11.040.01: Medical equipment in general
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MOST RECENT
ISO 15378:2017/Amd1:2024
- Amendment 1: Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes
Amendment by International Organization for Standardization, 02/01/2024.
Languages: English
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MOST RECENT
ISO/TR 80001-2-7:2015
Application of risk management for IT-networks incorporating medical devices - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
standard by International Organization for Standardization (Technical Report), 04/01/2015.
Languages: English
- MULTI-USER
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MOST RECENT
ISO/TR 80001-2-6:2014
Application of risk management for IT-networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements
standard by International Organization for Standardization (Technical Report), 12/01/2014.
Languages: English
- MULTI-USER
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MOST RECENT
ISO 32000-1:2008
Document management -- Portable document format -- Part 1: PDF 1.7
standard by International Organization for Standardization, 07/01/2008.
Languages: English
- MULTI-USER
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MOST RECENT
ISO/TS 20225:2001 [ Withdrawn ]
Global medical device nomenclature for the purpose of regulatory data exchange
standard by International Organization for Standardization (Technical Standard), 11/01/2001.
Languages: English
- MULTI-USER
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MOST RECENT
ISO 20069:2019
Guidance for assessment and evaluation of changes to drug delivery systems
standard by International Organization for Standardization, 08/01/2019.
Languages: English
- MULTI-USER
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MOST RECENT
ISO/TR 19244:2014
Guidance on transition periods for standards developed by ISO/TC 84 - Devices for administration of medicinal products and catheters
standard by International Organization for Standardization (Technical Report), 08/15/2014.
Languages: English
- MULTI-USER
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MOST RECENT
ISO/IEC Guide 63:2019
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
standard by International Organization for Standardization/International Electrotechnical Commission, 08/01/2019.
Languages: English
Historical Editions: ISO/IEC Guide 63:2012, ISO/IEC Guide 63:1999
- MULTI-USER
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HISTORICAL
ISO 13485 AND 14969 PACKAGE
This document has been replaced. View the most recent version.
ISO 13485:2003 and ISO/TR 14969:2004 Quality Managment Systems Medical Devices Package
standard by International Organization for Standardization, 10/15/2004.
Languages:
Historical Editions: ISO 13485:2016 Plus Redline, ISO 13485:2016, ISO/TR 14969:2004, ISO 13485:2003, ISO 13485:1996
- MULTI-USER
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HISTORICAL
ISO 14971:2019 Plus Redline
This document has been replaced. View the most recent version.
Medical devices - Application of risk management to medical devices
standard by International Organization for Standardization, 12/01/2019.
Languages: English
Historical Editions: ISO 14971:2019, ISO 14971:2007, ISO 14971/Amd1:2003, ISO 14971:2000
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