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Uued standardid


EVS-EN 16587:2017
Hind 12,51 EUR
Identne EN 16587:2017
Raudteealased rakendused. Piiratud liikumisvõimega isikute kasutatavad rakendused. Nõuded raudteeinfrastruktuuri takistusteta teedele
This European Standard describes the specific ‘Design for PRM Use’ requirements for obstacle-free routes applying to infrastructure and the assessment of those requirements. The following applies to this European Standard: - The definitions and requirements describe specific aspects of ‘Design for PRM Use’ required by persons with disabilities and persons with reduced mobility as defined in the PRM TSI; - This European Standard defines elements which are universally valid for obstacle-free routes. The definitions and requirements of this European Standard should be used for infrastructure applications; - This European Standard only refers to aspects of accessibility for PRM passengers, it does not define general requirements and general definitions; - This European Standard assumes that the infrastructure is in the defined operating condition; - Where minimum or maximum dimensions are quoted these are absolute NOT nominal requirements. This European Standard contains requirements relating to 'Obstacle-free routes'.

EVS-EN ISO 80369-7:2017
Hind 18,00 EUR
Identne ISO 80369-7:2016; EN ISO 80369-7:2017
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016)
ISO 80369-7:2016 specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories. EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female luer slip connectors and luer lock connectors. NOTE 1 Hypodermic use includes percutaneous infusion and injection as well as pressurizing and depressurizing the retention mechanisms (e.g. balloon) used to hold invasive medical devices in place and endoscopic devices. NOTE 2 The luer connector was originally designed for use at pressures up to 300 kPa. ISO 80369-7:2016 does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. This part of ISO 80369 does not specify requirements for the following small-bore connectors, which are specified in other International Standards: - haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 and applicable portion of ISO 8638 referencing blood compartment ports); - haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637); - infusion system closure piercing connectors (ISO 8536‑4). NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 into medical devices 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, requirements for small-bore connectors, as specified in ISO 80369, will be included. NOTE 4 ISO 80369‑1:2010, 5.8, specifies alternative methods of compliance with ISO 80369‑1:2010, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not comply with this part of ISO 80369.

EVS-EN ISO 10939:2017
Hind 7,38 EUR
Identne ISO 10939:2017; EN ISO 10939:2017
Ophthalmic instruments - Slit-lamp microscopes (ISO 10939:2017)
ISO 10939:2017, together with ISO 15004‑1 and ISO 15004‑2, specifies requirements and test methods for slit-lamp microscopes to provide slit illumination and observation under magnification of the eye and its adnexa. ISO 10939:2017 is not applicable to microscope accessories, e.g. photographic equipment and lasers. ISO 10939:2017 takes precedence over ISO 15004‑1 and ISO 15004‑2, if differences exist.

ISO 11491:2017
Hind 54,15 EUR
Implants for surgery -- Determination of impact resistance of ceramic femoral heads for hip joint prostheses
ISO 11491:2017 specifies two alternative test methods for determining the impact resistance of ceramic femoral heads for hip joint prostheses.

IEC 60601-2-75:2017
Hind 158,72 EUR
Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
IEC 60601-2-75:2017 applies to the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.
This document applies to photodynamic therapy and photodynamic diagnosis equipment used for compensation or alleviation of disease, injury or disability.
In the case of combined equipment (e.g. equipment additionally provided with a function or an applied part for the target area), such equipment also comply with any particular standard specifying safety requirements for the additional function.
This particular standard does not apply to:
- light therapy equipment intended for use in photothermal ablation, coagulation, and hyperthermia;
- low-level laser therapy equipment not intended for use with a photosensitizer;
- illumination equipment intended for use in observation, monitoring, and diagnosis, not intended for use with a photosensitizer.
This document is to be used with IEC 60601-1:2005 and its amendment 1.


IEC 60601-2-43:2010/AMD1:2017
Hind 37,34 EUR
Amendment 1 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures


IEC 60601-2-43:2010+AMD1:2017 CSV
Hind 373,45 EUR
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
IEC 60601-2-43:2010+A1:2017 establishes particular basic safety and essential performance requirements for the design and manufacture of X ray equipment for radioscopically guided interventional procedures. It specifies information which is to be provided with such interventional X-ray equipment for the assistance of the responsible organization and operator in managing the radiation risk and equipment failure risk arising from these procedures which could affect patients or staff. This second edition cancels and replaces the first edition published in 2000. This particular standard has been revised to provide a complete set of safety requirements for X-ray equipment for radioscopically guided interventional procedures, based on the third edition of IEC 60601-1 and relevant collaterals. The present edition is extended to become a system standard for X-ray equipment designed for the use during interventional procedures using X-ray imaging, whether of prolonged or normal duration. This consolidated version consists of the second edition (2010) and its amendment 1 (2017). Therefore, no need to order amendment in addition to this publication.

