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ÖNORM EN ISO 11737-1:2021-11

Действует
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018 + Amd 1:2021) (consolidated version)
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 10012:2003
Действует
Measurement management systems -- Requirements for measurement processes and measuring equipment — 26 стр.
ISO 13485:2016
Действует
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 46 стр.
ISO 15189:2012
Действует
Medical laboratories -- Requirements for quality and competence — 58 стр.
ISO/IEC 17025:2005
Заменен
General requirements for the competence of testing and calibration laboratories — 36 стр.
ÖNORM EN ISO 11737-1:2019-03
Заменен
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)

На этот документ ссылаются

DIN EN ISO 14160:2011-10
Отменен
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011); German version EN ISO 14160:2011 — 48 стр.
ÖNORM EN ISO 11737-1:2019-03
Заменен
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)