BS EN ISO 11737-1:2018 PDF

Sterilization of health care products. Microbiological methods - Determination of a population of microorganisms on products

First page of standard BS EN ISO 11737-1:2018

Open preview (PDF)

Title (English):

BS EN ISO 11737-1:2018

Sterilization of health care products. Microbiological methods - Determination of a population of microorganisms on products

Document status:: Withdrawn
Format:: Electronic (PDF)
Publication date:: June 30, 2018
ICS:: 07.100.10
Technical committee:: CEN
SKU:: BS EN ISO 11737-1:2018

Delivery type:

Full version50 €Read online 24h10 €Read online 72h15 €

Document language:

enru

Delivery time:Immediate download

Price:50 €

Abstract

1 Scope This document 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.

This document 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.

This document does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

Related standards

Mentioned in the description and other BS standards

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.

NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442-3, ICH Q5A(R1) and ISO 13022.

This document does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

BS EN ISO 11737-1:2018 PDF

Abstract

Related standards

Abstract

Related standards

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or…

Geometrical product specifications (GPS). Indication of surface texture in technical product documentation

Safety of earth-moving machinery - Specification for lighting, signalling and marking lights, and reflex-refl…

Airframe rolling bearings. Technical specification.

Road vehicles. Types. Terms and definitions.

Water quality. Evaluation of the ´ultimate´ anaerobic biodegradability of organic compounds in digested sludg…

Petroleum and natural gas industries. Drilling and production equipment. Hoisting equipment. Hoisting equipme…

Specification for lifts, escalators, passenger conveyors and paternosters. Building construction requirements.