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ISO 11607-2:2019
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| Price | Price USD 106.00 | ||
| Rating | Rating | ||
| Buy | Buy Add to Cart | ||
| Description |
Description
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. |
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| Standard Number | Standard Number ISO 11607-2:2019 | ||
| Title | Title ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes | ||
| Status | Status Published | ||
| Publication Date | Publication Date 31 Jan 2019 | ||
| Cross References | Cross References | ||
| Descriptors | Descriptors | ||
| ICS | ICS 11.080.30 | ||
| Committee | Committee ISO/TC 198 Sterilization of health care products | ||
| ISBN | ISBN | ||
| Publisher | Publisher PECB Store | ||
| Format | Format PDF | ||
| Delivery | Delivery NO | ||
| Pages | Pages 13 | ||
| File Size | File Size KB |
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