11 TERVISEHOOLDUS

Tagasi peagrupi juurde

Uued standardid

EVS-EN 60601-1-8:2007/A1:2013
Hind 13,22 EUR
Elektrilised meditsiiniseadmed. Osa 1-8: Üldnõuded esmasele ohutusele ja seadmeomasele toimivusele. Kollateraalstandard: Elektrilistes meditsiiniseadmetes ja -süsteemides kasutatavatele häiresüsteemidele esitatavad üldnõuded, katsetamine ja juhised
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS. It also provides guidance for the application of ALARM SYSTEMS.

EVS-EN 62127-2:2007/A1:2013
Hind 12,51 EUR
Ultrasonics - Hydrophones - Part 2: Calibration for ultrasonic fields up to 40 MHz (IEC 62127-2:2007/A1:2013)
This part of IEC 62127 specifies: - absolute hydrophone calibration methods; - relative (comparative) hydrophone calibration methods. This standard is applicable to - hydrophones used for measurements made in water and in the ultrasonic frequency range up to 40 MHz; - hydrophones employing circular piezoelectric sensor elements, designed to measure the pulsed wave and continuous wave ultrasonic fields generated by ultrasonic equipment; - hydrophones with or without a hydrophone pre-amplifier. IEC 62127-1, IEC 62127-2 and IEC 62127-3 are being published simultaneously. Together these cancel and replace IEC 60866:1987, IEC 61101:1991, IEC 61102:1991, IEC 61220:1993 and IEC 62092:2001. The contents of the corrigendum of August 2008 have been included in this copy.

EVS-EN 61157:2007/A1:2013
Hind 7,38 EUR
Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment (IEC 61157:2007/A1:2013)
This International Standard is applicable to medical diagnostic ultrasonic equipment. - It provide a set of traceable acoustic parameters describing the acoustic fields - It defines a standard means and format for the reporting of the acoustic output information. - It also describes a reduced dataset recommended for equipment generating low acoustic output levels.

EVS 917:2013
Hind 8,01 EUR
Meditsiinilised survesukad
See standard kehtestab nõuded survesukkadele, mida kasutatakse jalaveenide ja lümfisoonte haiguste puhul ja mis on valmistatud looduslikest ja sünteetilistest niitidest kombinatsioonis kõrgelastsete niitidega. Standardi nõuded ei kehti profülaktilistele survesukkadele.
This standard specifies requirements for medical compression hosiery, which is used for the treatment of venous and/or lymphatic diseases of the leg and knitted from threads made of natural fibres or synthetic fibres and elastic threads. Standard does not deal with preventive compression hosiery

EVS-EN 62127-1:2007/A1:2013
Hind 10,90 EUR
Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz (IEC 62127-1:2007/A1:2013)
This part of IEC 62127 specifies methods of use of calibrated hydrophones for the measurement in liquids of acoustic fields generated by ultrasonic medical equipment operating in the frequency range up to 40 MHz. The objectives of this standard are: – to define a group of acoustic parameters that can be measured on a physically sound basis; – to define a second group of parameters that can be derived under certain assumptions from these measurements, and called derived intensity parameters; – to define a measurement procedure that may be used for the determination of acoustic pressure parameters; – to define the conditions under which the measurements of acoustic parameters can be made in the frequency range up to 40 MHz using calibrated hydrophones; – to define procedures for correcting, for limitations caused by the use of hydrophones with finite bandwidth and finite active element size. NOTE 1 Throughout this standard, SI units are used. In the specification of certain parameters, such as beam areas and intensities, it may be convenient to use decimal multiples or submultiples. For example beam area may be specified in cm2 and intensities in W/cm2 or mW/cm2. NOTE 2 The hydrophone as defined may be of a piezoelectric or an optic type.

ISO 8637:2010/Amd 1:2013
Hind 13,23 EUR
Revision to Figure 2 -- Main fitting dimensions of dialysis fluid inlet and outlet ports


ISO 6873:2013
Hind 81,06 EUR
Dentistry -- Gypsum products


ISO 5841-3:2013
Hind 61,21 EUR
Implants for surgery -- Cardiac pacemakers -- Part 3: Low-profile connectors (IS-1) for implantable pacemakers


ISO 13408-1:2008/Amd 1:2013
Hind 13,23 EUR
Aseptic processing of health care products — Part 1: General requirements AMENDMENT 1


ISO 81060-2:2013
Hind 120,76 EUR
Non-invasive sphygmomanometers -- Part 2: Clinical investigation of automated measurement type


ISO 3630-2:2013
Hind 71,13 EUR
Dentistry -- Endodontic instruments -- Part 2: Enlargers


ISO/TS 17665-3:2013
Hind 134,00 EUR
Sterilization of health care products -- Moist heat -- Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization


EVS-EN ISO 6873:2013
Hind 11,67 EUR
Dentistry - Gypsum products (ISO 6873:2013)
This International Standard gives a classification of, and specifies requirements for, gypsum products used for dental purposes such as making oral impressions, moulds, casts, dies or model bases, and mounting models. It specifies the test methods to be employed to determine compliance with these requirements. It also includes requirements for the labelling of packaging and for adequate instructions to accompany each package. This International Standard does not apply to dental bone graft substitutes composed of calcium sulphate hemihydrate (or gypsum).

