Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form
This document specifies the requirements and corresponding test methods for ultra-high-molecular-weight polyethylene (UHMWPE) powder moulding materials for use in the manufacture of moulded forms that are subsequently used in the manufacture of surgical implants.
This document is not applicable to UHMWPE moulding materials that were blended with any additives or different forms of polyethylene.
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 3: Accelerated ageing methods...
This document specifies a test method for investigating the oxidative stability of ultra-high-molecular-weight polyethylene (UHMWPE) moulded forms as a function of processing and sterilization method. This document describes a laboratory method for accelerated ageing of specimens taken from UHMWPE moulded forms or forms fabricated from these for use in the manufacture of surgical implants. The…
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms
This document specifies the requirements and corresponding test methods for moulded forms (e.g. sheets, rods and near net shape bars) made from ultra-high-molecular-weight polyethylene (UHMWPE) powder for use in the manufacture of surgical implants.
This document is not applicable to moulded forms that were intentionally irradiated, that were made from UHMWPE blended with additives or UHMWPE…
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 5: Morphology assessment meth...
This document specifies the test method for assessing the morphology of UHMWPE moulded forms as defined in ISO 5834-2.
The assessment of morphology of UHMWPE moulded forms is not required in routine monitoring of validated moulding process because alternative test methods as defined in ISO 5834-2, such as density and mechanical properties, already provide reasonable, redundant assurance of…
Cigarettes — Determination of menthol in total particulate matter from mainstream smoke — Gas-chroma...
ISO 13110:2012 specifies a method for the gas-chromatographic determination of menthol in the total particulate matter (TPM) of mentholated cigarette smoke condensates. The smoking of cigarettes and the collection of mainstream smoke are carried out in accordance with ISO 4387 with some exceptions.
Encapsulated menthol in specific products may lead to specific handling not described in ISO 13110:…
Biotechnology — Gene delivery systems — Part 1: Vocabulary
This document defines terms related to gene delivery systems.
This document is applicable to the general use of gene delivery systems across species and for all applications.
Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential per...
ISO 80601-2-61:2017 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.
These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors,…
Petroleum and related products — Determination of arsenic in crude petroleum using atomic fluorescen...
This document specifies a method for the determination of arsenic content in crude oil using atomic fluorescence spectrometry. Microwave digestion is used for pre-treatment of the oil sample into an inorganic solution.
