SIST EN ISO 11737-1:2018/A1:2021 PDF
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 13
- Дата публикации:
- 23 июля 2021 г.
- ICS:
- 07.100.10
- Технический комитет:
- VAZ - Healthcare
No scope available
Abstract
Overview
EN ISO 11737-1:2018/A1:2021 is Amendment 1 to , adopted by CEN to support harmonized microbiological methods for the . The standard specifies procedures for the (commonly referred to as bioburden). This amendment updates the European adoption of the ISO document and clarifies its relationship to EU regulatory requirements (MDR 2017/745 and IVDR 2017/746).
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