Asendatud või tühistatud standardid

EVS-EN 12376:2001
In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
This standard specifies requirements for information supplied by the manufacturer with reagents used in staining in biology.
Keel: Inglise

EVS-EN ISO 6873:2000
Dental gypsum products
The standard gives a classification of, and specifies requirements for, gypsum products used for dental purposes such as for making oral impressions, models, casts or dies. It also specifies the test methods to be employed to determine compliance with these requirements.
Keel: Inglise

ISO 5841-3:2000/Cor 1:2003
Implants for surgery -- Cardiac pacemakers -- Part 3: Low-profile connectors (IS-1) for implantable pacemakers

Keel: Inglise

ISO 6873:1998
Dental gypsum products

Keel: Inglise

ISO 5841-3:2000
Implants for surgery -- Cardiac pacemakers -- Part 3: Low-profile connectors (IS-1) for implantable pacemakers

Keel: Inglise

ISO 81060-2:2009
Non-invasive sphygmomanometers -- Part 2: Clinical validation of automated measurement type

Keel: Inglise

ISO 3630-2:2000
Dental root-canal instruments -- Part 2: Enlargers

Keel: Inglise

ISO 81060-2:2009/Cor 1:2011
Non-invasive sphygmomanometers — Part 2: Clinical validation of automated measurement type

Keel: Inglise

Kavandite arvamusküsitlus

prEN ISO 11197
Tähtaeg 30.06.2013
Meditsiinilised toiteseadmed (ISO/DIS 11197:2013)
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, hereafter also referred to as ME EQUIPMENT. This International Standard applies to MEDICAL SUPPLY UNITS manufactured within a factory or assembled on site. NOTE The definition of a MANUFACTURER and guidance on assembly on site can be found in ISO 14971 and ISO 13485. HAZARDS inherent in the intended function of ME EQUIPMENT or ME SYSTEMS within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the General Standard.
Keel: Inglise

FprEN 80601-2-58
Tähtaeg 30.06.2013
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery - Proposed Horizontal Standards
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.208 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard.
Keel: Inglise

prEN ISO 11979-6
Tähtaeg 30.06.2013
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO/DIS 11979-6:2013)
This part of ISO 11979 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the stability of IOLs in distribution and storage.
Keel: Inglise

prEN ISO 13212
Tähtaeg 30.06.2013
Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO/DIS 13212:2013)
This International Standard provides guidance on the design of stability studies for use in gathering information to enable determination of the shelf-life of contact lens care products. This International Standard does not address studies designed to obtain information to establish the in-use stability (i.e. notice of discard date) of contact lens care products.
Keel: Inglise

prEN ISO 7494-2
Tähtaeg 30.06.2013
Dentistry - Dental units - Part 2: Media channels and connections (ISO/DIS 7494-2:2013)
This part of ISO 7494 specifies requirements and test methods concerning: a) The configuration of dental unit connections to the compressed air supply, water supply, suction supply and waste water drain plumbing. b) The materials, design and construction of the compressed air and water supply within the dental unit. c) The quality for incoming water and air. d) The performance of dental unit suction devices in a dental unit. This part of ISO 7494 also specifies requirements for instructions for use, marking, packaging and technical description that is to be provided by the manufacturer. This part of ISO 7494 is limited to dental units that are not used for life support treatment of ambulatory patients or for oral surgery treatment requiring sterile air and water supplies. Amalgam separators are not included in this Standard.
Keel: Inglise

prEN ISO 11978
Tähtaeg 30.06.2013
Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO/DIS 11978:2013)
This International Standard specifies the information to be provided by the manufacturer of contact lenses and contact lens care products to ensure the correct and safe use of these devices and their accessories by both types of users of contact lenses: the eye care professional and the contact lens wearer. This International Standard does not specify the format in which such information shall be provided.
Keel: Inglise

prEN ISO 11499
Tähtaeg 30.06.2013
Hambaravis kohaliku tuimastuse jaoks kasutatavad ampullid
This International Standard gives specific performance requirements for single-use dental cartridges of 1,0 ml, 1.7 ml, 1,8 ml and 2,2 ml nominal capacity for use with local anaesthetics. It specifies tests for leakage, plunger movement, extractable volume and underfilling, and lists general overall dimensions to ensure that the cartridge will fit dental cartridge syringes complying with ISO 9997 and ISO 21533. Labelling requirements are also specified. NOTE A list of International Standards for certain types of cartridge component is given in the Bibliography.
Keel: Inglise