11.100 : Laboratory medicine

11.100.01

Laboratory medicine in general

11.100.10

In vitro diagnostic test systems

11.100.20

Biological evaluation of medical devices

11.100.30

Analysis of blood and urine

11.100.99

Other standards related to laboratory medicine
UNE-EN ISO 10993-5:2000

UNE-EN ISO 10993-5:2000

Superseded Historical

BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 5: TESTS FOR IN VITRO CYTOTOXICITY (ISO 10993-5:1999)

€62.00

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UNE-EN ISO 10993-15:2001

UNE-EN ISO 10993-15:2001

Superseded Historical

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

€69.00

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UNE-EN 375:2001

UNE-EN 375:2001

Superseded Historical

INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE.

€62.00

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UNE-EN 13503-5:2001

UNE-EN 13503-5:2001

Superseded Historical

Ophthalmic implants. Intraocular lenses. Part 5: Biocompatibility. (ISO 11979-5:1999, modified)

€69.00

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UNE-EN ISO 10993-5:2002 ERRATUM

UNE-EN ISO 10993-5:2002 ERRATUM

Superseded Historical

Biological evaluation of medical devices. Part 5: Tests for in vitro cytotoxicity. (ISO 10993-5:1999)

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UNE-EN ISO 10993-4:2003

UNE-EN ISO 10993-4:2003

Superseded Historical

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002)

€92.00

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UNE-EN ISO 10993-17:2003

UNE-EN ISO 10993-17:2003

Superseded Historical

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

€78.00

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UNE-EN ISO 15189:2003

UNE-EN ISO 15189:2003

Superseded Historical

Medical laboratories - Particular requirements for quality and competence (ISO 15189:2003)

€96.00

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UNE-EN ISO 14155-2:2004

UNE-EN ISO 14155-2:2004

Superseded Historical

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

€60.00

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UNE-EN ISO 10993-1:2004

UNE-EN ISO 10993-1:2004

Superseded Historical

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

€69.00

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UNE-EN ISO 10993-3:2004

UNE-EN ISO 10993-3:2004

Superseded Historical

Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicty and reproductive toxicity (ISO10993-3:2003)

€71.00

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NBN EN ISO 22870:2006

NBN EN ISO 22870:2006

Superseded Historical

Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2006)

€50.00

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NBN EN ISO 10993-6:2007

NBN EN ISO 10993-6:2007

Superseded Historical

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

€50.00

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NBN EN ISO 10993-11:2006

NBN EN ISO 10993-11:2006

Superseded Historical

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

€50.00

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NBN EN ISO 22442-2:2008

NBN EN ISO 22442-2:2008

Superseded Historical

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)

€50.00

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