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I.S. EN 16602-70-55:2015

Current
Current

The latest, up-to-date edition.

SPACE PRODUCT ASSURANCE - MICROBIOLOGICAL EXAMINATION OF FLIGHT HARDWARE AND CLEANROOMS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
European foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Principles
5 Requirements
Annex A (normative) - Request for microbiological
        examination - DRD
Annex B (normative) - Microbiological examination
        test specifications and procedures (Work Proposal)
        - DRD
Annex C (normative) - Microbiological examination test
        report - DRD
Annex D (informative) - Procedures for swab assays
Annex E (informative) - Procedures for wipe assays
Annex F (informative) - Procedures for contact plates
Annex G (informative) - Procedure for active air sampling
Bibliography

Specifies test procedures for quantitative and/or qualitative microbiological examination of surfaces of flight hardware and in microbiologically controlled environments (e.g. cleanroom surfaces, cleanroom air, isolator systems).

DocumentType
Standard
Pages
66
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
EN 16602-70-55:2015 Identical

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 14698-2:2003 Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data
ISO 14644-2:2015 Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
EN 16602-70-71:2016 Space product assurance - Materials, processes and their data selection
ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
EN 16602-70-58:2015 Space product assurance - Bioburden control of cleanrooms
EN 16601-00-01:2015 Space systems - Glossary of terms
EN 16602-10-09:2014 Space product assurance - Nonconformance control system
ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
EN 16602-70-53:2015 Space product assurance - Materials and hardware compatibility tests for sterilization processes
EN 16602-70-01:2014 Space product assurance - Cleanliness and contamination control
EN 16602-20:2014 Space product assurance - Quality assurance

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