Top Selling Medical Device Standards

IEC-80002-1

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

EDITION 1.0. Issued: SEPT. 1, 2009. 68 pages. CURRENT

$352.00

IEC-62354

General testing procedures for medical electrical equipment

EDITION 3.0. Issued: SEPT. 25, 2014. 218 pages. CURRENT


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$410.00

ISO-13485

Medical devices - Quality management systems - Requirements for regulatory purposes

3RD EDITION. Issued: MARCH 1, 2016. 46 pages. CURRENT


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$185.00

ISO-14969

Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003


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ISO-14971

Medical devices - Application of risk management to medical devices

2ND EDITION REPRINT. Issued: OCT. 1, 2007. 88 pages. CURRENT


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$232.00

ISO-11137-1

Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

1ST EDITION. Issued: APRIL 15, 2006. 44 pages. CURRENT

$185.00

ISO-11137-2

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

3RD EDITION. Issued: JUNE 1, 2013. 76 pages. CURRENT


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$209.00

ISO-11137-3

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control

2ND EDITION. Issued: JUNE 15, 2017. 48 pages. CURRENT


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$185.00

ISO-11607-1

Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems

1ST EDITION. Issued: APRIL 15, 2006. 30 pages. CURRENT

$138.00

ISO-11607-2

Packaging for Terminally Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes

1ST EDITION. Issued: APRIL 15, 2006. 17 pages. CURRENT

$68.00

ISO-11737-1

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products

2ND EDITION. Issued: APRIL 1, 2006. 42 pages. CURRENT


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$185.00

ISO-11737-2

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

2ND EDITION. Issued: NOV. 15, 2009. 22 pages. CURRENT


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$103.00

BS-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

BS-EN-980

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


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BS-EN-55011

Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement


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ANSI/AAMI-ST79

Comprehensive guide to steam sterilization and sterility assurance in health care facilities (ANSI/AAMI ST79:2017)

2017 EDITION. Issued: AUG. 1, 2017. CURRENT


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$495.00

AAMI-TIR12

Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

2010 EDITION. Issued: DEC. 7, 2010. 53 pages. CURRENT


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$277.50

AAMI-HE75

Human factors engineering - Design of medical devices

2009 EDITION. Issued: NOV. 1, 2009. 445 pages. CURRENT

$460.00

UL-60601-1

Medical Electrical Equipment, Part 1: General Requirements for Safety

1ST EDITION. Issued: APRIL 17, 2003. 348 pages. CURRENT

$641.00

NFPA-99

Health Care Facilities Code

2015 EDITION. Issued: JAN. 1, 2015. 207 pages. CURRENT


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$89.40