Hälso- och sjukvård

Ämnesområden:
Kommittébeteckning: SIS/TK 331 (Laboratoriemedicin)
Källa: CEN
Svarsdatum: den 16 okt 2021
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This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This document does not address language requirements since that is the domain of national laws and regulations.
This document does not apply to:
a) IVD medical devices for performance evaluation (e.g. for investigational use only);
b) packaging list;
c) material safety data sheets / Safety Data Sheets;
d) marketing information (consistent with applicable legal requirements).

Ämnesområden:
Kommittébeteckning: SIS/TK 331 (Laboratoriemedicin)
Källa: CEN
Svarsdatum: den 16 okt 2021
Se merSe mindre
 

This document specifies requirements for information supplied by the manufacturer of IVD reagents, calibrators and controls intended for professional use.
This document can also be applied to accessories.
This document applies to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for self-testing.

Ämnesområden:
Kommittébeteckning: SIS/TK 331 (Laboratoriemedicin)
Källa: CEN
Svarsdatum: den 16 okt 2021
Se merSe mindre
 

This document specifies requirements for information supplied by the manufacturer of IVD instruments intended for professional use.
This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
This document can also be applied to accessories.
This document does not apply to:
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for self-testing.

Ämnesområden:
Kommittébeteckning: SIS/TK 331 (Laboratoriemedicin)
Källa: CEN
Svarsdatum: den 16 okt 2021
Se merSe mindre
 

This document specifies requirements for information supplied by the manufacturer of IVD reagents, calibrators, and controls intended for self-testing.
This document can also be applied to accessories.
This document applies to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for professional use.

Ämnesområden:
Kommittébeteckning: SIS/TK 331 (Laboratoriemedicin)
Källa: CEN
Svarsdatum: den 16 okt 2021
Se merSe mindre
 

This document specifies requirements for information supplied by the manufacturer of IVD instruments intended for self-testing.
This document also applies to apparatus and equipment intended to be used with in vitro diagnostic (IVD) instruments for self-testing.
This document can also be applied to accessories.
This document does not apply to
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for professional use.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 17 okt 2021
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This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment:

- intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;

- intended to be operated by a healthcare professional operator; and

- intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.

Ämnesområden: Tandvårdsmaterial
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: ISO
Svarsdatum: den 20 okt 2021
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This document specifies requirements and test methods for dental brazing materials suitable for use in metallic restorations. Excluded are brazing materials with silver as main component.

Kommittébeteckning: SIS/TK 340 (Biologisk säkerhet för medicintekniska produkter)
Källa: CEN
Svarsdatum: den 30 okt 2021
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This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following:
— the identification of its materials of construction (medical device configuration);
— the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition);
— the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues);
— the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables);
— the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).
This document can also be used for chemical characterization (e.g. the identification and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).
This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.

Kommittébeteckning: SIS/TK 504 (e-Tillgänglighet)
Källa: ISO
Svarsdatum: den 20 dec 2021
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This document provides guidance on the mapping of the set of user accessibility needs with the provisions of a particular standard, technical report, or set of guidelines. It provides both basic guidance that should be used for all user accessibility needs mapping and optional guidance that may be added to the basic guidance.
User accessibility need mapping is intended to help improve accessibility for all users and in particular for users with special needs that might otherwise be overlooked. User Accessibility Need Mapping is not intended to be used to evaluate, certify, or otherwise judge a given standard or set of guidelines.