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Handbook of Medical Devices Standards by AptSkill

Handbook of Medical Devices Standards by AptSkill

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176 views4 pages

Handbook of Medical Devices Standards by AptSkill

Handbook of Medical Devices Standards by AptSkill

Uploaded by

AptSkill
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Handbook of Medical Devices Standards by AptSkill

Curated by Aakash Jindal

List of Standards Applicable to Medical Devices


Note: The list covers majority of the applicable regulations/guidelines however, the list is
non-exhaustive.

1. ISO 13485
- Title: Medical devices – Quality management systems – Requirements for regulatory
purposes
- Description: Specifies the requirements for a quality management system in the
design and production of medical devices.
- Application: Ensures compliance with regulatory standards in the manufacturing and
distribution of medical devices.

2. ISO 14971
- Title: Medical devices – Application of risk management to medical devices
- Description: Provides a framework for identifying, evaluating, and managing risks
associated with medical devices throughout their lifecycle.
- Application: Ensures systematic risk assessment and management in the
development and post-market phases.

3. ISO 15223-1
- Title: Medical devices – Symbols to be used with medical device labels, labeling, and
information to be supplied
- Description: Specifies symbols and labels to convey essential information on medical
device labels.
- Application: Ensures clear and standardized communication of information on
medical devices.

4. ISO 10993-1
- Title: Biological evaluation of medical devices – Part 1: Evaluation and testing within
a risk management process
- Description: Guides the biological evaluation of medical devices to assess potential
risks to human health.
- Application: Ensures the safety of medical devices by assessing their biological
impact on patients.

5. ISO 14644
- Title: Cleanrooms and associated controlled environments
- Description: Establishes cleanliness and contamination control standards for
cleanrooms in various industries, including medical device manufacturing.
- Application: Ensures controlled environments to prevent contamination during the
production of medical devices.

6. ISO 11737
- Title: Sterilization of medical devices – Microbiological methods
- Description: Outlines methods for assessing the microbial contamination of medical
devices.
- Application: Ensures effective sterilization processes to maintain device sterility.

7. ISO 11607
- Title: Packaging for terminally sterilized medical devices
- Description: Sets requirements for the packaging of sterile medical devices.
- Application: Ensures the integrity and sterility of medical devices throughout the
distribution chain.

8. ISO 20417
- Title: Medical devices – Information to be supplied by the manufacturer
- Description: Specifies requirements for information provided by the manufacturer for
medical devices.
- Application: Ensures comprehensive and accurate information is available for users
and regulators.

9. IEC 60601 (For active devices)


- Title: Medical electrical equipment – General requirements for basic safety and
essential performance
- Description: Defines safety and performance requirements for medical electrical
equipment.
- Application: Ensures the safety and performance of active medical devices.

10. ASTM F1980


- Title: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical
Devices
- Description: Provides guidelines for accelerated aging studies to predict the life of
sterile barrier systems.
- Application: Assesses the aging and durability of packaging materials for medical
devices.

11. ASTM D4169


- Title: Standard Practice for Performance Testing of Shipping Containers and
Systems
- Description: Specifies procedures for testing the performance of shipping containers
and systems.
- Application: Ensures the integrity of packaging during transportation, safeguarding
medical devices.

12. EN 556-1
- Title: Sterilization of medical devices – Requirements for medical devices to be
designated "STERILE" – Part 1: Requirements for terminally sterilized medical devices
- Description: Specifies requirements for labeling medical devices as "STERILE" after
terminal sterilization.
- Application: Ensures proper labeling of terminally sterilized medical devices.

13. ISO 14155


- Title: Clinical investigation of medical devices for human subjects – Good clinical
practice
- Description: Provides guidelines for conducting ethical and scientifically valid clinical
investigations.
- Application: Ensures the quality and integrity of clinical data supporting the safety
and performance of medical devices.

14. ISO 11135


- Title: Sterilization of health care products – Ethylene oxide – Requirements for the
development, validation, and routine control of a sterilization process for medical
devices
- Description: Specifies requirements for the sterilization process using ethylene oxide.
- Application: Ensures effective and safe sterilization of medical devices with ethylene
oxide.

15. IEC 62304, IEC 82304 (SAMD)


- Title: Medical device software – Software life cycle processes
- Description: Provides a framework for the software development life cycle for
medical devices.
- Application: Ensures the reliability and safety of software used in medical devices.

16. ISO 25424


- Title: Sterilization of health care products – Low temperature steam and
formaldehyde – Requirements for development, validation, and routine control of a
sterilization process for medical devices
- Description: Specifies requirements for the sterilization process using low-
temperature steam and formaldehyde.
- Application: Ensures effective and safe sterilization of medical devices with this
method.
17. ISO 17665-1
- Title: Sterilization of health care products – Moist heat – Part 1: Requirements for the
development, validation, and routine control of a sterilization process for medical
devices
- Description: Specifies requirements for the sterilization process using moist heat.
- Application: Ensures effective and safe sterilization of medical devices with moist
heat.

18. ISO 11137


- Title: Sterilization of health care products – Radiation – Part 1: Requirements for
development, validation, and routine control of a sterilization process for medical
devices
- Description: Specifies requirements for the sterilization process using radiation.
- Application: Ensures effective and safe sterilization of medical devices using
radiation.

19. IEC 62366-1


- Title: Medical devices – Application of usability engineering to medical devices
- Description: Provides guidance on incorporating human factors engineering into the
design of medical devices.
- Application: Ensures the usability and safety of medical devices by considering
human factors in design.

These standards collectively contribute to the development, manufacturing,


sterilization, packaging, and clinical use of medical devices, ensuring their safety,
efficacy, and regulatory compliance.

Reach out to us at Aptskill6@gmail.com to enroll for high quality, interactive courses


on various medical devices related topics.

Contact: +91 8262083746

Medical Devices Trainings:


- Medical Devices Regulatory Affairs for EU
- Medical Devices Regulatory Affairs for US
- Medical Devices India Regulatory
- Quality Engineering Trainings
- Process Engineering Trainings
- RAC (Devices) Trainings

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