ISO 11737-1:2018

Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products

Datum objavljivanja: 12. 1. 2018.

Опште информације

Trenutna faza: 90.92 Effective date: 2. 1. 2024.

Inicijator: ISO

Pripada: ISO/TC 198

Vrsta: Međunarodni standard

ICS: 11.080.01 07.100.10

Jezik: engleski francuski

Kupovina

Status: Objavljen

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Apstrakt

ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.
NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.
NOTE 2 See Annex A for guidance on Clauses 1 to 9.
ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022.
ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

Životni ciklus

PRETHODNO

POVUČEN
ISO 11737-1:2006

POVUČEN
ISO 11737-1:2006/Cor 1:2007

TRENUTNO

OBJAVLJEN
ISO 11737-1:2018
90.92 Odluka o izmeni ili reviziji standarda
2. 1. 2024.

ISPRAVKE / IZMENE

OBJAVLJEN
ISO 11737-1:2018/Amd 1:2021

REVIDIRAN OD

PROJEKAT
ISO/CD 11737-1.2

Nacionalna preuzimanja

SRPS EN ISO 11737-1:2018

ISS

Sterilizacija proizvoda za zaštitu zdravlja – Mikrobiološke metode – Deo 1: Određivanje populacije mikroorganizama na proizvodima

60.60 Standard objavljen

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