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Standard · Svensk standard SS-EN 16586-1:2017

Järnvägar - Utformning för personer med funktionsnedsättning - Tillgänglighet till fordonen för personer med rörelsehinder - Del 1: Trappsteg för p...

This European Standard describes the specific ‘Design for PRM use’ requirements applying to rolling stock and the assessment of those requirements. The following applies to this standard: -The defi...

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Publicerad

2017-04-27

PDF · 785 SEK
Standard · Svensk standard SS-EN 16586-2:2017

Järnvägar - Utformning för personer med funktionsnedsättning - Tillgänglighet till fordonen för personer med rörelsehinder - Del 2: Hjälpmedel för ...

This European Standard describes the specific ‘Design for PRM use’ requirements applying to rolling stock and the assessment of those requirements. The following applies to this standard: -the defi...

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Publicerad

2017-04-27

PDF · 895 SEK
Standard · ISO standard ISO 9873:2017

Dentistry -- Intra-oral mirrors

ISO 9873:2017 specifies requirements and test methods for reusable intra-oral mirrors with a coated glass reflecting surface used for dental purposes in the oral cavity. In addition, specific requi...

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Publicerad

2017-04-26

PDF · 529 SEK
Standard · Utländsk standard DIN 13990

Dentistry - Test methods for shear bond strength of adhesives for orthodontic attachments

The test is carried out as a test of the total bonding between attachment, adhesive and enamel. This test of the total bonding is added by a bonding test between attachment and adhesive and between...

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Publicerad

2017-04-26

PDF · 832 SEK
Standard · Svensk standard SS-EN ISO 11138-3:2017

Sterilisering av medicintekniska produkter - Biologiska indikatorer - Del 3: Biologiska indikatorer för steriliseringsprocesser med fuktig värme (I...

ISO 11138-3:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization p...

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Publicerad

2017-04-25

PDF · 575 SEK
Standard · Svensk standard SS-EN 80369-5

Finkalibriga kopplingar för vätskor och gaser inom hälso- och sjukvård - Del 5: Kopplingar för manschetter

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Publicerad

2017-04-24

PDF · 889 SEK
Standard · ISO standard ISO 10993-4:2017

Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood

ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in co...

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Publicerad

2017-04-21

PDF · 1.517 SEK
Standard · ISO standard ISO 11979-8:2017

Ophthalmic implants -- Intraocular lenses -- Part 8: Fundamental requirements

ISO 11979-8:2017 specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and...

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Publicerad

2017-04-21

PDF · 347 SEK
Standard · ISO standard ISO 19610:2017

Traditional Chinese medicine -- General requirements for industrial manufacturing process of red ginseng (Panax ginseng C.A. Meyer)

This document specifies the general requirements for the industrial manufacturing process of red ginseng from Panax ginseng C.A. Meyer which is the only species from which red ginseng is processed[...

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Publicerad

2017-04-21

PDF · 529 SEK
Standard · ISO standard ISO 14708-3:2017

Implants for surgery -- Active implantable medical devices -- Part 3: Implantable neurostimulators

ISO 14708-3:2017 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system. The tests that are specified in this document a...

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Publicerad

2017-04-21

PDF · 1.517 SEK
Standard · Svensk standard SS-ISO 15223-2:2017

Medicintekniska produkter - Symboler att användas vid märkning av produkt och information till användare - Del 2: framtagning, urval och validering...

This part of ISO 15223 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1. The purpose of this part of ISO 15223 is to ensure that symbols included i...

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Publicerad

2017-04-20

PDF · 785 SEK
Standard · Svensk standard SS-EN ISO 11138-2:2017

Sterilisering av medicintekniska produkter - Biologiska indikatorer - Del 2: Biologiska indikatorer för steriliseringsprocesser med etylenoxid (ISO...

ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and...

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Publicerad

2017-04-13

PDF · 575 SEK
Standard · Svensk standard SS-EN ISO 11138-4:2017

Sterilisering av medicintekniska produkter - Biologiska indikatorer - Del 4: Biologiska indikatorer för steriliseringsprocesser med torr värme (ISO...

This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization proc...

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Publicerad

2017-04-12

PDF · 575 SEK
Standard · Svensk standard SS-EN ISO 11138-1:2017

Sterilisering av medicintekniska produkter - Biologiska indikatorer- Del 1: Allmänna krav (ISO 11138-1:2017)

This document specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and the...

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Publicerad

2017-04-12

PDF · 1.155 SEK
Standard · Svensk standard SS-EN ISO 11138-5:2017

Sterilisering av medicintekniska produkter - Biologiska indikatorer - Del 5: Biologiska indikatorer för steriliseringsprocesser med lågtemperaturån...

ISO 11138-5:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization p...

