ISO Medical Equipment Standards

This document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as ME equipment: - intended for use in an environment that provides specialized care for patients whose conditions can be...

This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment: ⎯ intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent...

This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment: - intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who...

This document applies to basic safety and essential performance of cerebral tissue oximeter equipment, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the probe attached to the head. The...

This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing...

This document focuses on monitoring the activity concentrations of radioactive gases. They allow the calculation of the activity releases, in the gaseous effluent discharge from facilities producing positron emitting radionuclides and radiopharmaceuticals. Such facilities produce short-lived...

This document provides guidance on the requirements of ISO 11135 that apply when parametric release is used to release the product after exposure to the sterilization process. It provides a path for transition of existing cycles, as well as a path for the development and implementation of a...

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...

This document describes laser radiation hazards arising in laser processing machines, as defined in 3.7. It also specifies the safety requirements relating to laser radiation hazards, as well as the information to be supplied by the manufacturers of such equipment (in addition to that...

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.

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...

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...

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...

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...

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...

This document provides calculation examples for different bevel gear designs regarding the scuffing load capacity according to ISO/TS 10300-20. The initial geometry data of the gear necessary for these calculations are in accordance with ISO 23509. The term "bevel gear" is used to...

This document specifies a calculation method for oil-lubricated hydrodynamic plain bearings with complete separation of the thrust collar and tilting pad thrust bearing surfaces by a film of lubricant. This document applies to plain thrust bearings with tilting-type sliding blocks (tilting pads),...

This document specifies a test method for determining the minimum volume fraction of oxygen, in admixture with nitrogen, at ambient temperature, that supports combustion of small vertical sheet test specimen under a specified gas velocity that is higher than that specified in ISO 4589-2....

This document specifies requirements and provides guidelines for establishing, developing, implementing, evaluating, maintaining and improving an effective compliance management system within an organization. This document is applicable to all types of organizations regardless of the type, size and...