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Norm

ÖNORM EN ISO 10993-10

Issue date: 2003 03 01

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002)

Dieser Teil der Norm beschreibt Verfahren für die Beurteilung von Medizinprodukten und ihrer Bestandteile hinsichtlich des Hervorrufens einer Irritation und einer Allergi...

Withdrawn: 2006 12 01

§ Legal References

Publisher:

Austrian Standards International

Format:

Digital | 61 Pages

Language:

German | English

Currently valid:

ÖNORM EN ISO 10993-10:2023 07 15

Optionally co-design standards:

Committee 179: Medical technology

ICS

11.100.20

Topics

Healthcare, Laboratory medicine, Biological evaluation of medical devices

Summary

Norm timeline

Normative References

Dieser Teil der Norm beschreibt Verfahren für die Beurteilung von Medizinprodukten und ihrer Bestandteile hinsichtlich des Hervorrufens einer Irritation und einer Allergie vom verzögerten Typ. Es sind enthalten: a) vor der Prüfung durchzuführende Überlegungen; b) die Durchführung der Prüfung; c) Schlüsselfaktoren bei der Auslegung der Ergebnisse.

ÖNORM EN ISO 10993-10

2023 07 15

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)...

Norm

ÖNORM EN ISO 10993-10

2014 10 15

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

Norm

ÖNORM EN ISO 10993-10

2010 10 15

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

Norm

ÖNORM EN ISO 10993-10

2010 01 01

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensi...

Norm

ÖNORM EN ISO 10993-10

2006 12 01

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensi...

Norm

ÖNORM EN ISO 10993-10

2003 03 01

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensi...

Norm

↖

ÖNORM EN ISO 10993-10

1996 07 01

Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization (ISO 1099...

Norm

Expand

Norm

ISO 10993-18:2005

Issue date : 2005 06 30

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

Norm

ÖNORM EN ISO 10993-1

Issue date : 2003 12 01

Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)

Norm

ÖNORM EN ISO 10993-1

Issue date : 2009 03 01

Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003, not included)

Norm

ÖNORM EN ISO 10993-12

Issue date : 2008 03 01

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)

Norm

ÖNORM EN ISO 10993-12

Issue date : 2009 02 01

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)

Norm

ÖNORM EN ISO 10993-13

Issue date : 1999 05 01

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)

Norm

ÖNORM EN ISO 10993-13

Issue date : 2009 02 01

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)

Norm

ÖNORM EN ISO 10993-14

Issue date : 2002 05 01

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

Norm

ÖNORM EN ISO 10993-14

Issue date : 2009 02 01

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

Norm

ÖNORM EN ISO 10993-15

Issue date : 2001 05 01

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

Norm

ÖNORM EN ISO 10993-15

Issue date : 2009 03 01

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000, not included)

Norm

ÖNORM EN ISO 10993-2

Issue date : 2006 11 01

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)

Norm

ÖNORM EN ISO 10993-9

Issue date : 1999 09 01

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)

Norm

ÖNORM EN ISO 10993-9

Issue date : 2009 01 15

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)

Norm

ÖNORM EN ISO 14155-1

Issue date : 2003 07 01

Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)

Norm

ÖNORM EN ISO 14155-1

Issue date : 2009 04 01

Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003, not included)

Norm

ÖNORM EN ISO 14155-2

Issue date : 2003 07 01

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

Norm

ÖNORM EN ISO 14155-2

Issue date : 2009 04 01

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003, not included)

Norm

ISO 10993-1:1997

Issue date : 1997 12 11

Biological evaluation of medical devices — Part 1: Evaluation and testing

Norm

ISO 10993-2:1992

Issue date : 1992 12 30

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

Norm

ISO 10993-9:1999

Issue date : 1999 03 04

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

Norm

ISO 10993-12:1996

Issue date : 1996 09 05

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

Norm

ISO 10993-13:1998

Issue date : 1998 11 19

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

Norm

ISO 10993-14:2001

Issue date : 2001 11 22

Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics

Norm

ISO 10993-15:2000

Issue date : 2000 11 30

Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (Corrected version 2001-03)

Norm

ISO 10993-18:2020

Issue date : 2020 01 13

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process

Norm

ISO 14155-1:2003

Issue date : 2003 02 26

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

Norm

ISO 14155-2:2003

Issue date : 2003 05 16

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

Norm

ÖNORM EN ISO 10993-10

Issue date : 2006 12 01

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002) (consolidated version)

Norm

ISO 10993-10:2002

Issue date : 2002 09 26

Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity

ÖNORM EN ISO 10993-10

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