ISO 10993 Biological Evaluation of Medical Devices

Part Topic

Listing of Individual Parts

1 Evaluation and Testing

2 Animal Welfare Requirements

3 Tests for Genotoxicty, Carcinogenicity, and Reproductive Toxicity

4 Selection of Tests for Interactions with Blood

5 Tests for Cytotoxicity: In Vitro Methods

6 Tests for Local Effects after Implantation

7 Ethylene Oxide Sterilization Residuals

8 Selection and Qualification of Reference Materials for Biological Test

9 Framework for Identification and Quantification of Potential

Degradation Products

10 Test for Irritation and Sensitization

11 Test for Systemic Toxicity

12 Sample Preparation and Reference Materials

13 Identification and Quantification of Degradation Products from

Polymers

Continued

ISO 10993: Biological Evaluation of Medical Devices (Continued)

Part Topic

Listing of Individual Parts

14 Identification and Quantification of Degradation Products from

Ceramics

15 Identification and Quantification of Degradation Products from Coated and Uncoated Metals and Alloys

16 Toxicokinetic Study Design for Degradation Products and Leachables

17 Establishment of Allowable Limits for Leachable Substances

Device Categories: Definitions and Examples

Device Categories

Examples

Surface device Skin

Mucous membrane

External communicating device

Breached or compromised surfaces

Blood path, indirect

Devices that contact intact skin surfaces only. Examples include electrodes, external prostheses, fixation tapes, compression bandages, and monitors of various types.

Devices communicating with intact mucosal membranes. Examples include contact lenses, urinary catheters, intravaginal and intraintestinal devices (stomach tubes, sigmoidoscopes, colonoscopes, gastroscopes), endotracheal tubes, bronchoscopes, dental prostheses, orthodontic devices, and IUDs.

Devices that contact breached or otherwise compromised external body surfaces. Examples include ulcer, burn and granulation tissue dressings or healing devices, and occlusive patches.

Devices that contact the blood path at one point and serve as a conduit for entry into the vascular system. Examples include solution administration sets, extension sets, transfer sets, and blood administration sets.

Continued

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