ISO/TR 21582:2021 PDF
Pyrogenicity — Principles and methods for pyrogen testing of medical devices
Pyrogenicity — Principles and methods for pyrogen testing of medical devices
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 16
- Дата публикации:
- 12 июля 2021 г.
- Издание:
- ISO TR 21582 edition 1 version 1
- ICS:
- 11.100.20
This document specifies the principles and methods for pyrogen testing of medical devices and their materials.
Abstract
Overview
ISO/TR 21582:2021 - "Pyrogenicity - Principles and methods for pyrogen testing of medical devices" is a technical report from ISO/TC 194 that summarizes principles, methods and practical considerations for assessing of medical devices and their materials. The document addresses causes of febrile responses (pyrogens), test selection and procedures, and the current state of accepted methods for devices that contact blood, lymph, cerebrospinal fluid (CSF) or otherwise interact systemically with humans.
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