Complete list of the Harmonized Standards for 90/385/eec

List of European Harmonized Standards For Directive 90/385/EEC, Active Implantable Medical Devices (with links to the Official English Language Edition of each)




EN-556-1

Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices

2001 EDITION. Issued: DEC. 11, 2001. 12 pages. CURRENT

$129.36

EN-556-2

Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices

2015 EDITION. Issued: SEPT. 30, 2015. 20 pages. CURRENT


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$140.40

EN-980

Symbols for use in the labelling of medical devices - Replaced by BS-EN-ISO-15223-1


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EN-1041

Information supplied by the manufacturer of medical devices

2008/A1 EDITION. Issued: OCT. 15, 2013. 28 pages. CURRENT


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$213.20

EN-ISO-10993-1

Biological evaluation of medical devices. Evaluation and testing within a risk management process

10/2009 EDITION. Issued: JUNE 30, 2010. 34 pages. CURRENT


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$247.00

EN-ISO-10993-5

Biological evaluation of medical devices. Tests for in vitro cytotoxicity

2009 EDITION. Issued: JULY 31, 2009. 46 pages. CURRENT


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$270.00

EN-ISO-10993-6

Biological evaluation of medical devices. Tests for local effects after implantation

2016 EDITION. Issued: DEC. 31, 2016. 46 pages. CURRENT


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$270.00

EN-ISO-10993-7

Biological evaluation of medical devices. Ethylene oxide sterilization residuals

2008 EDITION. Issued: DEC. 31, 2008. 98 pages. CURRENT


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$305.00

EN-ISO-10993-9

Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products

2009 EDITION. Issued: JUNE 30, 2009. 18 pages. CURRENT


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$150.80

EN-ISO-10993-11

Biological evaluation of medical devices. Tests for systemic toxicity

2009 EDITION. Issued: JUNE 30, 2009. 38 pages. CURRENT


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$247.00

EN-ISO-10993-12

Biological evaluation of medical devices. Sample preparation and reference materials

2012 EDITION. Issued: OCT. 31, 2012. 34 pages. CURRENT


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$247.00

EN-ISO-10993-13

Biological evaluation of medical devices. Identification and quantification of degradation products from polymeric medical devices

2010 EDITION. Issued: OCT. 31, 2010. 28 pages. CURRENT


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$213.20

EN-ISO-10993-16

Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables

2010 EDITION. Issued: MARCH 31, 2010. 22 pages. CURRENT


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$150.80

EN-ISO-10993-17

Biological evaluation of medical devices. Establishment of allowable limits for leachable substances

2009 EDITION. Issued: JUNE 30, 2009. 36 pages. CURRENT


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$247.00

EN-ISO-10993-18

Biological evaluation of medical devices. Chemical characterization of materials

2009 EDITION. Issued: JUNE 30, 2009. 28 pages. CURRENT


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$213.20

EN-ISO-11135-1

Sterilization of health care products. Ethylene oxide. Requirements for development, validation and routine control of a sterilization process for medical devices


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EN-ISO-11137-1

Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices

2015 EDITION. Issued: JULY 31, 2015. 54 pages. CURRENT


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$265.00

EN-ISO-11137-2

Sterilization of health care products. Radiation. Establishing the sterilization dose

2015 EDITION. Issued: JUNE 30, 2015. 84 pages. CURRENT


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$282.50

EN-ISO-11137-3

Sterilization of health care products. Radiation. Guidance on dosimetric aspects

2006 EDITION. Issued: MARCH 30, 2007. 28 pages. CURRENT

$213.20

EN-ISO-11140-1

Sterilization of health care products. Chemical indicators. General requirements

2014 EDITION. Issued: NOV. 30, 2014. 44 pages. CURRENT


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$247.00