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Standard · ISO standard ISO 10993-9

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

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Språk

Publicerad

1999-01-26

Upphävd

2009-11-30

PDF · 529 SEK
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
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
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
Standard · ISO standard ISO 18113-3:2009

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for profession...

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Språk

Publicerad

2009-12-17

PDF · 603 SEK
Standard · ISO standard ISO 18113-5:2009

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing

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Språk

Publicerad

2009-12-17

PDF · 529 SEK
Standard · ISO standard ISO 10993-4:2002/Amd 1:2006

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

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Språk

Publicerad

2006-09-06

PDF · 315 SEK
Standard · ISO standard ISO 10993-16

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

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Språk

Publicerad

1997-08-28

Upphävd

2010-02-09

PDF · 603 SEK
Standard · ISO standard ISO 18113-4:2009

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing

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Språk

Publicerad

2010-01-26

PDF · 603 SEK
Standard · ISO standard ISO 10993-13

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

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Språk

Publicerad

1998-10-19

Upphävd

2010-06-04

PDF · 603 SEK
Standard · ISO standard ISO 14155-2

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans

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Språk

Publicerad

2003-04-16

Upphävd

2011-01-21

PDF · 603 SEK
Standard · ISO standard ISO 14155-1

Clinical investigation of medical devices for human subjects - Part 1: General requirements

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Språk

Publicerad

2003-02-26

Upphävd

2011-01-21

PDF · 920 SEK
Standard · ISO standard ISO 10993-16:2010

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

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Språk

Publicerad

2010-02-25

PDF · 676 SEK
Standard · ISO standard ISO/TR 22442-4:2010

Medical devices utilizing animal tissues and their derivatives - Part 4: Principles for elimination and/or inactivation of transmissible spongiform...

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Språk

Publicerad

2010-11-30

PDF · 730 SEK
Standard · ISO standard ISO 14155:2011

Clinical investigation of medical devices for human subjects - Good clinical practice

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Språk

Publicerad

2011-01-26

PDF · 1.380 SEK
Standard · ISO standard ISO 10993-13:2010

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

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Språk

Publicerad

2010-06-18

PDF · 730 SEK
Standard · ISO standard ISO 29701:2010

Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test

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Språk

Publicerad

2010-09-08

PDF · 835 SEK
Standard · ISO standard ISO 10993-10:2010

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

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Språk

Publicerad

2010-08-25

PDF · 1.466 SEK
Standard · ISO standard ISO 13079:2011

Laboratory glass and plastics ware -- Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method

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Språk

Publicerad

2011-08-19

PDF · 733 SEK
Standard · ISO standard ISO 13130:2011

Laboratory glassware -- Desiccators

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Språk

Publicerad

2011-08-19

PDF · 529 SEK
Standard · ISO standard ISO 13132:2011

Laboratory glassware -- Petri dishes

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Språk

Publicerad

2011-08-19

PDF · 456 SEK
Standard · ISO standard ISO 14155:2011/Cor 1:2011

Clinical investigation of medical devices for human subjects - Good clinical practice

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Språk

Publicerad

2011-08-19

PDF · 0 SEK
Standard · ISO standard ISO 10993-1:2009/Cor 1:2010

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

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Språk

Publicerad

2010-06-18

PDF · 0 SEK
Standard · ISO standard ISO 23640:2011

In vitro diagnostic medical devices -- Evaluation of stability of in vitro diagnostic reagents

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Språk

Publicerad

2011-12-16

PDF · 529 SEK
Standard · ISO standard ISO 13022:2012

Medical products containing viable human cells -- Application of risk management and requirements for processing practices

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Språk

Publicerad

2012-04-10

PDF · 1.312 SEK
Standard · ISO standard ISO 10993-12:2007

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

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Språk

Publicerad

2007-11-15

Upphävd

2012-06-29

PDF · 784 SEK
Standard · ISO standard ISO 10993-12:2012

Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials

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Språk

Publicerad

2012-08-17

PDF · 835 SEK
Standard · ISO standard ISO 8600-7:2012

Endoscopes -- Medical endoscopes and endotherapy devices -- Part 7: Basic requirements for medical endoscopes of water-resistant type

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Språk

Publicerad

2012-08-17

PDF · 347 SEK
Standard · ISO standard ISO/TR 15499:2012

Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process

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Språk

Publicerad

2012-08-17

PDF · 730 SEK
Standard · ISO standard ISO/TR 7405

Biological evaluation of dental materials

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Språk

Publicerad

1984-01-01

Upphävd

1997-08-19

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