Complete List of the ISO 10993 Standards on Biological Evaluation of Medical Devices


ISO-10993-1

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

4TH EDITION. Issued: OCT. 15, 2009. 28 pages. CURRENT


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$138.00

ISO-10993-2

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

2ND EDITION. Issued: JULY 15, 2006. 20 pages. CURRENT


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$103.00

ISO-10993-3

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

3RD EDITION. Issued: OCT. 1, 2014. 41 pages. CURRENT


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$162.00

ISO-10993-4

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

3RD EDITION. Issued: APRIL 1, 2017. 76 pages. CURRENT


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$209.00

ISO-10993-4-1

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1


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ISO-10993-5

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

3RD EDITION. Issued: JUNE 1, 2009. 41 pages. CURRENT


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$162.00

ISO-10993-6

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

3RD EDITION. Issued: DEC. 1, 2016. 36 pages. CURRENT


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$162.00

ISO-10993-7

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

2ND EDITION. Issued: OCT. 15, 2008. 93 pages. CURRENT


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$232.00

ISO-10993-9

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

2ND EDITION. Issued: DEC. 15, 2009. 16 pages. CURRENT


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$68.00

ISO-10993-10

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

3RD EDITION. Issued: AUG. 1, 2010. 74 pages. CURRENT


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$209.00

ISO-10993-11

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

3RD EDITION. Issued: SEPT. 1, 2017. 36 pages. CURRENT


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$162.00

ISO-10993-12

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

4TH EDITION. Issued: JULY 1, 2012. 26 pages. CURRENT


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$138.00

ISO-10993-13

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

2ND EDITION. Issued: JUNE 15, 2010. 21 pages. CURRENT


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$103.00

ISO-10993-14

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

1ST EDITION. Issued: NOV. 15, 2001. 18 pages. CURRENT

$68.00

ISO-10993-15

Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys

1ST EDITION REPRINT. Issued: APRIL 1, 2001. 19 pages. CURRENT


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$68.00

ISO-10993-16

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

3RD EDITION. Issued: MAY 1, 2017. 20 pages. CURRENT


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$103.00

ISO-10993-17

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances

1ST EDITION. Issued: DEC. 1, 2002. 31 pages. CURRENT

$138.00

ISO-10993-18

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

1ST EDITION. Issued: JULY 1, 2005. 24 pages. CURRENT

$103.00

ISO-10993-19

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

1ST EDITION. Issued: JUNE 1, 2006. 22 pages. CURRENT

$103.00

ISO-10993-20

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

1ST EDITION. Issued: AUG. 1, 2006. 24 pages. CURRENT

$103.00