Standards updates for last 6 months
Medical device standards are a set of guidelines and requirements that ensure the safety, effectiveness, and quality of medical devices. These standards are established by various international and regional organizations, such as the International Organization for Standardization (ISO), International Electrotechnical Commission (IEC), and Association for the Advancement of Medical Instrumentation (AAMI) which is and ANSI (American National Standards Institute)-accredited standards development organization. They cover a wide range of aspects related to medical devices, including their design, manufacturing, testing, labeling, and post-market surveillance. The Medical device standards that are updated in last 6 months are listed out in the below table.
| Standard Code | Standard Name | Status | Stage | Last Updated |
|---|---|---|---|---|
| ISO Standards | ||||
| ISO 14708-1:2014 | Implants for surgery Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer | Published | International Standard to be revised [90.92] | July 2024 |
| ISO 14708-1 | Implants for surgery Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer | Under Development | CD consultation initiated [30.20] | July 2024 |
| ISO 11138-7:2019 | Sterilization of health care products Biological indicators Part 7: Guidance for the selection, use and interpretation of results | Published | International Standard confirmed [90.93] | July 2024 |
| ISO 11137-2:2013 | Sterilization of health care products Radiation Part 2: Establishing the sterilization dose | Published | International Standard to be revised [90.92] | July 2024 |
| ISO 11607-1:2019 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems | Published | International Standard confirmed [90.93] | July 2024 |
| ISO 11607-2:2019 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes | Published | International Standard confirmed [90.93] | July 2024 |
| ISO 10993-3:2014 | Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | Published | International Standard to be revised [90.92] | July 2024 |
| ISO 10993-3 | Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | Under Development | CD consultation initiated [30.20] | July 2024 |
| ISO 13482 | Robotics Safety requirements for service robots | Under Development | DIS ballot initiated: 12 weeks [40.20] | August 2024 |
| ISO 27186 | Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices Dimensional and test requirements | Under Development | DIS ballot initiated: 12 weeks [40.20] | August 2024 |
| ISO 15883-2 | Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices | Under Development | Proof sent to secretariat or FDIS ballot initiated: 8 weeks [50.20] | August 2024 |
| ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices Requirements and test methods | Published | International Standard to be revised [90.92] | September 2024 |
| ISO 9626 | Stainless steel needle tubing for the manufacture of medical devices Requirements and test methods | Under development | CD consultation initiated [30.20] | September 2024 |
| ISO 15883-1:2006 | Washer-disinfectors Part 1: General requirements, terms and definitions and tests | Withdrawn | Withdrawal of International Standard [95.99] | October 2024 |
| ISO 15883-1:2024 | Washer-disinfectors Part 1: General requirements, terms and definitions and tests | Published | International Standard published [60.60] | October 2024 |
| ISO 23640:2011 | In vitro diagnostic medical devices Evaluation of stability of in vitro diagnostic reagents | Published | International Standard to be revised [90.92] | October 2024 |
| ISO 23640 | In vitro diagnostic medical devices Evaluation of stability of in vitro diagnostic reagents | Under Development | CD consultation initiated [30.20] | October 2024 |
| ISO 11040-8 | Prefilled syringes Part 8: Requirements and test methods for finished prefilled syringes | Under Development | CD consultation initiated [30.20] | October 2024 |
| ISO 10993-2 | Biological evaluation of medical devices Part 2: Animal welfare requirements | Under Development | DIS ballot initiated: 12 weeks [40.20] | November 2024 |
| ISO 15883-2:2006 | Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. | Withdrawn | Withdrawal of International Standard [95.99] | November 2024 |
| ISO 15883-2:2024 | Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices | Published | International Standard published [60.60] | November 2024 |
| ISO 20417 | Medical devices Information to be supplied by the manufacturer | Under development | DIS ballot initiated: 12 weeks [40.20] | November 2024 |
| ISO 10993-4:2017 | Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood | Published | International Standard to be revised [90.92] | November 2024 |
| ISO 10993-4 | Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood | Under development | New project approved [10.99] | November 2024 |
| ISO 80369-20:2024 | Small-bore connectors for liquids and gases in healthcare applications | Published | International Standard published [60.60] | November 2024 |
| ISO 11137-1 | Sterilization of health care products Radiation Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | Under development | Proof sent to secretariat or FDIS ballot initiated: 8 weeks [50.20] | December 2024 |
| ANSI Standards | ||||
| ANSI AAMI ST58:2013/(R)2018 | Chemical sterilization and high-level disinfection in health care facilities | Historical | N/A | September 2024 |
| ANSI AAMI ST58: 2024 | Chemical sterilization and high-level disinfection in health care facilities | Current | N/A | September 2024 |
| ASTM Standards | ||||
| ASTM F2503-23 | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment | Historical | N/A | October 2024 |
| ASTM F2503-23e1 | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment | Active | N/A | October 2024 |
| ASTM F3127-16 | Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices | Historical | N/A | October 2024 |
| ASTM F3127-22 | Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices | Active | N/A | October 2024 |
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