Asendatud või tühistatud standardid


EVS-EN 1707:1999
Identne EN 1707:1996
6% koonilisusega (Luer) koonilised vahelülid süstaldele, nõeltele ja teatud muule meditsiinivarustusele. Lukustuvad vahelülid
Standard esitab nõuded 6% koonilisusega (Luer) koonilistele lukustuvatele vahelülidele, mis on ette nähtud kasutamiseks koos nahaalusteks süsteteks ettenähtud süstalde ja nõeltega ning teatud muude meditsiiniliselt kasutatavate seadmetega, nt. transfusiooniseadmestikuga. Nõuded kehtivad jäikadest ja pooljäikadest materjalidest valmistatud vahelülide kohta ning sisaldavad testimismeetodeid.
This European Standard specifies requirements for conical lock fittings with a 6 % (Luer) taper for use with hypodermic syringes and needles and with certain other apparatus for medical use e.g. transfusion equipment. The requirements apply to fittings made of rigid and of semi-rigid materials and include test methods, but exclude provision for more flexible or elastomeric materials. NOTE 1. It is not practicable to define the characteristics of rigid or semi-rigid materials with precision, but glass and metal may be considered as typical rigid materials. In contrast many plastics materials may be regarded as semi-rigid. NOTE 2. The Luer lock fitting was designed for use at pressures of the order of 300 kPa or lower. Its use in other applications may require consideration to establish its suitability.

Keel: Inglise

EVS-EN 20594-1:1999
Identne ISO 594-1:1986; EN 20594-1:1993; EN 20594-1:1993/AC:1996; EN 20594-1:1993/A1:1997
6% koonilisusega (Luer) koonilised vahelülid süstaldele, nõeltele ja teatud muule meditsiinivarustusele. Osa 1: Üldnõuded
Standardi käesolev osa esitab nõuded 6% koonilisusega (Luer) koonilistele vahelülidele, mis on ette nähtud kasutamiseks koos nahaalusteks süsteteks ettenähtud süstalde ja nõeltega ning teatud muude meditsiiniliselt kasutatavate seadmetega, sellistega nagu transfusiooni- ja infusiooniseadmed.
Specification of the requirements for conical (Luer) fittings for use with hyperdemic syringes and needles and with certain other apparatus for medical use such as transfusion and infusion sets. It covers fittings made of rigid and semi-rigid materials and includes test methods for gauging and performance. It excludes provision for more flexible or elastomeric materials. The annex on liquid leakage is given as an example.

Keel: Inglise

EVS-EN ISO 10939:2007
Identne ISO 10939:2007; EN ISO 10939:2007
Oftalmilised instrumendid. Pilulampmikroskoobid
Käesolev rahvusvaheline standard koos standardiga ISO 15004 esitab nõuded ja testimismeetodid pilulampmikroskoopidele, et tagada silma ja silmamanuste piluvalgustus ning vaatlus suurenduse all. See rahvusvaheline standard ei kehti mikroskoobi lisaseadmete kohta, n.t. fotografeerimisseadmete ja laserite kohta.
This International Standard, together with ISO 15004-1 and ISO 15004-2, specifies requirements and test methods for slit-lamp microscopes to provide slit illumination and observation under magnification of the eye and its adnexa. This International Standard is not applicable to microscope accessories, e.g. photographic equipment and lasers. This International Standard takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.

Keel: Inglise

Kavandite arvamusküsitlus


prEN 13795-1
Identne prEN 13795-1
Tähtaeg 16.08.2017
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of surgical drapes and gowns and sets performance requirements for these products. EN 13795-1 does not cover requirements for resistance to penetration by laser radiation of products. Suitable test methods for resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810. EN 13795-1 does not cover requirements for incise drapes or films. EN 13795-1 does not cover requirements for antimicrobial treatments for surgical gowns and drapes. Antimicrobial treatment may cause environmental risks such as resistance and pollution. However, antimicrobial treated surgical gowns and drapes fall under the scope of this standard with respect to their use as surgical gowns and drapes.
Keel: Inglise

prEN 13795-2
Identne prEN 13795-2
Tähtaeg 16.08.2017
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable clean air suits used as medical devices for clinical staff, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products.
Keel: Inglise