Kuwait published standards for Medical face masks, Sterilization of health care products, Medical devices, Respiratory protective devices Kuwait Standard & Metrology Department (KUWSMD) published following standards; Medical face masks - Requirements and test methods This document specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms. This European Standard is not applicable to masks intended exclusively for the personal protection of staff. NOTE 1 Standards for masks for use as respiratory personal protective equipment are available. NOTE 2 Annex A provides information for the users of medical face masks. Click here for notification Clothing for protection against infectious agents — Medical face masks 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. Click here for notification 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. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to 9. This document does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442-3, ICH Q5A(R1) and ISO 13022. This document does not apply to the microbiological monitoring of the environment in which health care products are manufactured. Click here for notification Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements 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. Click here for notification 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. Click here for notification Chemical disinfectants and antiseptics — Hygienic handrub 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. NOTE 1 Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions. This European Standard applies to products for hygienic handrub for use in areas and situations where disinfection is medically indicated. Such indications occur in patient care. Click here for notification Respiratory protective devices 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. Click here for notification Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process — 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. This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: — the patient's body during intended use; — the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others). 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. Device specific or product standards address mechanical testing. This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens. Click here for notification Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking This Standard specifies minimum requirements for filtering half masks as respiratory protective devices to protect against particles except for escape purposes. Laboratory and practical performance tests are included for the assessment of compliance with the requirements Click here for notification Products covered : Medical face masks, Sterilization of health care products, Medical devices, Respiratory protective devices HS Code: 300490, 340111, 340119, 340120, 340130, 340211, 340212, 340213, 340219, 340220, 340290, 380894, 901811, 901812, 901813, 901814, 901819, 901820, 901831, 901832, 901839, 901841, 901849, 901850, 901890, 901910, 901920, 902000 Proposed date of adoption:60 days from date of publication but it will be implemented in one day after approved by Kuwait ministry of commerce and industry due to corona virus (COVID-19) situation. Proposed date of entry into force:180 days but due to urgent situation of corona virus (COVID-19) it will be implemented in 7 days from date of publication of approved version by Kuwait ministry of commerce and industry, in line with health precautions related to dealing and limiting the spread of corona virus (COVID-19). Final date for comments: 60 days from notification | 
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