This presentation, ISO 10993-7 Biological Evaluation of Medical Devices - Ethylene Oxide Sterilization Residuals, discusses why it is necessary to test ethylene oxide (EO) and how to categorize your device.

1. ISO 10993-7:2008 Biological Evaluation of Medical
Devices Part 7: Ethylene Oxide Sterilization Residuals
Joe Brinkman
Medical Research Manager

2. 2
ISO 10993-7 specifies allowable limits and
compliance methods for residual ethylene
oxide (EO) and ethylene chlorohydrin (ECH)
in individual EO-sterilized medical devices.

3. 3
Why test Ethylene Oxide (EO)?

4. 4
Why test Ethylene Oxide (EO)?
EO is known to exhibit a number of biological effects.

5. 5
Why test Ethylene Oxide (EO)?
EO is known to exhibit a number of biological effects.
- Irritation
- Skin irritation, erythema, blisters and burns
- Eye irritation, cataracts after repeat exposure

6. 6
Why test Ethylene Oxide (EO)?
EO is known to exhibit a number of biological effects.
- Irritation
- Skin irritation, erythema, blisters and burns
- Eye irritation, cataracts after repeat exposure
- Organ damage
- Lungs – bronchitis, pulmonary edema and
emphysema
- Central nervous system – nausea, vomiting,
headaches

7. 7
Why test Ethylene Oxide (EO)?
EO is known to exhibit a number of biological effects.
- Irritation
- Skin irritation, erythema, blisters and burns
- Eye irritation, cataracts after repeat exposure
- Organ damage
- Lungs – bronchitis, pulmonary edema and
emphysema
- Central nervous system – nausea, vomiting,
headaches
- Mutagenicity
- Induces chromosomal aberrations

8. 8
Why test Ethylene Oxide (EO)?
- Cancer in animals and humans
- Lymphatic and other types of cancer

9. 9
Why test Ethylene Oxide (EO)?
- Cancer in animals and humans
- Lymphatic and other types of cancer
- Reproductive effects in animals

10. 10
Why test Ethylene Oxide (EO)?
- Cancer in animals and humans
- Lymphatic and other types of cancer
- Reproductive effects in animals
- Similar consideration was given to the harmful effects of
ECH and EG

11. 11
The Process

12. 12
The Process
Determine patient exposure

13. 13
The Process
Determine patient exposure
Select appropriate test method

14. 14
The Process
Determine patient exposure
Select appropriate test method
Prepare samples for testing

15. 15
The Process
Determine patient exposure
Select appropriate test method
Prepare samples for testing
Sterilize product

16. 16
The Process
Determine patient exposure
Select appropriate test method
Prepare samples for testing
Sterilize product
Perform test

17. 17
The Process
Determine patient exposure
Select appropriate test method
Prepare samples for testing
Sterilize product
Perform test
Interpret data

18. 18
Categorization of Devices

19. 19
Categorization of Devices
Non Patient Contacting – testing not required

20. 20
Categorization of Devices
Non Patient Contacting – testing not required
Limited Exposure – devices whose single or
cumulative repeated use or contact is up to 24 hours

21. 21
Categorization of Devices
Non Patient Contacting – testing not required
Limited Exposure – devices whose single or
cumulative repeated use or contact is up to 24 hours
Prolonged Exposure – devices whose single or
cumulative repeated use or contact is likely to exceed
24 hours but not 30 days

22. 22
Categorization of Devices
Non Patient Contacting – testing not required
Limited Exposure – devices whose single or
cumulative repeated use or contact is up to 24 hours
Prolonged Exposure – devices whose single or
cumulative repeated use or contact is likely to exceed
24 hours but not 30 days
Permanent Contact – devices whose single or
cumulative repeated use or contact exceeds 30 days

23. 23
Categorization of Devices
Direct Patient Contact

24. 24
Categorization of Devices
Direct Patient Contact
Indirect Patient Contact
- Devices that serve as a conduit for entry into the patient

25. 25
Categorization of Devices
Direct Patient Contact
Indirect Patient Contact
- Devices that serve as a conduit for entry into the patient
- Examples: Solution administration sets, extension
sets, transfer sets and blood administration sets

26. 26
Categorization of Devices
Grouping of Devices
- Devices of similar design and materials but different sizes
may be grouped and the worst case selected for testing
as a representative of the group.

27. 27
Categorization of Devices
Grouping of Devices
- Devices of similar design and materials but different sizes
may be grouped and the worst case selected for testing
as a representative of the group.
- Justification must be documented!

28. 28
Categorization of Devices
Grouping of Devices
- Devices of similar design and materials but different sizes
may be grouped and the worst case selected for testing
as a representative of the group.
- Justification must be documented!
Device kits and trays
- Initially determine residues for each EO and ECH
absorbing patients-contact device in the kit or tray, and
establish the worst-case device or devices. Additional
data can then be collected using just worst cases.

29. 29
Categorization of Devices
Grouping of Devices
- Devices of similar design and materials but different sizes
may be grouped and the worst case selected for testing
as a representative of the group.
- Justification must be documented!
Device kits and trays
- Initially determine residues for each EO and ECH
absorbing patients-contact device in the kit or tray, and
establish the worst-case device or devices. Additional
data can then be collected using just worst cases.
- Document the rationale!

30. 30
To view the complete presentation on ISO
10993-7
- Check out NAMSA’s Seminars
- You can view the entire ISO 10993 Series here
For information about the services NAMSA can
offer you regarding Ethylene Oxide
- Visit our Materials Characterization and Analytical
Chemistry page, or
- Download our Materials Characterization and
Analytical Chemistry brochure
For additional information
- Contact us at clientcare@namsa.com