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Uued standardid


EVS-EN ISO 80369-1:2018
Hind 15,40 EUR
Identne ISO 80369-1:2018; EN ISO 80369-1:2018
Meditsiinis kasutatavad väikseavalised liitmikud vedelikele ja gaasidele. Osa 1: Üldnõuded
This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient. This document also specifies the healthcare fields in which these small-bore connectors are intended to be used. These healthcare fields include, but are not limited to: — breathing systems and driving gases; — enteral; — limb cuff inflation; — neuraxial; — intravascular or hypodermic. This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that will be developed under future parts of the ISO 80369 series. This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. NOTE 1 Clause 7 allows for additional designs of small-bore connectors for new applications for inclusion in the ISO 80369 series. NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO 80369 series into medical devices, medical systems or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, the risks associated with changing to the new small-bore connectors as specified in the ISO 80369 series of standards will be considered. NOTE 3 The connectors specified in the ISO 80369 series are intended for use only in their specified application. Use of these connectors for other applications increases risk that a hazardous misconnection could occur. NOTE 4 Manufacturers and responsible organizations are encouraged to report their experience with the small-bore connectors specified in the ISO 80369 series to the Secretariat of ISO/TC 210 so that this feedback can be considered during the revision of the relevant part of the ISO 80369 series.

ISO 15883-4:2018
Hind 168,97 EUR
Washer-disinfectors -- Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
This document specifies the particular requirements, including performance criteria for washer-disinfectors (WD) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes. This document also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which can be required to achieve the necessary performance criteria. The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring, and requalification of WD periodically and after essential repairs, are also specified. NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this document. NOTE 2 WD complying with this document can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this method of disinfection. WD complying with the requirements of this document are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2006+Amd 1:2014, 4.1.5). The specified performance requirements of this document do not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 3 If it is considered that prion protein might be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein and/or other protein in a manner that can inhibit its removal or inactivation from the load or washer-disinfector. NOTE 4 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.
Asendab ISO 15883-4:2008

ISO 7886-4:2018
Hind 49,50 EUR
Sterile hypodermic syringes for single use -- Part 4: Syringes with re-use prevention feature
This document specifies requirements for sterile single-use hypodermic syringes made of plastic and rubber materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use. This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], auto-disable syringes for fixed dose immunization (ISO 7886‑3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in this document. NOTE Syringes designed to reduce the risk of needle-stick injuries can also comply with this document with regard to their re-use prevention properties, but it is stressed that anti-needle-stick properties of syringes are not in themselves addressed in this document.
Asendab ISO 7886-4:2006

ISO 11979-1:2018
Hind 32,43 EUR
Ophthalmic implants -- Intraocular lenses -- Part 1: Vocabulary
This document defines terms applicable to intraocular lenses, and to the methods used to evaluate them. NOTE Terms are listed in the alphabetical order of the English terms in the English version of this document.
Asendab ISO 11979-1:2012

CEN/TR 17296:2018
Hind 5,62 EUR
Chemical disinfectants and antiseptics - Differentiation of active and non-active substances
This document defines how to exclude or confirm that an excipient in a biocidal product is an active substance within the frame of the European Biocidal Product Regulation and other regulations.

ISO 20184-1:2018
Hind 100,70 EUR
Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for frozen tissue -- Part 1: Isolated RNA
This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate RNA extracted from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

ISO 21976:2018
Hind 75,10 EUR
Packaging -- Tamper verification features for medicinal product packaging
This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

ISO 81060-2:2018
Hind 134,84 EUR
Non-invasive sphygmomanometers -- Part 2: Clinical investigation of intermittent automated measurement type
This document specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff. This document is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation. This document covers sphygmomanometers intended for use in all patient populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment for self-measurement as well as use in a professional healthcare facility). EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical investigation according to this document. This document specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have passed a clinical investigation according to this document. This document is not applicable to clinical investigations of non-automated sphygmomanometers as given in ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.
Asendab ISO 81060-2:2013

