IEC-80002-1Medical 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 |
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IEC-62354General testing procedures for medical electrical equipment EDITION 3.0. Issued: SEPT. 25, 2014. 218 pages. CURRENT Show IEC-62354 revision history |
$530.59 |
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ISO-13485Medical devices - Quality management systems - Requirements for regulatory purposes 3RD EDITION. Issued: MARCH 1, 2016. 46 pages. CURRENT Show ISO-13485 revision history |
$216.31 |
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ISO-14969Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003 Show ISO-14969 revision history |
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ISO-14971Medical devices - Application of risk management to medical devices 3RD EDITION. Issued: DEC. 1, 2019. 36 pages. CURRENT Show ISO-14971 revision history |
$216.31 |
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ISO-11137-1Sterilization 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 |
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ISO-11137-2Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose 3RD EDITION. Issued: JUNE 1, 2013. 76 pages. CURRENT Show ISO-11137-2 revision history |
$242.50 |
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ISO-11137-3Sterilization 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 Show ISO-11137-3 revision history |
$216.31 |
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ISO-11607-1Packaging 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 Show ISO-11607-1 revision history |
$216.31 |
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ISO-11607-2Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes 2ND EDITION. Issued: FEB. 1, 2019. 17 pages. CURRENT Show ISO-11607-2 revision history |
$120.28 |
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ISO-11737-1Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products 3RD EDITION. Issued: JAN. 1, 2018. CURRENT Show ISO-11737-1 revision history |
$216.31 |
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ISO-11737-2Sterilization 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 Show ISO-11737-2 revision history |
$120.28 |
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BS-EN-556-1Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE' 2001 EDITION. Issued: DEC. 11, 2001. 12 pages. CURRENT |
$143.00 |
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BS-EN-980Symbols for use in the labelling of medical devices Show BS-EN-980 revision history |
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BS-EN-55011Industrial, scientific and medical equipment. Radio-frequency disturbance characteristics. Limits and methods of measurement 2016/A2 EDITION. Issued: APRIL 14, 2021. 110 pages. CURRENT Show BS-EN-55011 revision history |
$372.50 |
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ANSI/AAMI-ST79Comprehensive 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 Show ANSI/AAMI-ST79 revision history |
$448.14 |
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AAMI-TIR12Designing, 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 Show AAMI-TIR12 revision history |
$266.75 |
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AAMI-HE75Human factors engineering - Design of medical devices 2009 R18 EDITION. Issued: AUG. 10, 2018. 445 pages. CURRENT Show AAMI-HE75 revision history |
$468.51 |
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UL-60601-1Medical Electrical Equipment, Part 1: General Requirements for Safety 1ST EDITION. Issued: APRIL 17, 2003. 348 pages. CURRENT |
$641.00 |
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NFPA-99Health Care Facilities Code 2024 EDITION. Issued: AUG. 25, 2023. 272 pages. CURRENT Show NFPA-99 revision history |
$171.35 |