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 592:2002

UNE-EN 592:2002

Superseded Historical

Instructions for use for in vitro diagnostic instruments for self-testing.

€54.00

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UNE-EN 13640:2002

UNE-EN 13640:2002

Superseded Historical

Stability testing of in vitro diagnostic reagents.

€53.00

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UNE-EN ISO 14155-1:2003

UNE-EN ISO 14155-1:2003

Superseded Historical

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

€75.00

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UNE-EN ISO 14155-1:2003 ERRATUM:2005

UNE-EN ISO 14155-1:2003 ERRATUM:2005

Superseded Historical

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

€0.00

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UNE-EN ISO 10993-12:2005

UNE-EN ISO 10993-12:2005

Superseded Historical

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2002)

€73.00

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UNE-EN ISO 10993-18:2006

UNE-EN ISO 10993-18:2006

Superseded Historical

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

€73.00

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UNE-EN ISO 10993-4:2003/A1:2007

UNE-EN ISO 10993-4:2003/A1:2007

Superseded Historical

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2002/Amd 1:2006)

€50.00

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UNE-EN ISO 10993-10:2003/A1:2007

UNE-EN ISO 10993-10:2003/A1:2007

Superseded Historical

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity - Amendment 1 (ISO 10993-10:2002/Amd 1:2006)

€40.00

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UNE-EN 540:1994

UNE-EN 540:1994

Superseded Historical

CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS.

€61.00

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UNE-EN 1658:1997

UNE-EN 1658:1997

Withdrawn Most Recent

REQUIREMENTS FOR MARKING OF IN VITRO DIAGNOSTIC INSTRUMENTS.

€47.00

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UNE-EN 12286:1999

UNE-EN 12286:1999

Superseded Historical

IN VITRO DIAGNOSTIC MEDICAL DEVICES. MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN. PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES.

€73.00

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UNE-EN 12376:1999

UNE-EN 12376:1999

Superseded Historical

IN VITRO DIAGNOSTIC MEDICAL DEVICES. INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY.

€69.00

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UNE-EN 30993-3:1994

UNE-EN 30993-3:1994

Superseded Historical

BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY. (ISO 10993-3:1992)

€59.00

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UNE-EN 30993-4:1994

UNE-EN 30993-4:1994

Superseded Historical

BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:92)

€75.00

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UNE-EN 30993-5:1995

UNE-EN 30993-5:1995

Superseded Historical

BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 5: TEST FOR CYTOTOXICITY: IN VITRO METHODS. (ISO 10993-5:1992).

€61.00

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