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GB 18279-2023
GB 18279-2023 Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices
Abstract
This document specifies the requirements for the development, validation, and routine control of the ethylene oxide sterilization process during the manufacturing of medical device products, and is applicable to medical devices that are sterilized with ethylene oxide.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Pending |
| Standard Code | GB 18279-2023 |
| CCS | Public medical equipment |
| ICS | Integrated disinfection and sterilization |
| Implement Date | 2026-10-01 |
Price
$ 111
Subtotal
$ 111
Tax
$ 0.00
Order Total (incl. tax)
$ 111