Part 18: Chemical characterization of medical device materials within a risk management process. 5.9 Assess the actual chemical release (leachables profile) Results of leachables studies, including both targeted leachables and...
ISO 10993-15:2019 pdf download – Biological evaluation of medicaldevices— Part 15: Identification and quantification of degradation products from metals and alloys
ISO 10993-15:2019 pdf download – Biological evaluation of medicaldevices— Part 15: Identification and quantification of degradation products from metals and alloys. 5.3.4 Sample surface condition Since the surface condition of a material can affect its electrochemical behaviour, the surface condition...
ISO 10993-12:2021 pdf download – Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
ISO 10993-12:2021 pdf download – Biological evaluation of medical devices — Part 12: Sample preparation and reference materials. NOTE The use of an kM will facilitate the comparability of the response between laboratories and help assess reproducibility of the test...
ISO 10993-9:2019 pdf download – Biological evaluation of medicaldevices— Part 9: Framework for identification and quantification of potential degradation products
ISO 10993-9:2019 pdf download – Biological evaluation of medicaldevices— Part 9: Framework for identification and quantification of potential degradation products. The approved study plan for multi-component devices shall take into account each individual component/material and shall consider synergistic effects on...
ISO 10993-3:2014 pdf download – Biological evaluation of medicaldevices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-3:2014 pdf download – Biological evaluation of medicaldevices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. When considering whether a carcinogenicity study should be performed, the role of the study In the evaluation of human risk shall...
ISO 10993-1:2018 pdf download – Biological evaluation of medicaldevices— Part 1: Evaluation and testing within a risk management process
ISO 10993-1:2018 pdf download – Biological evaluation of medicaldevices— Part 1: Evaluation and testing within a risk management process. 4.9 The biological risk assessment of materials or final products shall be re—evaluate(l if any of the following occur: a) any...
ISO 10976:2015 pdf download – Refrigerated light hydrocarbon fluids — Measurement of cargoes on board LNG carriers
ISO 10976:2015 pdf download – Refrigerated light hydrocarbon fluids — Measurement of cargoes on board LNG carriers. See Tables C.4 and C for examples of sections of thermal correction tables for a radar-type level gauge and float-type level gauge, respectively....
ISO 10968:2020 pdf download – Earth-moving machinery —Operator’s controls
ISO 10968:2020 pdf download – Earth-moving machinery —Operator’s controls. 4.5 Pedals The surface of pedals shall be slip-resistant. 5 Movement of controls 5.1 General 5.1.1 The type, location and method of operation of typical primary controls shall be according to...
ISO 10931-5:1998 pdf download – Plastics piping systems for industrialapplications – Poly(vinylidene fluoride)(PVDF)— Part 5: Fitness for purpose of the system
ISO 10931-5:1998 pdf download – Plastics piping systems for industrialapplications – Poly(vinylidene fluoride)(PVDF)— Part 5: Fitness for purpose of the system. This part of ISO 10931 specifies the requirements for the fitness for purpose of piping systems made from poly(vinyfidene...
ISO 10893-10:2011 pdf download – Non-destructive testing of steel tubes —Part 10: Automated full peripheral ultrasonictesting of seamless and welded (exceptsubmerged arc-welded) steel tubes for the detection of longitudinal and/ortransverse imperfections
ISO 10893-10:2011 pdf download – Non-destructive testing of steel tubes —Part 10: Automated full peripheral ultrasonictesting of seamless and welded (exceptsubmerged arc-welded) steel tubes for the detection of longitudinal and/ortransverse imperfections. 4 General requirements 4.1 Unless otherwise specified by the...