Asendatud või tühistatud standardid


EVS-EN ISO 80369-1:2010
Identne ISO 80369-1:2010; EN ISO 80369-1:2010
Väikese läbimõõduga ühendusliitmikud vedeliku ja gaasiga töötavatele meditsiiniseadmetele. Osa 1: Üldnõuded (ISO 80369-1:2010)
This part of ISO 80369 specifies general requirements for SMALL-BORE CONNECTORS, which convey liquids or gases in healthcare APPLICATIONS. These SMALL-BORE CONNECTORS are used in MEDICAL DEVICES or ACCESSORIES intended for use with a PATIENT. This International Standard also specifies the healthcare fields in which these SMALL-BORE CONNECTORS are intended to be used. These healthcare fields of use include, but are not limited to, APPLICATIONS for: - BREATHING SYSTEMS and driving gases, - enteral and gastric, - urethral and urinary, - limb cuff inflation, - neuraxial devices, and - intravascular or hypodermic. SMALL-BORE CONNECTORS as specified in this International Standard are NON-INTERCONNECTABLE with: - the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006; - the temperature sensor CONNECTOR and mating ports specified in Annex DD of ISO 8185:2007; and - the nipples of EN 13544-2:2002. This International Standard provides the methodology to assess NON-INTERCONNECTABLE characteristics of SMALL-BORE CONNECTORS based on their inherent design and dimensions in order to reduce the RISK of misconnections between MEDICAL DEVICES or between ACCESSORIES for different APPLICATIONS and to reduce the RISK of misconnections between MEDICAL DEVICES with 6 % Luer CONNECTORS, and all other non-Luer CONNECTORS that will be developed under future parts of this series of standards. It does not specify requirements for the MEDICAL DEVICES or ACCESSORIES that use these SMALL-BORE CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES.
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prEN ISO 11117
Identne ISO/DIS 11117; prEN ISO 11117
Tähtaeg 3.02.2019
Gas cylinders - Valve protection caps, guards and shrouds - Design, construction and tests (ISO/DIS 11117:2018)
This document specifies the requirements for valve protection caps, valve guards and shrouds used on cylinders for liquefied, dissolved or compressed gases. Valve protection caps, valve guards or shrouds are some of the options available to protect cylinder valves (including Valves with Integral Pressure Regulators, abbreviated VIPRs) during transport. While this document is applicable to valve protection caps, valve guards and shrouds which inherently provide the primary protection of a cylinder valve, it might also be beneficially used to test other equipment attached to cylinder packages, even in cases where the cylinder valve is inherently able to withstand damage without release of the content. NOTE Small cylinders (e.g. medical) are commonly transported in an outer-packaging (e.g. pallet) to meet transport regulations. This document does not specify requirements that might be necessary to enable the valve protection device to be used for lifting the cylinder.
Keel: Inglise

prEN IEC 63009:2018
Identne IEC 63009:201X; prEN IEC 63009:2018
Tähtaeg 3.02.2019
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 20 kHz to 0.5 MHz
This International Standard is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating ultrasound in the frequency range 20 kHz to 500 kHz. This standard only relates to ultrasonic physiotherapy equipment employing a single plane non-focusing circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head. This standard specifies: • methods of measurement and characterization of the output of ultrasonic physiotherapy equipment based on reference testing methods; • characteristics to be specified by manufacturers of ultrasonic physiotherapy equipment; • methods of measurement and characterization of the output of ultrasonic physiotherapy equipment based on routine testing methods; • acceptance criteria for aspects of the output of ultrasonic physiotherapy equipment. Therapeutic value and methods of use of ultrasonic physiotherapy equipment are not covered by the scope of this standard. Excluded equipment includes, but is not limited to: • Equipment in which ultrasound waves are intended to destroy conglomerates (for example stones in the kidneys or the bladder) or tissue of any type. • Equipment in which a tool is driven by ultrasound (for example surgical scalpels, phacoemulsifiers, dental scalers or intracorporeal lithotripters). • Equipment in which ultrasound waves are intended to sensitize tissue to further therapies (for example radiation or chemotherapy). • Equipment in which ultrasound waves are intended to treat cancerous (i.e., malignant) or pre-cancerous tissue, or benign masses, such as High Intensity Focused Ultrasound (HIFU) or High Intensity Therapeutic Ultrasound (HITU).
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prEN ISO 22442-2
Identne prEN ISO 22442-2; ISO/DIS 22442-2:2018
Tähtaeg 3.02.2019
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO/DIS 22442-2:2018)
This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO/DIS 22442-1. NOTE 1 Selective sourcing is considered to be especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats. In addition, local safety regulation may be applied to ensure a clean basic handling of animals towards viral and bacterial loads (see also 5.5). The manufacturers should refer to ISO 22442-3 for information on the validation of the elimination and/or inactivation of viruses and TSE agents. This document does not cover the utilization of human tissues in medical devices. This document does not specify a quality management system for the control of all stages of production of medical devices. It is not a requirement of this document to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. The quality management system elements that are required by this document can form a part of a quality management system conforming to ISO 13485. NOTE 2 A general principle for the application of this International Standard is that it is advisable to give due consideration to the requirements and recommendations contained in all three parts of the standard.
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