British Standards Institution

Source:: CEN
Committee:: CH/194 - Biological evaluation of medical devices
Categories:: Standardization. General rules | Metrology and measurement | Healthcare | Sterilization and disinfection | Medical devices. Biological evaluation

Scope

This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how this document is applied, are also included in the informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this part of ISO 10993.

NOTE This part of ISO 10993 does not specify limits for ethylene glycol (EG).

Purpose

EN ISO 10993-7-7:2008/A1:2022, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released.

The 2008 version of the standard is harmonised under the European Directive 93/42/EEC (MDD_93) pertaining to medical devices.

The Directive has been replaced by the regulation covering medical devices (MDR (EU) 2017/745).

The current version EN ISO 10993-7:2007/A1:2022 has not been harmonized under the MDD or MDR. This new Annex ZA is intended to change this.

For an assessment of this Annex ZA to take place, CEN TC 206 needs to include a European Amendment A 11 to this standard in its work programme.

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Standard timeline

1. Proposal

Proposal start date:

04/08/2023

Proposal end date:

11/09/2023

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

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Standards Development

Draft Decision CEN/TC 206 002/2023 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants

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