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Standard · Svensk standard SS-EN ISO 21649:2009

Nålfria injektorer för medicinskt bruk - Krav och provningsmetoder (ISO 21649:2006)

This International Standard applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medi...

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Publicerad

2009-10-21

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Standard · Svensk standard SS-EN ISO 7886-4:2009

Sterila injektionssprutor för engångsbruk - Del 4: Sprutor med skydd mot återanvändning (ISO 7886-4:2006)

This part of ISO 7886 specifies requirements for sterile single-use hypodermic syringes made of plastics materials with or without needle, and intended for the aspiration of fluids or for the injec...

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Publicerad

2009-10-21

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Standard · Svensk standard SS-EN ISO 14889:2009

Ögonoptik - Glasögonglas - Baskrav på råkantade färdiga glasögonglas (ISO 14889:2003)

This International Standard specifies fundamental requirements for uncut finished spectacle lenses. This International Standard is not applicable to protective spectacle lenses. This International ...

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Publicerad

2009-10-13

PDF · 545 SEK
Standard · Svensk standard SS-EN ISO 14534:2009

Ögonoptik - Kontaktlinser och skötselprodukter för kontaktlinser - Baskrav (ISO 14534:2002)

This International Standard specifies safety and performance requirements for contact lenses, contact lens care products and other accessories for contact lenses. This International Standard does n...

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Publicerad

2009-10-13

Upphävd

2011-04-11

PDF · 745 SEK
Standard · Svensk standard SS-EN ISO 10993-13:2009

Biologisk värdering av medicintekniska produkter - Del 13: Identifiering och kvantifiering av nedbrytningsprodukter från polymermaterial (ISO 10993...

This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying andquantifying degradation products from finished polymeric medical devices ready for clinic...

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Publicerad

2009-10-13

Upphävd

2010-06-29

PDF · 745 SEK
Standard · Svensk standard SS-EN ISO 8359:2009

Oxygenkoncentratorer för medicinskt bruk - Säkerhetskrav (ISO 8359:1996)

NOTE 1 See the rationale in annex P.ISO 8359 is one of a series of International Standards based on IEC 601-1. In IEC 601-1 (the "General Standard"), this type of International Standard is referred...

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Publicerad

2009-10-13

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Standard · Svensk standard SS-EN ISO 22794:2009

Tandvård - Implanterbara material för benutfyllnad och benuppbyggnad inom oral och maxillofacial kirurgi - Innehåll i teknisk dokumentation (ISO 22...

This International Standard applies to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting bones in oral and maxillofacial surgery. Produc...

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Publicerad

2009-10-13

PDF · 645 SEK
Standard · Svensk standard SS-EN ISO 7376:2009

Anestesi- och respirationsutrustning - Laryngoskop för trakeal intubation (ISO 7376:2009)

This International Standard gives general requirements for laryngoscopes used for intubation, and specifies critical dimensions for the handle and lamp of hook-on type laryngoscopes. It also addres...

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Publicerad

2009-10-13

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Standard · Svensk standard SS-EN 1282-2:2005+A1:2009

Trakeostomituber - Del 2: Tuber avsedda för barn (ISO 5366-3:2001, modifierad)

This European Standard specifies requirements for paediatric tracheostomy tubes made of plastics materials and/or rubber having inside diameters from 2,0 mm to 6,0 mm. Requirements for paediatric t...

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Publicerad

2009-10-13

PDF · 745 SEK
Standard · Svensk standard SS-EN 1820:2005+A1:2009

Andningsblåsor för anestesisystem (ISO 5362:2000, modifierad)

This European Standard specifies requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems. It includes requirements for ...

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Publicerad

2009-10-13

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Standard · Svensk standard SS-EN 794-3+A2:2009

Lungventilatorer - Del 3: Särskilda krav för ventilatorer avsedda för transporter och nödsituationer

The scope given in clause 1 of EN 60601-1:1990 applies with the following addition: 1.101 R) This part of this European Standard specifies requirements for ventilators, driven by a power source and...

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Publicerad

2009-10-13

PDF · 1.095 SEK
Standard · Svensk standard SS-EN 1782+A1:2009

Trakealtuber och kopplingsstycken

This European Standard specifies requirements for oro-tracheal and naso-tracheal tubes (plain and cuffed) made of plastics materials and/or rubber and requirements for tracheal tube connectors. Spe...

Språk

Publicerad

2009-10-13

PDF · 975 SEK
Standard · Svensk standard SS-EN 13544-1:2007+A1:2009

Utrustning för andningsterapi - Del 1: Nebulisatorer med tillbehör

The scope given in Clause 1 of EN 60601-1:1990 applies except that 1.1 is replaced by the following: 1.1 This European Standard specifies requirements for nebulizing systems used for the delivery o...

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Publicerad

2009-10-13

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Standard · Svensk standard SS-EN 13544-2+A1:2009

Utrustning för andningsterapi - Del 2: Slangar och kopplingar

This part of EN 13544 specifies requirements for tubing to be used with equipment for the therapeutic administration of respirable gases in domiciliary, ambulance and hospital practice including th...

