Medicinsk utrustning

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 27 jul 2019
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This part of ISO 10555 specifies requirements, performance, and user safety issues related to

subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition

and intended for single use.

This part of ISO 10555 does not specify requirements, performance, and user safety issues related to

non-coring needles.

NOTE Subcutaneous implanted ports are known to be used for indications other than intravascular such as

intra-peritoneal, intra-thecal, intra-pleural, and epidural access.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 31 jul 2019
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This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps.

This document does not apply to syringes for use with insulin (specified in ISO 8537[2]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 31 jul 2019
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This part of ISO 7886 specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic or other materials and intended for the filling and the injection of vaccines immediately after filling. Upon commencement of injection of a nominal fixed dose of vaccine, the auto-disable feature of the syringe is passively activated so that the syringe cannot be reused.

This part of ISO 7886 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer.

This part of ISO 7886 is not applicable to syringes for use with insulin (specified in ISO 8537), syringes for use with power-driven syringe pumps (specified in ISO 7886-2), reuse prevention syringes (specified in ISO 7886-4) and syringes designed to be prefilled. It does not address compatibility with injection fluids/vaccines.

NOTE Prefilled syringes are covered under ISO 11040- series.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 6 aug 2019
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This device-specific standard specifies requirements for low flow nasal cannulae, used in both home care and hospital environments for the administration of oxygen therapy.

This document does not include requirements to prevent the proliferation of fire within the tubing but does specify a user-detachable connection that can be used to fit a fire-activated oxygen shut-off device such as that specified in
ISO 19211.

Ämnesområden: Utrustning för ögonoptik
Kommittébeteckning: SIS/TK 336 (Ögonoptik)
Källa: CEN
Svarsdatum: den 14 aug 2019
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This part of ISO 11979 specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.

Ämnesområden: Utrustning för ögonoptik
Kommittébeteckning: SIS/TK 336 (Ögonoptik)
Källa: CEN
Svarsdatum: den 20 aug 2019
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This document specifies a measuring system for spectacle frames and related terminology. It is applicable to spectacle frames with fronts that are intended to be symmetrical.

NOTE Minor asymmetry of only the nasal bearing surfaces has been included in this edition. Since such asymmetry does not affect the lens shapes, only the definition of bridge height is affected, having an amendment in its note 2 to entry.

Ämnesområden: Utrustning för ögonoptik
Kommittébeteckning: SIS/TK 336 (Ögonoptik)
Källa: CEN
Svarsdatum: den 21 aug 2019
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This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to low-vision aids. This document is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.

This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 28 aug 2019
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ISO 18190:2016 Clause 1 is replaced by:

This document specifies minimum performance and safety requirements for air entrainment devices used for delivery of designated oxygen concentrations to patients and includes a test method to check the accuracy of the oxygen concentration in the air/oxygen mixture generated by the air entrainment devices. Air entrainment devices can be a fixed to deliver a single oxygen concentration or adjustable, to deliver a range of oxygen concentration outputs.

It also specifies marking requirements and recommends an optional system of colour coding to assist the user in identifying the designated oxygen concentration.

This document does not cover air entrainment devices which are integral with medical devices specified in other standards e.g. emergency lung ventilators, humidifiers, nebulizers, etc.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 17 sep 2019
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This document specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.