21 CFR Chapter I Subchapter H β Medical Devices β Part 880 General Hospital and Personal Use Devices From Food and Drug Administration (FDA) πΊπΈ 21 CFR Chapter I Subchapter H - Medical Devices - Part 880 General Hospital and Personal Use Devices. Regulation. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated on August 19, 2024 Other (Public Domain) 0 reuses 0 favorites
Commission Implementing Decision (EU) 2024/817 of 6Β March 2024 amending Implementing Decision (EU)Β 2021/1195 as regards harmonised standards for sterilisation of health care products and packaging for terminally sterilised medical devices From European Parliament πͺπΊ The document is an EU Implementing Decision from 2024 amending standards for sterilization of healthcare products and packaging for medical devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 6, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2024/815 of 6Β March 2024 amending Implementing Decision (EU)Β 2021/1182 as regards harmonised standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products From European Parliament πͺπΊ The document is a Commission Implementing Decision amending standards for medical gloves, biological evaluation of devices, sterilization, packaging, and processing of healthcare products. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 6, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2023/1410 of 4Β July 2023 amending Implementing Decision (EU)Β 2021/1182 as regards harmonised standards for sterilization of health care products and biological evaluation of medical devices From European Parliament πͺπΊ Commission Implementing Decision (EU) 2023/1410 amends harmonised standards for sterilization of healthcare products and biological evaluation of medical devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 4, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
CPG Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices From Food and Drug Administration (FDA) πΊπΈ This document is a Compliance Policy Guide (CPG) that discusses the status and responsibilities of contract sterilizers in drug and device sterilization. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 24, 2023 Other (Public Domain) 0 reuses 0 favorites
Commission Implementing Decision (EU) 2022/757 of 11Β May 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for quality management systems, sterilisation and application of risk management to medical devices From European Parliament πͺπΊ Commission Implementing Decision (EU) 2022/757 amends Implementing Decision (EU) 2021/1182 on harmonised standards for quality management systems and risk management in medical devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 11, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2022/6 of 4Β January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment From European Parliament πͺπΊ Commission Implementing Decision (EU) 2022/6 amends EU standards for medical devices, sterilization, quality management, and more. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 4, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2021/611 of 14Β April 2021 amending Implementing Decision (EU) 2020/438 as regards harmonised standards on biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products and clinical investigation of medical devices for human subjects From European Parliament πͺπΊ Commission Implementing Decision (EU) 2021/611 amends Implementing Decision (EU) 2020/438 on harmonised standards for medical devices and clinical investigations. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 14, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2021/610 of 14Β April 2021 amending Implementing Decision (EU) 2020/437 as regards harmonised standards on medical vehicles and their equipment, anaesthetic and respiratory equipment, biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products, clinical investigation of medical devices for human subjects, non-active surgical implants, medical devices utilising animal tissues and their derivatives, electroacoustics and medical electrical equipment From European Parliament πͺπΊ Amendment to Implementing Decision (EU) 2020/437 on harmonised standards for medical vehicles, equipment, and devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 14, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2021/609 of 14Β April 2021 amending Implementing Decision (EU) 2020/439 as regards harmonised standards on packaging for terminally sterilised medical devices and sterilisation of health care products From European Parliament πͺπΊ Commission Implementing Decision (EU) 2021/609 amends standards on packaging for sterilised medical devices and sterilisation of healthcare products. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 14, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guidance ('Guidelines') for Evaluation of Hysteroscopic Sterilization Devices From Food and Drug Administration (FDA) πΊπΈ A guidance document titled "Guidelines for Evaluation of Hysteroscopic Sterilization Devices" for premarket evaluation. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 17, 2020 Other (Public Domain) 0 reuses 0 favorites
Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for labeling and adverse event reporting of hysteroscopically-placed tubal implants for sterilization. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 9, 2019 Other (Public Domain) 0 reuses 0 favorites
Statement regarding Use of ISO 11137-1:2006 "Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices" From International Medical Device Regulators Forum (IMDRF) π Information document IMDRF/MC/N38 FINAL:2015. Metadata quality: Metadata quality: Data description empty Files documented License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on October 2, 2015 Other (Public Domain) 0 reuses 0 favorites
Guidance Document: Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices From Health Canada π¨π¦ 2011 Health Canada guidance document Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 24, 2011 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Recall of a batch of Tyvek sterilization pouch From National Organization for Medicines (EOF) π¬π· The manufacturer Advanced Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on April 5, 2011 Other (Public Domain) 0 reuses 0 favorites
Notice of adjustments to the management of medical indoor air sterilization equipment From National Medical Products Administration (NMPA) π¨π³ FGWJ-2009-10347 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 10, 2009 Other (Public Domain) 0 reuses 0 favorites
Circular on radiation sterilization of medical utensils (disposable equipment) consisting mainly of plastic (for manufacturers and consumers of medical utensils) From Danish Medicines Agency (DKMA) π©π° A circular providing guidelines on radiation sterilization of plastic medical utensils for manufacturers and consumers. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 19, 1968 Other (Public Domain) 0 reuses 0 favorites