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1 Scope 1.1 Standard addresses This Standard is intended to address the safe, effective, and reliable reprocessing of reusable medical devices at each phase of the reprocessing workflow, including a) establishing a QMS for the MDRA, including i) key performance indicators; ii) policies and procedures; iii) documentation; iv) roles and responsibilities; v) management review; vi) planning…

IEC 61010-031:2022 CMV contains both the official standard and its commented version. The commented version provides you with a quick and easy way to compare all the changes between IEC 61010-031:2022 edition 3.0 and the previous IEC 61010-031:2015+AMD1:2018 CSV edition 2.1. Furthermore, comments from IEC TC 66 experts are provided to explain the reasons of the most relevant changes, or to…

IEC 61010-031:2022 specifies safety requirements for hand-held and hand-manipulated probe assemblies for electrical test and measurement, and their related accessories. These probe assemblies are for non-contact or direct electrical connection between a part and electrical test and measurement equipment. They can be fixed to the equipment or be detachable accessories for the equipment. It has…

This document provides guidance for —    the sampling process of the aerosol particles in the air using filter media. This document takes into account the specific behaviour of aerosol particles in ambient air (Annex B). —    Two methods for sampling procedures with subsequent or simultaneous measurement: —    the determination of the activity concentration of radionuclides bound to aerosol…

This document specifies the general requirements, based on ISO 11074 and ISO/IEC 17025, for all steps in the planning (desk study and area reconnaissance) of the sampling and the preparation of samples for testing. It includes the selection of the sampling strategy, the outline of the sampling plan, the presentation of general sampling methods and equipment, as well as the methodology of the pre-…

This document specifies requirements for quality and competence in medical laboratories. This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies. This document is also…

This document specifies two procedures for the preparation of laboratory sheets prior to measuring optical properties. One is the preparation of pads in a Büchner funnel using a filter paper or a wire screen and the other one is the preparation of laboratory sheets in a standard sheet former (conventional or Rapid Köthen). This document is applicable to all wood pulps and to most other types of…

1 Scope 1.1 Purpose This Standard specifies general requirements related to the safety of human CTOs used for transplantation, and includes quality system requirements. It includes aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to or affected by the transplantation of CTOs. 1.2 Areas of application This Standard applies to…

1 Scope 1.1 Purpose This Standard addresses issues related to the safety of human perfusable organs used for transplantation. It includes quality system requirements and aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to, or affected by, the transplantation of perfusable organs. 1.2 Areas of application This Standard applies to…

This document specifies a test method for preparation of test prints produced with liquid printing inks, either water-based, solvent-based or radiation cured printing inks as used in flexography and gravure printing. Such test prints are intended to be used for reflection-based measurements, such as colorimetry and optical density as well as for testing light fastness, and the resistance of…