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

$430.68

IEC-62354

General testing procedures for medical electrical equipment

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


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$530.59

ISO-13485

Medical devices - Quality management systems - Requirements for regulatory purposes

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


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$216.31

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

3RD EDITION. Issued: DEC. 1, 2019. 36 pages. CURRENT


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$216.31

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

$216.31

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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$242.50

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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$216.31

ISO-11607-1

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

2ND EDITION. Issued: FEB. 1, 2019. 30 pages. CURRENT


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$216.31

ISO-11607-2

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

2ND EDITION. Issued: FEB. 1, 2019. 17 pages. CURRENT


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$120.28

ISO-11737-1

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products

3RD EDITION. Issued: JAN. 1, 2018. CURRENT


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$216.31

ISO-11737-2

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

3RD EDITION. Issued: DEC. 1, 2019. 16 pages. CURRENT


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$120.28

BS-EN-556-1

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

2024 EDITION. Issued: JULY 3, 2024. 20 pages. CURRENT


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$195.00

BS-EN-980

Symbols for use in the labelling of medical devices


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BS-EN-55011

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

2016/A2 EDITION. Issued: APRIL 14, 2021. 110 pages. CURRENT


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$372.50

ANSI/AAMI-ST79

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

2017 CONSOLIDATED EDITION. Issued: JAN. 15, 2021. 248 pages. CURRENT


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$448.14

AAMI-TIR12

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

2020 R23 EDITION. Issued: JAN. 1, 2023. CURRENT


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$266.75

AAMI-HE75

Human factors engineering - Design of medical devices

2009 R18 EDITION. Issued: AUG. 10, 2018. 445 pages. CURRENT


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$468.51

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

2024 EDITION. Issued: AUG. 25, 2023. 272 pages. CURRENT


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$171.35