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Chemical disinfectants and antiseptics –Surgical hand disinfection – Test method and requirements.

This Standard specifies specifies a test method simulating practical conditions for establishing whether a product for surgical handrub and handwash reduces the release of resident and eventually present transient microbial flora on hands when used for the treatment of clean hands of volunteers.

This European Standard applies to products for surgical handrub or handwash for use in areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: in hospitals, in community medical facilities and in dental institutions; in clinics of schools, of kindergartens and of nursing homes; and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patient.

Respiratory protective devices - Methods of test - Part 7: Determination of particle filter penetration.

This Standard specifies the procedure for testing particle filter penetration for respiratory protective devices.

Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process.

This document specifies:
— the general principles governing the biological evaluation of medical devices within a risk management process;
— the general categorization of medical devices based on the nature and duration of their contact with the body;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyse the biological safety of the medical device;
— the assessment of the biological safety of the medical device.
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This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.

This document also gives guidelines for the assessment of biological hazards arising from:
— risks, such as changes to the medical device over time, as a part of the overall biological safety assessment;
— breakage of a medical device or medical device component which exposes body tissue to new or novel materials.
Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Devicespecific or product standards address mechanical testing.

This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.

Respiratory protective devices — Vocabulary and graphical symbols.

This document defines terms and specifies units of measurement for respiratory protective devices (RPDs), excluding diving apparatus. It indicates graphical symbols that can be required on RPDs, parts of RPD or instruction manuals in order to instruct the person(s) using the RPD as to its operation.

Chemical disinfectants and antiseptics — Hygienic handrub — Test method and requirements (phase 2/step 2).

This Standard specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of transient microbial flora on hands when rubbed onto the artificially contaminated hands of volunteers.

Textiles - Standard atmospheres for conditioning and testing.

This International Standard defines the characteristics and use of a standard atmosphere for conditioning, for determining the physical and mechanical properties of textiles and a standard alternative atmosphere that may be used if agreed between parties.

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03).

This Standard specifies identifies requirements for symbols used in medical device labeling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document.

Sterilization of health care products — Microbiological methods —Part 1: Determination of a population of microorganisms on products ).

Specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.

Clothing for protection against infectious agents — Medical face masks — Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected).

Describes a laboratory test method for measuring the resistance of medical face masks to penetration by a splash of synthetic blood.

This International Standard primarily addresses the performance of materials or certain material constructions used in medical face masks. This test method does not address the performance of the medical face mask's design, construction, interfaces or other factors which may affect the overall protection offered by the medical face mask and its operation (such as filtration efficiency and pressure drop) .

This test method does not evaluate the performance of medical face masks as a protection against contamination via airborne exposure pathways or in the prevention of the penetration of aerosolized body fluids deposited on the medical face mask.