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15/30321502 DC : 0

Superseded

Superseded

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BS EN ISO 11138-1 - STERILIZATION OF HEALTH PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS

Available format(s)

Hardcopy , PDF

Language(s)

English

Superseded date

04-30-2017

Superseded by

BS EN ISO 11138-1:2017

US$28.75
Excluding Tax where applicable
Summarise this standard

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
5 Specific manufacturing requirements
6 Determination of resistance
7 Culture conditions
Annex A (normative) - Determination of viable
        count
Annex B (normative) - Determination of growth
        inhibition by carriers and primary packaging
        materials exposed to sterilization processes
Annex C (normative) - D value determination by
        survivor curve method
Annex D (normative) - D value determination by
        fraction negative method
Annex E (normative) - Survival-kill response
        characteristics
Annex F (informative) - Relationship between
        components of biological indicators
Bibliography

BS EN ISO 11138-1.

Committee
CH/198
DocumentType
Draft
Pages
50
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

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A newer version of this standard is available.

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US$28.75
Excluding Tax where applicable