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Uued standardid


EVS-EN ISO 18082:2014/A1:2017
Hind 4,78 EUR
Identne ISO 18082:2014/Amd 1:2017; EN ISO 18082:2014/A1:2017
Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases - Amendment 1 (ISO 18082:2014/Amd 1:2017)
Amendment for EN ISO 18082:2014

EVS-EN ISO 8980-1:2017
Hind 8,72 EUR
Identne ISO 8980-1:2017; EN ISO 8980-1:2017
Ophthalmic optics - Uncut finished spectacle lenses - Part 1: Specifications for single-vision and multifocal lenses ((ISO 8980-1:2017)
ISO 8980-1:2017 specifies requirements and verification methods for the optical and geometrical properties for uncut finished single-vision and multifocal spectacle lenses.

EVS-EN ISO 8980-2:2017
Hind 8,01 EUR
Identne ISO 8980-2:2017; EN ISO 8980-2:2017
Ophthalmic optics - Uncut finished spectacle lenses - Part 2: Specifications for power-variation lenses (ISO 8980-2:2017)
ISO 8980-2:2017 specifies requirements and verification methods for the optical and geometrical properties for uncut finished power-variation lenses.
Asendab EVS-EN ISO 8980-2:2004; EVS-EN ISO 8980-2:2004/AC:2013

EVS-EN ISO 21987:2017
Hind 13,22 EUR
Identne ISO 21987:2017; EN ISO 21987:2017
Oftalmiline optika. Paigaldatud prilliläätsed
ISO 21987:2017 specifies requirements and test methods for mounted spectacle lenses relative to the prescription order.

EVS-EN ISO 22112:2017
Hind 11,67 EUR
Identne ISO 22112:2017; EN ISO 22112:2017
Dentistry - Artificial teeth for dental prostheses (ISO 22112:2017)
ISO 22112:2017 specifies the classification, requirements, and test methods for artificial teeth such as ceramic teeth and polymer teeth that are industrially manufactured for use in dental prostheses.

EVS-EN ISO 6710:2017
Hind 12,51 EUR
Identne ISO 6710:2017; EN ISO 6710:2017
Single-use containers for human venous blood specimen collection (ISO 6710:2017)
ISO 6710:2017 specifies requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers. It does not specify requirements for blood collection needles, needle holders, blood culture receptacles or "arterial" blood gas collection devices that can be used for venous blood.

ISO 10993-11:2017
Hind 128,84 EUR
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
Asendab ISO 10993-11:2006

ISO 15378:2017
Hind 166,18 EUR
Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
ISO 15378:2017 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. NOTE 1 In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards. In ISO 15378:2017 the term "if appropriate" is used several times. When a requirement is qualified by this phrase, it is deemed to be "appropriate" unless the organization can document a justification otherwise. ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.
Asendab ISO 15378:2015

Asendatud või tühistatud standardid


EVS-EN 14820:2004
Identne EN 14820:2004
Ühekordsed katsutid inimese veenivere proovide kogumiseks
This standard specifies requirements and test methods for single-use receptacles, intended by their manufacturer, for the collection of venous blood specimens derived from the human body, for the purposes of in vitro diagnostic examination. This standard also applies to receptacles containing media for blood culture.
Keel: Inglise

EVS-EN ISO 8980-2:2004
Identne ISO 8980-2:2004; EN ISO 8980-2:2004+AC:2006
Oftalmiline optika. Lahtilõikamata viimistletud prilliklaasid. Osa 2: Progresseeruva optilise tugevusega klaaside tehnilised andmed
This part of ISO 8980 specifies requirements for the optical and geometrical properties for uncut finished progressive spectacle lenses.
Keel: Inglise

EVS-EN ISO 8980-1:2004
Identne ISO 8980-1:2004; EN ISO 8980-1:2004+AC:2005+AC:2006
Oftalmiline optika. Lahtilõikamata viimistletud prilliklaasid. Osa 1: Monofokaalsete ja multifokaalsete klaaside tehnilised andmed
Standardi ISO 8980 käesolev osa esitab nõuded lahtilõikamata viimistletud monofokaalsete ja multifokaalsete klaaside optilistele ning geomeetrilistele omadustele.
This part of ISO 8980 specifies requirements for the optical and geometrical properties for uncut finished single-vision and multifocal spectacle lenses.

Keel: Inglise

EVS-EN ISO 22112:2006
Identne ISO 22112:2005; EN ISO 22112:2006
Dentistry - Artificial teeth for dental prostheses
This International Standard specifies the classification, requirements, and test methods for synthetic polymer and ceramic teeth that are manufactured for use in prostheses used in dentistry.
Keel: Inglise

EVS-EN ISO 21987:2009
Identne ISO 21987:2009; EN ISO 21987:2009
Oftalmiline optika. Paigaldatud prilliklaasid
This International Standard specifies requirements for mounted spectacle lenses relative to the prescription order.
Keel: Inglise

Kavandite arvamusküsitlus


prEN ISO 11138-7
Identne ISO/DIS 11138-7; prEN ISO 11138-7
Tähtaeg 18.11.2017
Sterilization of health care products - Biological indicators - Part 7: Self-contained biological indicators for moist heat sterilization (ISO/DIS 11138-7:2017)
This International Standard provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes. 1.1 Exclusions This International Standard does not consider those processes that rely solely on physical removal of microorganisms, e.g., filtration. This International Standard is not intended to apply to combination processes using, for example, washerdisinfectors or flushing and steaming of pipelines. This International Standard does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure. This International Standard is not intended to apply to liquid immersion sterilization processes.
Keel: Inglise

EN ISO 11137-1:2015/prA2
Identne ISO 11137-1:2006/DAmd 2; EN ISO 11137-1:2015/prA2
Tähtaeg 18.11.2017
Tervishoiutoodete steriliseerimine. Kiirgus. Osa 1: Nõuded meditsiiniseadmete steriliseerimisprotsessi väljatöötamisele, valideerimisele ja tavakontrollile
Muudatus standardile EN ISO 11137-1:2015
Amendment for EN ISO 11137-1:2015

Keel: Inglise