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ANSI/AAMI/ISO 13408-7:2012(R2018)

Current
Current

The latest, up-to-date edition.

ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-17-2018

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 13408-7:2012
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Aseptic process definition
6 Manufacturing environment
7 Equipment
8 Personnel
9 Manufacture of the product
10 Process simulation
11 Test for sterility
Annex A (informative) - Risk assessment for aseptic
        processing - Quality risk management method
Annex B (informative) - Selection of a sample for
        testing for microbial contamination
Annex C (informative) - Testing options for process
        simulation
Bibliography

Describes requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied.

Committee
WG 09
DocumentType
Standard
ISBN
978-1-57020-455-5
Pages
36
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current

Standards Relationship
ISO 13408-7:2012 Identical

ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 14971:2007 Medical devices Application of risk management to medical devices

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