Språk

Publicerad

2017-04-12

PDF · 575 SEK
Standard · Teknisk specifikation SIS-ISO/TS 20746:2017

Tandvård - Bestämmande av hållfasthet för dentalt amalgam enligt Hertzianmetoden (HIT)

This document gives the practical details of the test method for the measurement of the strength of a dental amalgam by the Hertzian indentation strength test (HIT) method. It is applicable to dent...

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Publicerad

2017-04-11

PDF · 575 SEK
Standard · IEC standard IEC 60601-2-2:2017

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipmen...

NEW!IEC 60601-2-2:2017 is available as IEC 60601-2-2:2017 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previou...

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Publicerad

2017-04-03

PDF · 560 SEK
Standard · Svensk standard SS-ISO 16142-1:2017

Erkända grundläggande principer för säkerhet och prestanda för medicintekniska produkter - Del 1: Allmänna grundläggande principer och ytterligare ...

ISO 16142:2016, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device t...

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Publicerad

2017-03-29

PDF · 1.155 SEK
Standard · Svensk standard SS-EN ISO 25539-1:2017

Kardiovaskulära implantat - Endovaskulära produkter - Del 1: Endovaskulära proteser (ISO 25539-1:2017)

ISO 25539-1:2017 specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information...

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Publicerad

2017-03-24

PDF · 575 SEK
Standard · Utländsk standard DIN 58948-7

Sterilization - Low temperature sterilizers - Part 7: Requirements for the installation and operation of ethylene oxide sterilizers and their suppl...

NOTE 1 For the requirements of fully automated EO sterilizers, see Technical Rules for Hazardous Substances (TRGS 513). NOTE 2 Although the scope of this standard is limited to medical devices, it...

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Publicerad

2017-03-22

PDF · 966 SEK
Standard · ISO standard ISO/ASTM 51939:2017

Practice for blood irradiation dosimetry

1.1 This practice outlines the irradiator installation qualifi-cation program and the dosimetric procedures to be followed during operational qualification and performance qualifi...

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Publicerad

2017-03-20

PDF · 803 SEK
Standard · ISO standard ISO 18562-3:2017

Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 3: Tests for emissions of volatile organic compounds (VOCs)

ISO 18562-3:2017 specifies tests for the emissions of volatile organic compounds (vocs) from the gas pathways of a medical device, its parts or accessories, which are intended to provide respirator...

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Publicerad

2017-03-20

PDF · 529 SEK
Standard · ISO standard ISO 18668-2:2017

Traditional Chinese medicine -- Coding system for Chinese medicines -- Part 2: Codes for decoction pieces

ISO 18668-2:2017 encodes 828 kinds of decoction pieces, according to the rules in ISO 18668-1. This document is suitable for coding of decoction pieces, as well as decoction pieces in the fields of...

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Publicerad

2017-03-20

PDF · 1.517 SEK
Standard · ISO standard ISO 18562-1:2017

Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 1: Evaluation and testing within a risk management process

ISO 18562-1:2017 specifies: - the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories, whi...

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Publicerad

2017-03-20

PDF · 1.005 SEK
Standard · ISO standard ISO 18562-4:2017

Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 4: Tests for leachables in condensate

ISO 18562-4:2017 specifies tests for substances leached by liquid water condensing into gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or...

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Publicerad

2017-03-20

PDF · 529 SEK
Standard · ISO standard ISO 80601-2-56:2017

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

ISO 80601-2-56:2017 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, hereafter referred to as me equipment. This document specifi...

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Publicerad

2017-03-20

PDF · 1.346 SEK
Standard · ISO standard ISO/TR 13154:2017

Medical electrical equipment -- Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph

ISO/TR 13154:2017 provides general guidelines for the deployment, implementation and operation of a screening thermograph intended to be used for non-invasive febrile temperature screening of indiv...

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Publicerad

2017-03-20

PDF · 1.005 SEK
Standard · ISO standard ISO 20749:2017

Dentistry -- Pre-capsulated dental amalgam

ISO 20749:2017 specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy and dental mercury in quantities suitabl...

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Publicerad

2017-03-20

PDF · 1.176 SEK
Standard · ISO standard ISO 18668-3:2017

Traditional Chinese medicine -- Coding system for Chinese medicines -- Part 3: Codes for Chinese Materia Medica

ISO 18668-3:2017 encodes 592 kinds of Chinese Materia Medica, according to the rules in ISO 18668-1. ISO 18668-3:2017 is suitable for coding of Chinese Materia Medica, as well as Chinese Materia Me...

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Publicerad

2017-03-20

PDF · 1.517 SEK
Standard · ISO standard ISO 18562-2:2017

Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 2: Tests for emissions of particulate matter

ISO 18562-2:2017 specifies tests for the emissions of particulate matter from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or suppl...

Språk

Publicerad

2017-03-20

PDF · 803 SEK
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