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SS 872805:2012
Standard · Svensk standard SS 872805:2012

Laboratoriemedicin - Färgkoder för säkerhetskork på vakuumrör för provtagning av venöst blod

Denna svenska standard anger krav på färgkoder för säkerhetskorken på vakuumrör för engångsbruk som används vid provtagning av venöst blod som tas från människor.Färgkodningen omfattar de vanligast...

Språk

Publicerad

2012-02-21
PDF · 435 SEK
SS-EN ISO 16256:2012
Standard · Svensk standard SS-EN ISO 16256:2012

In vitro diagnostik - Laboratoriemedicin och system för in vitro-diagnostiska undersökningar - Referensmetod för provning av in vitro-aktiviteten h...

ISO 16256:2012 describes a method for testing the susceptibility to antifungal agents of yeasts, including Candida spp. and Cryptococcus neoformans, that cause infections. The reference method desc...

Språk

Publicerad

2012-12-27
PDF · 745 SEK
SS-EN ISO 10993-14:2009
Standard · Svensk standard SS-EN ISO 10993-14:2009

Biologisk värdering av medicintekniska produkter - Del 14: Identifiering och kvantifiering av nedbrytningsprodukter från keramiska material (ISO 10...

This part of ISO 10993 specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the analy...

Språk

Publicerad

2009-06-09
PDF · 745 SEK
SS-EN ISO 10993-12:2012
Standard · Svensk standard SS-EN ISO 10993-12:2012

Biologisk värdering av medicintekniska produkter - Del 12: Provberedning och referensmaterial (ISO 10993-12:2012)

ISO 10993-12:2012 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in bio...

Språk

Publicerad

2012-08-16
PDF · 855 SEK
SS-EN ISO 19001:2013
Standard · Svensk standard SS-EN ISO 19001:2013

In vitro diagnostik - Information som ska tillhandahållas av tillverkaren av in vitro-diagnostiska reagens för färgning av biologiska material (ISO...

ISO 19001:2013 specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers and vendors of dyes, stains, chromog...

Språk

Publicerad

2013-03-28
PDF · 645 SEK
SIS-CEN ISO/TS 22367:2010
Standard · Teknisk specifikation SIS-CEN ISO/TS 22367:2010

Kliniska laboratorier - Reducering av fel genom riskhantering och ständig förbättring (ISO/TS 22367:2008, inklusive Cor 1:2009)

This Technical Specification characterizes the application of ISO 15189 as a system for reducing laboratory error and improving patient safety by applying the principles of risk management, with re...

Språk

Publicerad

2010-03-10
PDF · 645 SEK
ISO 15193:2009
Standard · ISO standard ISO 15193:2009

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of refe...

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Språk

Publicerad

2009-06-11
PDF · 835 SEK
ISO 15194:2009
Standard · ISO standard ISO 15194:2009

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials an...

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Språk

Publicerad

2009-06-11
PDF · 733 SEK
ISO 10993-7:2008
Standard · ISO standard ISO 10993-7:2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

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Språk

Publicerad

2008-11-06
PDF · 1.670 SEK
ISO 22442-1:2007
Standard · ISO standard ISO 22442-1:2007

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management

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Språk

Publicerad

2008-01-09
PDF · 988 SEK
ISO 22442-2:2007
Standard · ISO standard ISO 22442-2:2007

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling

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Språk

Publicerad

2008-01-09
PDF · 733 SEK
ISO 22442-3:2007
Standard · ISO standard ISO 22442-3:2007

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmiss...

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Språk

Publicerad

2008-01-09
PDF · 920 SEK
ISO 10993-18:2005
Standard · ISO standard ISO 10993-18:2005

Biological evaluation of medical devices - Part 18: Chemical characterization of materials

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Språk

Publicerad

2005-09-07
PDF · 784 SEK
ISO/TR 18112:2006
Standard · ISO standard ISO/TR 18112:2006

Clinical laboratory testing and in vitro diagnostic test systems - In vitro diagnostic medical devices for professional use - Summary of regulatory...

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Språk

Publicerad

2006-03-15
PDF · 1.789 SEK
ISO/TS 10993-19:2006
Standard · ISO standard ISO/TS 10993-19:2006

Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials

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Språk

Publicerad

2006-06-09
PDF · 733 SEK
ISO 10993-10:2002/Amd 1:2006
Standard · ISO standard ISO 10993-10:2002/Amd 1:2006

ISO 10993-10:2002/Amd 1:2006

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Språk

Publicerad

2006-08-09
PDF · 315 SEK
ISO 10993-2:2006
Standard · ISO standard ISO 10993-2:2006

Biological evaluation of medical devices - Part 2: Animal welfare requirements

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Språk

Publicerad

2006-08-09
PDF · 730 SEK
ISO 10993-6:2007
Standard · ISO standard ISO 10993-6:2007

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

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Språk

Publicerad

2007-04-19
PDF · 920 SEK
ISO 17593:2007
Standard · ISO standard ISO 17593:2007

Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

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Språk

Publicerad

2007-05-09
PDF · 1.380 SEK
ISO 20776-1:2006
Standard · ISO standard ISO 20776-1:2006

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of ant...

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Språk

Publicerad

2006-12-06
PDF · 835 SEK
ISO 20776-2:2007
Standard · ISO standard ISO 20776-2:2007

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of ant...

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Språk

Publicerad

2007-06-21
PDF · 603 SEK
ISO/TS 10993-20:2006
Standard · ISO standard ISO/TS 10993-20:2006

Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices

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Språk

Publicerad

2006-09-06
PDF · 784 SEK
ISO/TS 20993:2006
Standard · ISO standard ISO/TS 20993:2006

Biological evaluation of medical devices - Guidance on a risk-management process

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Språk

Publicerad

2006-09-06

Upphävd

2012-10-08
PDF · 402 SEK
ISO 10993-11:2006
Standard · ISO standard ISO 10993-11:2006

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

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Språk

Publicerad

2006-09-06
PDF · 988 SEK
ISO 10993-5:2009
Standard · ISO standard ISO 10993-5:2009

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

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Språk

Publicerad

2009-06-11
PDF · 1.142 SEK
ISO 10993-1:2009
Standard · ISO standard ISO 10993-1:2009

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

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Språk

Publicerad

2009-11-12
PDF · 920 SEK
ISO 10993-7:2008/Cor 1:2009
Standard · ISO standard ISO 10993-7:2008/Cor 1:2009

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

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Språk

Publicerad

2009-11-18
PDF · 0 SEK
ISO 10993-9:2009
Standard · ISO standard ISO 10993-9:2009

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

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Språk

Publicerad

2009-12-17
PDF · 603 SEK
ISO 18113-1:2009
Standard · ISO standard ISO 18113-1:2009

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

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Språk

Publicerad

2009-12-17
PDF · 1.312 SEK
ISO 18113-2:2009
Standard · ISO standard ISO 18113-2:2009

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use

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Språk

Publicerad

2009-12-17
PDF · 603 SEK
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