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Publicerad

2009-10-13

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Standard · Svensk standard SS-EN 13544-3+A1:2009

Utrustning för andningsterapi - Del 3: Doseranordningar för andningsoxygen med lufttillblandning

This part of this European Standard specifies minimum performance and safety requirements for air entrainment devices used for delivery of a designated oxygen concentration to patients. It gives a ...

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Publicerad

2009-10-13

PDF · 645 SEK
Standard · Svensk standard SS-EN 12342+A1:2009

Andningsslangar för anestesiapparater och ventilatorer

This European Standard specifies the basic requirements for breathing tubes and breathing tubing supplied to be cut to length, intended for use with anaesthetic apparatus and ventilators, humidifie...

Språk

Publicerad

2009-10-13

PDF · 855 SEK
Standard · Svensk standard SS-EN ISO 8835-3:2009

System för inhalationsanestesi - Del 3: Uppsamlingssystem för aktiv anestesigasevakuering (ISO 8835-3:2007)

This part of ISO 8835 specifies requirements for transfer and receiving systems of active anaesthetic gas scavenging systems (active AGSSs) intended to reduce exposure of healthcare personnel to an...

Språk

Publicerad

2009-10-13

Upphävd

2012-12-17

PDF · 1.330 SEK
Standard · Svensk standard SS-EN 60601-2-19

Elektrisk utrustning för medicinskt bruk - Säkerhet - Del 2-19: Särskilda fordringar på kuvöser

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Språk

Publicerad

2009-10-13

PDF · 1.040 SEK
Standard · Svensk standard SS-EN 60601-2-21

Elektrisk utrustning för medicinskt bruk - Säkerhet - Del 2-21: Särskilda fordringar på strålningsvärmare för barn

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Språk

Publicerad

2009-10-13

PDF · 1.040 SEK
Standard · Svensk standard SS-EN 60601-2-50

Elektrisk utrustning för medicinskt bruk - Säkerhet - Del 2-50: Särskilda fordringar på utrustning för fototerapi för spädbarn

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Språk

Publicerad

2009-10-13

PDF · 1.040 SEK
Standard · Svensk standard SS-EN ISO 10139-2:2009

Tandvård - Mjukförblivande rebaseringsmaterial för avtagbara proteser - Del 2: Material för långtidsbruk (ISO 10139-2:2009)

This part of ISO 10139 specifies requirements for softness, adhesion, water sorption and water solubility as well as for packaging, marking and manufacturer's instructions for soft denture lining m...

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Publicerad

2009-09-23

PDF · 745 SEK
Standard · ISO standard ISO 8612:2009

Ophthalmic instruments - Tonometers

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Publicerad

2009-10-21

PDF · 730 SEK
Standard · ISO standard ISO 80601-2-56:2009

Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temp...

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Språk

Publicerad

2009-10-21

PDF · 1.312 SEK
Standard · IEC standard IEC/TR 62354

General testing procedures for medical electrical equipment

IEC/TR 62354:2009(E) provides guidance on general testing procedures according to IEC 60601-1:1988, IEC 60601-1-1:2000 and IEC 60601-1:2005. This second edition cancels and replaces the first editi...

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Publicerad

2009-10-21

PDF · 2.380 SEK
Standard · IEC standard IEC 60789 Cor 1

Corrigendum 1 - Appareils électromédicaux - Caractéristiques et conditions d'essai des dispositifs d'imagerie par radionucléides - Gamma caméras de...

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Publicerad

2009-10-21

PDF · 0 SEK
Standard · ISO standard ISO 4049:2009

Dentistry - Polymer-based restorative materials

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Publicerad

2009-10-15

PDF · 1.039 SEK
Standard · IEC standard IEC 60601-2-5

Appareils électromédicaux - Partie 2-5: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à ultrasons...

IEC 60601-2-5:2009 applies to the basic safety and essential performance of ultrasonic physiotherapy equipment employing a single plane unfocused circular transducer per treatment head, producing s...

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Publicerad

2009-10-15

PDF · 1.330 SEK
Standard · IEC standard IEC 60601-2-18

Appareils électromédicaux - Partie 2-18: Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'endoscopie

IEC 60601-2-18:2009 establishes particular basic safety and essential performance requirements for endoscopic equipment. The minimum safety requirements specified in this particular standard are co...

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Publicerad

2009-10-15

PDF · 1.610 SEK
Standard · IEC standard IEC 60601-2-41

Appareils électromédicaux - Partie 2-41: Exigences particulières pour la sécurité de base et les performances essentielles des éclairages chirurgic...

IEC 60601-2-41:2009 applies to the basic safety and essential performance of surgical luminaires and luminaires for diagnosis. It amends and supplements IEC 60601-1 (third Edition 2005), hereinafte...

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Publicerad

2009-10-15

PDF · 1.470 SEK
Standard · ISO standard ISO 7176-14:2008

Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods

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Språk

Publicerad

2009-10-13

PDF · 1.380 SEK
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